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Clinical Interventions in Aging 2019:14 145–154 Clinical Interventions in Aging This article was published in the following Dove Medical Press journal: Clinical Interventions in Aging Dovepress submit your manuscript | www.dovepress.com Dovepress 145 O r I g I n A l r e s e A r C h open access to scientific and medical research Open Access Full Text Article http://dx.doi.org/10.2147/CIA.s191832 effects of a fall prevention program in elderly: a pragmatic observational study in two orthopedic departments Bodil røyset1 Bente A Talseth-Palmer2–4 stian lydersen5 Per g Farup6,7 1Department for Medicine and rehabilitation, Møre og romsdal hospital Trust, Ålesund, norway; 2Department for research, Innovation, education and Competence Development, Møre og romsdal hospital Trust, Molde, norway; 3Department of Clinical and Molecular Medicine, Faculty of Medicine and health sciences, norwegian University of science and Technology, Trondheim, norway; 4school of Biomedical sciences and Pharmacy, Faculty of health and Medicine, University of newcastle and hunter Medical research Institute, newcastle, nsW, Australia; 5regional Centre for Child and Youth Mental health and Child Welfare, Department of Mental health, Faculty of Medicine and health sciences, norwegian University of science and Technology, Trondheim, norway; 6Department of research, Innlandet hospital Trust, Brumunddal, norway; 7Unit for Applied Clinical research, Department of Clinical and Molecular Medicine, Faculty of Medicine and health sciences, norwegian University of science and Technology, Trondheim, norway Purpose: Falls are a common adverse event experienced by elderly in hospitals. This study assessed the effects of a fall prevention program on the rate of fallers, the patient safety culture, and patient-perceived safety. Materials and methods: Two orthopedic departments in different towns in Norway partici- pated in the study. A comprehensive, multifactorial fall prevention program was implemented in one of the departments, the other one was used for control. The changes in the outcomes in the two departments from before to after the intervention were compared. All patients above 64 years of age admitted to the two departments in a 1-year period before and after the interven- tion were included. All employees at the two departments were invited to participate in surveys measuring the patient safety culture, and a selection of the patients reported patient-perceived safety. The primary outcome was the rate of fallers. Secondary outcomes were the employees’ perceived patient safety culture (measured with the Safety Attitudes Questionnaire) and patient- perceived safety (measured with Norwegian Patient Experience Questionnaire). Results: Falls were registered in 114 out of 3,143 patients (3.6\%) with 17,006 days in the hospital. Ten patients had two falls, giving a fall rate of 7.3 falls/1,000 days in the hospital. The number of fallers before and after the intervention in the intervention department were 37/734 (5.04\%) and 31/735 (4.22\%), P=0.46, and in the control department, 25/811 (3.08\%) and 21/863 (2.43\%), P=0.46. The difference between the changes in the two departments was not statistically significant; 0.17\% (95\% CI: -2.49 to 2.84; P=0.90). There were also no significant differences in the changes in patient safety culture and patient-perceived safety. Conclusion: The fall prevention program revealed no significant effect on the rate of fallers, the patient safety culture, or patient-perceived safety. Keywords: accidental falls, accident prevention, adverse effects, patient safety, safety culture Introduction The report “To Err is Human,” published in 1999, estimated adverse events in hospitals to cause 44–98,000 deaths in the USA every year.1 The report draws attention to an important health care-related concern and has resulted in a significant increase in patient safety efforts, such as system-based interventions, practical clinical initiatives, and research. In 2004, the WHO established the network World Alliance for Patient Safety, which aims to coordinate, disseminate, and accelerate improvements in patient safety worldwide.2 Systems for reporting adverse events are in use internationally for quality assurance and patient safety.3–5 Worldwide, falls are one of the most commonly reported adverse events in hospitals with prevalence rates in the order of 10 per 1,000 patient days or 5\%–15\% of the patients Correspondence: Per g Farup Department of research, Innlandet hospital Trust, PB 104, n-2381 Brumunddal, norway Tel +47 9 481 8603 Fax +47 6 115 7437 email [email protected] Journal name: Clinical Interventions in Aging Article Designation: Original Research Year: 2019 Volume: 14 Running head verso: Røyset et al Running head recto: Effects of a fall prevention program in elderly DOI: 191832 https://www.dovepress.com/terms.php http://creativecommons.org/licenses/by-nc/3.0/ https://www.dovepress.com/terms.php http://www.dovepress.com/permissions.php www.dovepress.com www.dovepress.com www.dovepress.com http://dx.doi.org/10.2147/CIA.S191832 https://www.facebook.com/DoveMedicalPress/ https://www.linkedin.com/company/dove-medical-press https://twitter.com/dovepress https://www.youtube.com/user/dovepress mailto:[email protected] Clinical Interventions in Aging 2019:14submit your manuscript | www.dovepress.com Dovepress Dovepress 146 røyset et al and are associated with both minor and major injuries.6–8 Preventive measures have been taken with conflicting results. Overall, fall prevention exercise interventions have shown no effect, while vitamin D supplement has reduced the rate of falls but not the risk of falls in elderly in nursing homes.9,10 Multifactorial interventions in hospitals have shown a reduc- tion in the rate of falls and an inconclusive trend for the risk of falling according to a Cochrane review.10 In large, fall pre- vention measures in hospitals have been disappointing.10–13 Norway has since 1994 had a national system for report- ing adverse events in hospitals.14 The database has been used to plan and implement prevention activities related to frequent and serious adverse events. Eleven percent of all reports from the specialized health services were incidents related to falls.14 In January 2011, the Norwegian health minister launched a national patient safety campaign called “In Safe hands.”15 The campaign had three aims: 1) reduce patient-related adverse events, 2) build sustainable systems and structures for patient safety, and 3) improve the patient safety culture. Hospitals and primary care units were invited to participate in 16 specific and measurable areas for improvement; one of the areas was fall prevention. One out of four orthopedic departments at different sites in Møre og Romsdal Hospital Trust, Norway, participated actively in the national multi- factorial fall prevention program. This pragmatic observational study aimed to compare the differences in the changes from before to after the fall prevention intervention in the rate of fallers, the employees’ perceived patient safety culture, and the patient experienced safety between the department with the intervention and the department without the intervention in the same hospital trust. The hypothesis was that the fall intervention program would reduce the rate of fallers in the intervention department (ID) compared with the department without the intervention. A secondary aim was to study predictors of fallers. Materials and methods study design The study was performed in two orthopedic departments in Møre og Romsdal Hospital Trust, located in different cities. The hospital trust serves a population of 265,000 inhabitants. The ID served a population of 62,000 inhabitants and had ~1,400 admissions each year. The corresponding numbers for the control department (CD) were 95,000 inhabitants and 2,000 admissions. From November 2012 to September 2013, the fall prevention measures were implemented in one of the orthopedic departments hereafter referred to as the ID. The intervention was performed as proposed by the national patient safety campaign “In safe hands.”15 The department that did not participate in the safety campaign was used for comparison and will be referred to as the CD. Comparisons were made between two departments in the same hospital trust with approximately the same size and organizational culture, the same expectations and challenges from the director and the board, and well-matched patients from the same region. In both departments, all falls were registered in a 12-month period before (from November 2011 to October 2012) and after (from November 2013 to October 2014) the interven- tion. Before (in April 2012) and after (in April 2014) the intervention, all employees in both departments were invited to participate in a survey, measuring patient safety culture. The survey was a part of the national patient safety campaign and performed anonymously. Similarly, two cross-sectional studies conducted by The Norwegian Institute of Public Health were performed among a selection of patients admitted to the orthopedic department in 2012 and 2014 (before and after the intervention). They were invited to participate in a survey measuring patient- perceived safety. Figure 1 shows the timeline for data used in different analyses. Participants The fall registration included all patients above 64 years of age admitted to the ID and CD during the two registration periods and with a stay of at least 24 hours’ duration. All employees at the two departments were invited to par- ticipate in surveys measuring the patient safety culture. The exact number of employees in the two departments asked to participate was unknown. Since the surveys were performed anonymously, no information was available on the subjects’ characteristics, and therefore no matching was possible. Randomly selected patients from the two orthopedic departments were invited to participate in surveys measuring patient-experienced safety. The surveys were part of national surveys, and the number and characteristics of patients asked to participate are unknown. Variables Participants The following data were registered for all patients admitted to the hospital during the two registration periods: age (years), gender, operation (yes/no), fall (yes/no; if yes, number of falls, point of time related to the admission, operation, and time of fall; daytime/evening/night), fall as the cause of www.dovepress.com www.dovepress.com www.dovepress.com Clinical Interventions in Aging 2019:14 submit your manuscript | www.dovepress.com Dovepress Dovepress 147 effects of a fall prevention program in elderly admission (yes/no), fall causing fracture (yes/no), fall for- mally reported in the hospital’s systems for adverse events (yes/no), fall screening performed (yes/no), and the duration of the stay (days). Fall Fall was defined according to WHO as “an event which results in a person coming to rest inadvertently on the ground or floor or other lower level.”16 Falls were registered retrospectively. Four individuals shared the reviewing of all the medical records written by doctors, nurses, and physiotherapists during the registration periods. They read parts of the medical records and searched the records with appropriate keywords to retrieve and find information about all falls. Also, the hospital’s formal registry of adverse events was searched and the findings compared with the medical records. Fall prevention interventions Two doctors and three nurses from the ID participated in the Patient Safety Campaign’s national workgroup for prevention of falls. The group had meetings and published national guidelines that proposed tools, training programs, and improved procedures to prevent falls. The interventions were implemented in the ID. The fall prevention program, not unlike the 6-PACK programme,13 was described in detail (in Norwegian).17 It consisted of 1) seven examples of risk factors which might cause falls (diseases and medications, movement, cognitive behavior, vision, continence, nutrition, and the room and surroundings), 2) methods to detect the risk factors, and 3) measures to avoid falls or protect the patient in case of a fall. The interventions were multifaceted and included short- and long-term activities to prevent falls. To detect risk factors, a fall screening was performed with the Norwe- gian version of the risk assessment tool for falls in elderly “STRATIFY” (score 0–5).18 Patients were scored on five risk factors, each of them is one point: falls last 3 months, reduced vision, uneasy patient, frequent visits to the toilet, and reduced walking/movement ability. Standard measures for all patients were a review of the medication and infor- mation about the room and the surroundings. There were individually tailored measures such as to lock the wheels of the bed and the tables, make sure that the patients can reach the alarm and their personal belongings, lower the bed to the lowest level, adjust day and night lightening, and remove furniture and equipment that may cause falls. In patients with a score of 2 or more, a comprehensive individual plan for fall prevention was worked out, documented in the medical records, and communicated to the staff responsible for the patient. The plan included practical initiatives like adjusting the beds, proper illumination, instructions not to leave the bed unaided, and the use of appropriate shoes. There were also long-term measures like the treatment of underlying diseases, changes in medication associated with the risk of fall, physical training, and healthier dietary habits. Dur- ing the intervention, reports about the process (number of patients screened, etc) and the results (number of falls, etc) were regularly sent to the authorities. The governmental intervention was designed for use in hospitals, care facilities, and patients living at home. Most of the proposed activities aimed at preventing falls in a long time perspective. The fall intervention was added to the routine preventive measures, which were performed in the CD at the employees’ discre- tion. The patients were offered suitable, often low, beds with bed staffs, special surveillance if they were confused Figure 1 The study design. Abbreviations: CD, control department; ID, intervention department. www.dovepress.com www.dovepress.com www.dovepress.com Clinical Interventions in Aging 2019:14submit your manuscript | www.dovepress.com Dovepress Dovepress 148 røyset et al or dizzy, and were urged to ask for help if they wanted to get out of the bed. Patient safety culture Patient safety culture was measured with the validated Norwegian version of the Safety Attitudes Questionnaire (SAQ).19,20 The national campaign used only two factors (teamwork climate and safety climate) out of the six factors in the questionnaire. According to the scoring algorithm, some answers were recoded and the results transformed into a scale 0–100; high values indicate a good culture. Patient-perceived safety The Norwegian Patient Experience Questionnaire (PEQ) has been used regularly in Norwegian hospitals since 1996.21 This study used ten out of 52 questions that measure the patient- experienced patient safety.22 The answers were transformed according to the scoring algorithm into a scale 0–100; high values indicate high patient-perceived safety. statistics The results have been reported as mean (SD), median (range), and number (with proportion in brackets). Com- parisons between groups were analyzed with Fisher’s exact test, Student’s t-test, and Mann–Whitney U-test depending on the type of data and distribution, and logistic regression analyses for the study of predictors of falls. For continuous variables, the comparisons of changes from before to after the intervention were performed with linear regression with the point of time, department, and their interaction as covariates. For dichotomous variables, the risk difference was calculated with a semirobust generalized linear model for a binary out- come. In each analysis, we included all the cases with data on the relevant variables (“available case analysis”). P-values ,0.05 were judged as statistically significant. The analyses were performed with IBM SPSS Statistics for Windows, version 23.0 (IBM Corporation, Armonk, NY, USA), except for the risk difference for dichotomous variables that were analyzed with STATA Release 13 (StataCorp LP, College Station, TX, USA). ethics approval The project was approved by the Regional Committees for Medical and Health Research Ethics (REK) in Norway (approval number REK 2015/2469). A waiver of consent was granted in this study as the project was deemed not to be a medical or health research project according to the Health Research Act. By virtue of regulations of February 7, 2009, #989 REK is delegated authority to grant exemption from the duty of confidentiality pursuant to the Health Personnel Act, §29 first paragraph and the Act of First Amendment, §13 first paragraph, and a waiver of consent is given to obtain the data mentioned in the application (see registration variables under participants) as the project is of genuine interest to society and the data collection does not significantly interfere with the welfare and integrity of the patients. The data were anonymized after registration. The Norwegian Data Inspec- torate represented by the Privacy Ombudsman for research at Møre og Romsdal Hospital Trust approved the responses to the questionnaires SAQ and PEQ for research after ano- nymization. The study was registered in ClinicalTrials.gov NCT03354468; date of registration: November 24, 2017; “Retrospectively registered.” Results In all, 3,143 patients with 17,006 days in the hospital were included in the study. Falls were noted in 114 patients, ten patients had two falls, which gave an overall fall rate of 3.6\% of the patients or 7.3 falls/1,000 days in the hospital. Table 1 shows the patients’ characteristics and the results separately for the ID and CD with comparisons between the departments. The overall prevalence rates of fallers in both the regis- tration periods in the ID and CD were 68/1,469 (4.6\%) and 46/1,674 (2.7\%), respectively (P=0.005), and the prevalence rates of fallers before and after the intervention were 62/1,545 (4.0\%) and 52/1,598 (3.3\%), respectively (P=0.30). Patients with falls had a longer stay in hospital compared with those who did not fall; the median lengths were 7 days (range 1–164) and 4 days (range 0–56), respectively (P,0.001). The prevalence rate of fallers in patients with and without an operation were 91/2,274 (4.0\%) and 22/824 (2.7\%), respectively (P=0.08). In the ID, the fall risk evaluation was performed in 327/727 (45\%) of the patients after the intervention. The number of fallers in patients evaluated and not evaluated for fall risk were 17/327 (5.2\%) and 14/400 (3.5\%) (P=0.27), respectively, and the number of fallers formally registered in the hospital registry of adverse events before and after the intervention were 2/37 (5.4\%) and 4/31 (12.9\%) (P=0.40), respectively. Table 2 shows unadjusted and adjusted predictors of fallers. In the ID and CD, the changes in the faller rates from before to after the intervention were 0.82\% and 0.65\%, respectively, the difference was not statistically significant (P=0.90). Table 3 shows the details and Figure 2A visualizes the main results. www.dovepress.com www.dovepress.com www.dovepress.com https://ClinicalTrials.gov Clinical Interventions in Aging 2019:14 submit your manuscript | www.dovepress.com Dovepress Dovepress 149 effects of a fall prevention program in elderly In all, 130 and 128 employees had satisfactorily filled in the teamwork and safety culture parts of the SAQ, respec- tively. The patient safety culture did not differ significantly between the two departments. Table 1 shows the overall results in the two departments, and Table 3 shows the culture in the two departments before and after the intervention with comparisons between the departments and the time of regis- tration. The changes in the teamwork and safety climate from the first to the second registration did not differ significantly between the departments. Before and after the intervention, 62 and 76 patients in the ID and 26 and 33 patients in the CD, respectively, answered the patient-perceived safety questionnaire. The patient- perceived safety scores did not differ significantly between the departments and were not significantly influenced by the intervention. Table 1 shows the overall results, and Table 3 shows the results in the two departments before and after the intervention with comparisons between the departments and time of registration. The main outcomes of the study were the comparisons of the changes in the faller rates, patient safety culture, and patient-perceived safety from before to after the intervention between the departments. There was no significant effect of the intervention in either of the variables (Table 3 – the Table 1 Patients’ characteristics and the overall results from both registration periods in the two departments Patient characteristics and results Intervention department (ID) n=1,469 Control department (CD) n=1,674 Statistics, P-values Women/men 943 (64\%)/526 (36\%) 1,072 (64\%)/602 (36\%) 0.94a Age (years) 77.7 (8.5) 78.0 (8.4) 0.41b Days in hospital 4.0 (0 to 164) 4.0 (0 to 53) 0.58c Operation 1,036 (71\%) 1,271 (76\%) 0.001a Fall as the cause of the admission 538 (37\%) 716 (43\%) ,0.001a Falls 68 (4.6\%) 46 (2.7\%) 0.005a Falls causing fracture 4/68 (5.9\%) 3/46 (6.5\%) 1.00a Falls causing operation 3/68 (4.4\%) 3/46 (6.5\%) 0.68a Fall: days after admittance 3.0 (0 to 31) 4.0 (0 to 16) 0.07c Fall: days after an operation 2.0 (-6 to 32) 3.5 (1 to 15) 0.004c Fall: day/evening/night 23 (34\%)/18 (26\%)/27 (40\%) 21 (46\%)/8 (17\%)/17 (37\%) 0.38a Falls formally reported 6/66 (9.1\%) 1/46 (2.2\%) 0.24a Teamwork climated 77 (16) 78 (15) 0.65b safety climatee 75 (17) 76 (17) 0.98b Patient-perceived safetyf 89 (18) 85 (17) 0.10b Notes: The results are given as number and proportion (\%), mean (sD), and median (range). aFisher’s exact test; bt-test; cMann–Whitney U-test. dnumber of subjects in the ID and CD were 76 and 54, respectively. enumber of subjects in the ID and CD were 75 and 53, respectively. fnumber of patients in the ID and CD were 138 and 59, respectively. Table 2 Comparisons of the patients with and without a fall and predictors of fallers Variables Faller Predictors of fallersa Yes (n=114) No (n=3,029) P-value OR 95\% CI P-value gender (female/male) 68 (60\%)/46 (40\%) 1,947 (64\%)/1,082 (36\%) 0.321b 1.30 0.88–1.94 0.19 Age (years) 80 (65–97) 77 (64–101) 0.025c 1.02 0.996–1.05 0.11 Department (ID/CD) 68 (60\%)/46 (40\%) 1,401 (46\%)/1,628 (54\%) 0.005b 0.57 0.39–0.84 0.005 Point of time (before/after the intervention) 62 (54\%)/52 (46\%) 1,483 (49\%)/1,546 (51\%) 0.294b 0.90 0.61–1.32 0.58 Fall as the cause of the admission 48 (42\%) 1,206 (40\%) 0.627b 1.04 0.68–1.58 0.86 Operation during hospitalization 92 (81\%) 2,215 (73\%) 0.084b 1.38 0.85–2.24 0.20 Days in hospital 7.0 (1–164) 4.0 (0–56) ,0.001c 1.08 1.05–1.10 ,0.001 Notes: The results are given as number (proportion), median (range), and Or with 95\% CI. alogistic regression analysis with faller as the dependent variable and all the variables in the table as covariates; bFisher’s exact test; cMann–Whitney U-test. Abbreviations: CD, control department; ID, intervention department. www.dovepress.com www.dovepress.com www.dovepress.com Clinical Interventions in Aging 2019:14submit your manuscript | www.dovepress.com Dovepress Dovepress 150 røyset et al Table 3 Main variables in the two departments before and after the intervention Variables ID before ID after Statistics, P-values CD before CD after Statistics, P-values ID vs CD before, P-values ID vs CD after, P-values Difference in change (95\% CI) Statistics, P-values Faller, n (\%) 37/734 (5.04) 31/735 (4.22) 0.460a 25/811 (3.08) 21/863 (2.43) 0.456a 0.052a 0.048a 0.17\% (-2.49 to 2.84) 0.90b Teamwork climate,c mean (sD) 77 (18) 77 (13) 0.986d 81 (13) 75 (16) 0.130d 0.266d 0.609d 6.3 (-4.6 to 17.3) 0.26e safety climate,f mean (sD) 74 (18) 77 (16) 0.408d 80 (17) 72 (18) 0.094d 0.195d 0.201d 11.3 (-0.8 to 23.5) 0.07e Patient- perceived safety,g mean (sD) 91 (16) 88 (19) 0.312d 83 (18) 86 (17) 0.563d 0.052d 0.614d -5.8 (-16.8 to 5.2) 0.30e Notes: The number of fallers, the patient safety culture, and the patient-perceived safety in the two departments before and after the intervention with comparisons between the time points and comparisons of the changes from before to after between the departments are shown. A positive difference in the changes is in favor of the ID. The results are given as number (proportion in \%); mean (sD), and differences in the changes of proportions with 95\% CI. aFisher’s exact test; bgeneralized linear model for a binary outcome; cnumber of subjects in the ID department before and after the intervention were 37 and 39, respectively, and in the CD 27 both before and after. dstudent’s t-test. elinear regression. fnumber of subjects in the ID department before and after the intervention were 36 and 39, respectively, and in the CD 26 and 27, respectively. gnumber of patients in the ID department before and after the intervention were 62 and 76, respectively, and in the CD 26 and 33, respectively. Abbreviations: CD, control department; ID, intervention department. Figure 2 Changes from before to after the intervention. Notes: The four parts of the figure show: (A) the proportions of fallers (\%); (B) the teamwork climate (mean); (C) the safety climate (mean); (D) the patient-perceived safety before and after the intervention in the departments with and without the intervention. The text gives the differences in the changes between the departments from before to after the intervention; positive values indicate changes in favor of the intervention department. www.dovepress.com www.dovepress.com www.dovepress.com Clinical Interventions in Aging 2019:14 submit your manuscript | www.dovepress.com Dovepress Dovepress 151 effects of a fall prevention program in elderly column “Difference in change”). Figure 2A–D shows the results with the differences in changes between the depart- ments from before to after the intervention. Discussion We observed no differences in the changes in the faller rates, patient safety culture, or patient-perceived safety from before to after the intervention between the two departments and conclude that the fall intervention had no clinically significant effect at the time of observation. An initial temporary effect during the implementation period might have been missed due to the long period between the two registrations (1 year). The fall rate in this study (7.3 falls per 1,000 patient days in hospital) was in accordance with other studies on elderly patients.6,8 A more conscientious registration of falls in the medical records in the ID is the most likely explanation of the higher faller rate in this department compared with the CD. Patients with falls were older and had more days in the hospital, but only days in hospital was an independent predictor of fall. It is unknown if the fall caused prolonga- tion of the stay in the hospital or if frail patients have more extended stays and more falls. Independent of the causation, patients with long stays should receive extra preventive inter- ventions and surveillance. Both older age and length of stay, independent of injury caused by the fall, have been associated with fall in other studies.23,24 Risk factors associated with falls in other studies, but not in this one, are previous falls and gender.24,25 Information about falls over a longer period before the admission was not available. This information and not only fall as the cause of admittance could have been a predictor of falls. The lack of effect on the faller rate … Observational Study Medicine ® OPEN Interventions aimed at lo neliness and fall prevention reduce frailty in elderly urban population Sanja Ožić, MPHa, Vanja Vasiljev, MSc, PhDb,c, Vanja Ivković, MD, PhDc,d, ∗ , Lovorka Bilajac, MSc, PhDb,e, Tomislav Rukavina, MD, PhDb,c,e Abstract Frailty is a pronounced symptom of aging associated with multiple comorbid states and adverse outcomes. The aim of this study was to evaluate the impact of 2 interventions, one based on prevention of falls and the other on prevention of loneliness, on total frailty and dimensions of frailty in urban community-dwelling elderly as well as associations with independent living. This prospective interventional study followed up 410 persons aged 75 to 95. The participants of the control and intervention groups were monitored through a public health intervention programme. The level of frailty was measured by the Tilburg Frailty Indicator (TFI) questionnaire and the factors of independent living were analyzed using validated questionnaires. After 1 year, physical frailty measured in the control group showed a statistically significant increase (r=�0.11), while in the intervention groups physical frailty did not increase (both P>.05). Psychological frailty measured after 1 year in the control group was significantly higher (r=�0.19), as well as in the group where the public health interventions to reduce loneliness were carried out (r=� 0.19). Psychological frailty did not increase in the group in which public health interventions to prevent falls were carried out, and social frailty did not increase at all in the study period. The total level of frailty in the control group after 1 year was significantly increased (r=�0.19), while no increase was seen in the overall frailty in the intervention group. Multivariate analysis has shown that both interventions where independently associated with lower end frailty. Additionally, higher baseline frailty and visit to a physician in the last year were positively associated with higher end-study frailty level, while higher number of subjects in the household and higher total psychological quality of life (SF-12) were independently associated with lower end-study frailty. Only in the prevention of falls group there was no increase in restriction in the activities of daily living throughout study follow-up. Public health interventions to prevent falls and to prevent loneliness have a positive effect on the frailty and independent living of the elderly living in their own homes in an urban community. Abbreviations: ADL = activities of daily living, GARS = Groningen Activity Restriction Scale, IADL = instrumental activities from daily living. Keywords: elderly persons, frailty, independent living, public health interventions 1. Introduction Frailty is perceived as a geriatric syndrome which is a reflection and consequence of the dysfunction of several organ systems.[1–3] Editor: Yi Zhu. The authors have no conflicts of interest to disclose. a Zagreb Holding, City of Zagreb, b Department of Social Medicine and Epidemiology, Faculty of Medicine, c Department of Public Health, Faculty of Health Sciences, University of Rijeka, d Department of Nephrology, Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, e Educational Institute of Public Health of the Primorje-Gorski Kotar County, Croatia. ∗ Correspondence: Vanja Ivković, Faculty of Health Sciences, University of Rijeka, Viktora Cara Emina 5, 51000 Rijeka, Croatia (e-mail: [email protected]). Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. How to cite this article: Ožić S, Vasiljev V, Ivković V, Bilajac L, Rukavina T. Interventions aimed at loneliness and fall prevention reduce frailty in elderly urban population. Medicine 2020;99:8(e19145). Received: 2 September 2019 / Received in final form: 22 December 2019 / Accepted: 10 January 2020 http://dx.doi.org/10.1097/MD.0000000000019145 1 While no common and universally accepted definition exists, it is most commonly defined as a state associated with increased vulnerability to adverse outcomes due to the decline in reserve and functions in multiple physiological systems.[4] Studies in Europe which examined overall (defined as physical or psychosocial) frailty or frailty defined as complex phenotype point to the category of “severely frail,” which includes between 1/3 and 1/2 of elderly persons living in the European states.[5,6] Two recent meta-analyses presented data on epidemiology of frailty. Meta-analysis by O’Caoimh et al[7] which analyzed data on frailty, defined using any definition, irrespective of the method of data collection or instrument used, from 68 unique datasets with data from 22 European countries showed that overall prevalence of frailty in the elderly population is 18\%, being 12\% in community-dwelling elderly and 45\% in non-community based studies. The other meta-analysis by Siriwardhana et al[8] which examined the prevalence of frailty and prefrailty measured by any assessment method among community-dwelling older adults in low-income and middle-income countries showed that the prevalence of frailty varied from 3.9\% in China to 51.4\% in Cuba, while the prevalence of prefrailty ranged from 13.4\% in Tanzania to 71.6\% in Brazil. Additionally, demographic data on aging indicate that the number of elderly persons with frailty will increase, which is why frailty is defined as a priority in public mailto:[email protected] http://creativecommons.org/licenses/by-nc/4.0 http://creativecommons.org/licenses/by-nc/4.0 http://dx.doi.org/10.1097/MD.0000000000019145 Ožić et al. Medicine (2020) 99:8 Medicine health and health care system for the elderly.[9,10] In cohort studies, it was found that the prevalence of frailty defined by various methods ranges from 4\% to 59\% but there is a significant difference between various methodological approaches and there are ambiguities in comparing data from different geographic areas.[5,6] The clinical picture of frailty in the elderly is characterized by an increased vulnerability caused by reduced functional abilities in all physiological systems, which results in the reduced ability to face the everyday or acute stressors.[11–14] Frail elderly persons are classified as vulnerable social groups because of the effects on their quality of life, the institutionalized care, and unwanted health and death outcomes. Especially vulnerable are elderly persons with concomitant chronic diseases, exposed to acute infections or acute confusion and those who were exposed to falls.[15–18] In this study of frailty among the elderly, an integrative model of frailty based on a multidimensional approach was used, with an estimation of physical, psychological, and social dimensions of frailty.[19] Research shows that most of the elderly in European countries prefer to remain independent and continue to live in their own homes.[20,21] Numerous support programmes help elderly persons to stay in their homes and remain independent as long as possible,[21,22] because, according to the research, most of the elderly in Europe are still in good condition and capable of living independently.[23] However, according to the research data, to be capable to live independently at home an elderly person needs a certain state of mental health and satisfactory functional capaci- ty.[24,25] Therefore, in this research of independent living of the elderly, focus has been placed on the analysis of the functional capacity of theelderly.The recognitionoffrailty inthe elderly andan early intervention within the framework of primary health care are important for the care of the elderly. Interventions aiming to reduce frailty contribute tochanges inthe levelsof frailtyandaffectthe costs for the elderly persons’ health care. The rationale for designing and studying interventions aiming to prevent the frailty in the elderly has shown the efficacy of combined interventions.[4,26] However, while it has been shown that frailty is associated with higher risk of falls and more pronounced loneliness, there is still insufficient evidence of theeffectofinterventionsaimedatdecreasingriskoffallsandlevelof loneliness on frailty. Faber et al[27] examined the effects of a 20-week moderate intensity group-exercise program on falls in nonfrail, pre- frail, and frail individuals. The randomized trial showed that frailty was a strong effect modifier and that, surprisingly, the intervention had opposite effects in different frailty classifications, non- significantly reducing fall risk in pre-frail subjects and significantly increasing fall risk in frail subjects and the study concluded that physical interventions to reduce falls should be targeted to nonfrail and pre-frail subjects and could be counterproductive and increase falls in frail persons. Moreover, there is a clear association between loneliness and physical and total frailty[28–30] and different activities have been shown to mediate the relationship between loneliness and frailty[31] so our hypothesis was that interventions aimed at loneliness and risk of falls reduce the level of frailty in communi- ty-dwelling elderly urban population. 2. Methods 2.1. Study design and participants Enrolment for this prospective interventional study was conducted between January 2015 and September 2017. Study was conducted in city of Rijeka which is an urban environment in 2 Primorje-Gorski Kotar County with a population of some 128,000 of which 19.74\% over 65 years of age and an aging index of 169.8 (data from Croatian Bureau of Statistics). Pilot site Rijeka was 1 of 5 pilot sites included in the project Urban Health Centres Europe (UHCE) for testing preventive integrated health and social care approach for community-dwelling elderly persons. According to last census data, aging index of Rijeka (169.8) is higher than that of state capital Zagreb (111.6) and also Croatia (116.3). According to latest Eurostat data the aging index of 28 members of European Union is 125.8 (data from: https://ec.europa.eu/eurostat). This higher aging index makes Rijeka an especially suitable location for testing interventions aimed at elderly population. However, the same interventions carried here are equally implementable in other urban communi- ties with different ageing indices. This study was approved by the Ethical Committee - Faculty of Medicine University of Rijeka (IRB No:07–04–2014; 2170–24– 01–14–02). All subjects provided informed consent. The study included 410 elderly persons living in their own homes, 283 women and 127 men aged median 80 years (min–max range 75– 95). Inclusion criteria were: age 75 years or older, independent living, expected to be able to participate in the study for at least 6 months according to the assessment of their community nurse. The following exclusion criteria were defined: permanent residence outside the urban community, dementia or psychosis, accommo- dation in an institution for old and helpless persons, persons who are not able to comprehend the basic information on the study or not able to cognitively evaluate the risks and benefits of participation and are not expected to be able to make an informed decision regarding participation in the study. At the beginning of the study frailty, multiple morbidity, polypharmacy, visits to doctors, and the hospitalization of the elderly were evaluated. Upon these data the clinical profile, pathological risk, and residual skills of the elderly were determined. Participants gave their informed consent to participate in the research for the period of 1 year. Before and after the public health intervention programme was conducted the visiting nurses interviewed participants in the control and the intervention group. Physicians, physiatrists, and physiotherapists were involved in the implementation of the public health intervention programme to prevent falls. Along with the visiting nurses, also medical and health professionals of the Department for Social Medicine of the Faculty of Medicine of the University and Rijeka and the Department for Public Health of the Faculty of Health Studies of the University of Rijekaparticipated in the public health intervention to reduce loneliness. 2.2. Measurement Frailty was measured with the Tilburg Frailty Indicator (TFI) questionnaire, which was developed and validated for primary health care use.[32,33] TFI measures physical frailty (including components: perception of physical health, inexplicable weight loss, walking difficulties, difficulty in maintaining balance, hearing impairments, visual impairments, lack of strength in the arms, and physical fatigue), psychological frailty (including components: memory problems, the feeling of being lost, nervous or anxious, inability to deal with problems), and social frailty (including components: perception of life, lack of social relationships, and lack of social support). The independent living analysis is based on measurements with the Groningen Activity Restriction Scale which includes activities of daily living (ADL) items on everyday life activities such as clothing, feeding, https://ec.europa.eu/eurostat Ožić et al. Medicine (2020) 99:8 www.md-journal.com hygiene, and instrumental activities from daily living (IADL). The instrument on everyday life activities essential to maintaining a certain quality of life such as driving, communication manage- ment, financial management, preparing meals, going shopping, and in addition the total restriction of activities /GARS.[34] 2.3. Interventions The public health intervention “fall prevention” consisted of 2 activities: determining and eliminating the risk of falls in the intervention participants home and organized custom exercise twice a week. The nurses at the participants’ home pointed out the risky obstacles in the space, educating the participants about safe movement in old age. Physiotherapists and physiotherapy students designed and maintain custom exercise for elderly at 4 locations in the City of Rijeka. The public health intervention “reducing loneliness” consisted of organized weekly and monthly education and workshops for the elderly, which were also conducted over a period of 1 year. Weekly trainings on “healthy aging” were conducted in cooperation elderly NGOs. Monthly workshops were provided as part of the program activities Healthy City Rijeka. Elderly persons resident in the Western part of the City of Rijeka were included in the intervention groups, and the control group consisted of the elderly resident in the Eastern part of the City of Rijeka. Participants were interviewed at the beginning of the research and participants from the Western part of the city were free to choose and participate in 1 of the 2 interventions according to their preference. 2.4. Statistical analysis Descriptivestatisticsaresummarizedasfrequencies(percentages)for categorical variables. The normality of the distribution of continu- ous variables was tested with the Kolmogorov–Smirnov test. In all cases, median and interquartile ranges were used as central tendency and scattering measures, while nonparametric statistical tests were used to test differences within and between the studied groups of Table 1 Baseline demographic characteristics of subjects. Total sample No interven n (\%) n (\%) Sex Male 127 (31.0) 60 (28.8 Female 283 (69.0) 148 (71.2 Age (median/IQR) 80 (77–84) 81 (78–8 Education Less than high school 175 (42.8) 92 (44.2 High school 190 (46.5) 96 (46.2 College or more 44 (10.8) 20 (9.6) Household income (per month) Less than 2600 HRK ∗ 125 (30.8) 64 (30.9 From 2601 to 3500 HRK 109 (26.8) 56 (27.1 From 3501 to 4500 HRK 64 (15.8) 32 (15.5 From 4501 to 5500 HRK 48 (11.8) 24 (11.6 More than 5500 HRK 60 (14.8) 31 (15.0 Study group No intervention 208 (50.7) Prevention of falls 91 (22.2) Reduction of loneliness 111 (27.1) Variables education had 1 missing value and Household income had 4. ∗ 1 HRK equals approximately 0.15 USD. 3 participants. The McNemar test was used for the differences with regardtothe categoricalvariablesbetweenthe 2meteringpointsand the Wilcoxon test of equivalent pairs was used to compare the other aging parameters between two time points expressed as continuous variables. In the case of statistically significant differences, these differences were additionally examined by the post-hoc Mann– Whitney U test series with Bonferroni correction of the level of statistical significance. Univariate relationship between frailty and independent living was investigated using the Spearman correlation coefficient. Linear multiple regression was used to predict the factors significant for frailty after the interventions. We have scoped a number of large intervention studies in frailty and found that the effect sizes of the interventions (intragroup differences) on total frailty (measured using Tilburg Frailty Indicator [TFI] which we also used in this study) range from Cohen d of 0.5 to 0.6, which is consistent with our hypothesis of small to medium effect size. We have thus taken a conservative estimate of Cohen d of 0.45 (corresponding to small effect size), 2-tailed hypothesis a=0.05 and b=0.80 which resulted in a sample size of 79 subjects per group. We have planned to enrol 158 patients in the control group and 79 patients in each intervention group for a total of 316 subjects in the study. The level of statistical significance was determined at P<.05 (2-tailed). All data were analyzed with the IBM SPSS v23 (Armonk, NY: IBM Corp., USA). 3. Results A total of 410 elderly subjects were included in the study. Among the active elderly persons, 91 (22.2\%) were involved in the public health intervention programme to prevent falls, while 111 (27.1\%) of elderly persons were involved in the intervention programme to prevent loneliness. The control group with inactive elderly persons numbered 208 (50.7\%) subjects. Observing the respondents’ marital status, the first point of measurement showed that most of them were widowers (210/ 410, 51.2\%), followed by married persons (176/41,042, 9\%), persons living in living extramarital relationships (1/410, 0.2\%), singles (11/410, 2.7\%), and divorced (12/410, 2.9\%) (Table 1). tion Prevention of falls Reduction of loneliness n (\%) n (\%) ) 25 (27.5) 42 (37.8) ) 66 (72.5) 69 (62.2) 4) 79 (77–82) 81 (78–85) ) 42 (46.2) 41 (37.3) ) 40 (44.0) 54 (49.1) 9 (9.9) 15 (13.6) ) 33 (36.7) 28 (25.7) ) 20 (22.2) 33 (30.3) ) 13 (14.4) 19 (17.4) ) 12 (13.3) 12 (11.0) ) 12 (13.3) 17 (15.6) http://www.md-journal.com Table 2 Marital status, household, and alcohol use. Baseline End n (\%) n (\%) P Partner Yes 177 (43.2) 154 (37.6) <.001 No 233 (56.8) 256 (62.4) Number of persons in household (median and interquartile range) 2 (1–2) 2 (1–2) .19 Smoking Yes 38 (9.3) 19 (4.6) .001 No 372 (90.7) 391 (95.4) Frequency of alcohol use Never 265 (64.6) 296 (72.2) <.001 At least sometimes 145 (35.4) 114 (27.8) Ožić et al. Medicine (2020) 99:8 Medicine At the beginning of the study there were 38 (9.3\%) smokers, while 145 (35.4\%) of respondents consumed alcohol. At the beginning of the study 177 (43.2\%) of participants had a partner. There was statistically no significant difference between begin- ning and end of study concerning the number of persons living in the household (P=.19). The proportion of smokers between the 2 time points also decreased (P=.001), as well as the proportion of elderly persons who at least occasionally consume alcohol (P<.001) (Table 2). After 1 year, physical frailty measured in the control group showed a statistically significant increase (z=�2.25; P=.024; r=�0.11), while in the intervention groups physical frailty did not increase (both P>.05). Psychological frailty measured after 1 year in the control group was significantly higher (z=�3.87; P<.001; r=�0.19), as well as in the group where the public health interventions to reduce loneliness were carried out (z=� 2.07; P=.039; r=�0.19). Psychological frailty did not increase in the group in which public health interventions to prevent falls were carried out, and social frailty did not increase at all in the study period. The total level of frailty in the control group after 1 year was significantly increased (z=�3.84, P<.001, r=�.19), while no increase was seen in the overall frailty in the intervention groups (Table 3). Table 3 Measurement of total, physical, psychological, and social frailty in study groups at the beginning and end of study. Group Baseline End P Physical frailty No intervention 4 (3–5) 5 (3–6) .024 Prevention of falls 3 (2–5) 3 (2–5) .14 Reduction of loneliness 3 (2–4) 3 (1–4) .49 Psychological frailty No intervention 2 (1–2) 2 (1–3) <.001 Prevention of falls 1 (0–2) 2 (1–3) .06 Reduction of loneliness 1 (0–2) 2 (0–3) .039 Social frailty No intervention 1 (1–2) 1 (1–2) .54 Prevention of falls 0 (1–1) 1 (0–2) .98 Reduction of loneliness 1 (1–2) 1 (1–2) .96 Total frailty No intervention 7 (5–9) 8 (6–10) <.001 Prevention of falls 5 (4–8) 6 (3–8) .80 Reduction of loneliness 6 (3–8) 6 (3–8) .52 Values given as median (interquartile range). 4 When assessing between group differences we compared differences in change of frailty over time and found that the 3 groups differed in the rate of change, that is, physical frailty increased more in the control group than in prevention of falls group (P=.045), while there were no differences among the control group and prevention of loneliness group or between the 2 intervention groups (P=.24 and P>.99, respectively). Additionally, there were no statistically significant between group differences in the rate of change of total, psychological, or social frailty (all P>.05), but total frailty showed a non- significantly higher rate in the control group compared with the 2 intervention groups (P=.08). The analysis of independent living showed that after 1 year in the control group there was a statistically significant increase in ADL values, along with restrictions in daily activities (z=�6.35, P<.001, r=�0.32). The same was observed in the group in which public health interventions to reduce loneliness were carried out (z=�2.51; P=.012; r=�0.17). In the group in which the intervention programme to reduce physical frailty (prevention of falls) was carried out, there was no increase in ADL restriction values after 1 year in the respondents’ daily activities. The IADL measurements relating to the capability of carrying out more complex tasks related to life quality has shown an increase in the IADL restriction values in all 3 of the study groups: the control group (z=�7.52, P<.001, r=�0.37), the group with inter- ventions to reduce loneliness (z=�5.57; P<.001; r=�0.38), and the group with interventions to prevent falls (z=�3.20; P=.001; r=�0.24). In conclusion, the results of the total GARS restrictions showed the highest increase in the control group (z=�7.58; P<.001; r=�0.38), a slightly smaller increase in the group with interventions to reduce loneliness (z=�4.98; P<.001; r=�0.35), and the lowest increase was found in the group with interventions to prevent falls (z=�2.45; P=.014; r=�0.35). In determining the relationship between frailty and independent living in all groups of participants, a statistically significant connection of frailty with both forms of restriction was obtained, ADL and IADL—as well as in the overall result of GARS restrictions. All of these correlations were positive, which means that a higher level of frailty is associated with a higher degree of ADL restrictions in daily activities and IADL complex tasks related with the quality of life (Tables 4 and 5). The variables included in the predictive multivariate model of frailty in the elderly were as follows: demographic characteristics, Table 4 Restrictions in activities of daily living by intervention and time point. Baseline End Median (IQR) Median (IQR) P Activities of daily living (ADL) No intervention 16 (12–22) 19 (14–24) <.001 Prevention of falls 14 (12–20) 15 (12–20) .060 Reduction of loneliness 13 (11–18) 14 (11–19) .012 Instrumental activities from daily living (IADL) No intervention 12 (8–18) 15 (11–21) <.001 Prevention of falls 10 (7–15) 12 (8–19) .001 Reduction of loneliness 9 (7–14) 13 (8–17) <.001 Groningen Activity Restriction Scale (GARS) No intervention 28 (20–40) 33 (25–44) <.001 Prevention of falls 25 (19–35) 28 (19–39) .014 Reduction of loneliness 22 (18–31) 28 (21–37) <.001 Table 5 Correlation between frailty and activities of daily living. Baseline End rS P rS P Activities of daily living (ADL) No intervention 0.62 <.001 0.62 <.001 Prevention of falls 0.48 <.001 0.58 <.001 Reduction of loneliness 0.57 <.001 0.55 <.001 Instrumental activities from daily living (IADL) No intervention 0.57 <.001 0.57 <.001 Prevention of falls 0.47 <.001 0.48 <.001 Reduction of loneliness 0.57 <.001 0.29 .002 Groningen activity restriction scale (GARS) No intervention 0.62 <.001 0.61 <.001 Prevention of falls 0.48 <.001 0.53 <.001 Reduction of loneliness 0.59 <.001 0.42 <.001 rS=Spearman correlation coefficient. Ožić et al. Medicine (2020) 99:8 www.md-journal.com initial level of frailty, public health interventions, quality of life, independent living, and the use of health care. The tested variables explained 56.5\% of the variance in the second time point of measurement (R2=0.565, F=24.91, df1=19, df2= 365, P<.001). Multivariate analysis also shown that both interventions where independently associated with lower end frailty (both P<.05). Additionally, higher baseline frailty and visit to a physician in the last year were positively associated with higher end-study frailty level, while higher number of subjects in the household and higher total psychological quality of life (SF- 12) were independently associated with lower end-study frailty (all P<.05) (Table 6). Total frailty was included in the final regression model due to potential multicollinearity problem if physical, psychological, and social frailty are included separately in one regression model. However, testing this potential model with all 3 dimensions of frailty included showed that it did not Table 6 Multivariate linear regression analysis showing predictors of final/ end study frailty (N=385). B SE (B) b P Baseline frailty 0.28 0.05 0.27 <.001 Female sex 0.12 0.31 0.02 .689 Age 0.00 0.03 0.01 .871 Education �0.36 0.24 �0.06 .138 Marital status 0.11 0.28 0.02 .702 Household income �0.44 0.25 �0.07 .076 Number of persons in household �0.36 0.12 �0.11 .003 Smoking 0.34 0.50 0.02 .499 Alcohol intake 0.21 0.27 0.03 .431 Prevention of falls (intervention) �0.72 0.28 �0.10 .010 Prevention of loneliness �0.56 0.27 �0.08 .039 Total physical quality of life, SF-12 �0.04 0.04 �0.07 .340 Total psychical quality of life, SF-12 �0.16 0.03 �0.32 <.001 Activities of Daily Living, ADL 0.05 0.03 0.12 .107 Instrumental Activities from Daily Living, IADL 0.01 0.04 0.01 .851 Visit to physician in the last year 0.87 0.35 0.09 .014 Need for help in house 0.38 0.37 0.04 .303 Need for help in conducting hygiene �0.86 0.47 �0.08 .070 Hospitalization �0.02 0.31 0.00 .944 b=standardized regression coefficient, B=non-standardized regression coefficient, SE B=standard error of B. 5 improve on the final model with total frailty included (R21 vs R 2 2, 0.541 vs 0.542, respectively). 4. Discussion The study analyzed the physical, psychological, and social nature of frailty in order to get a comprehensive view on the frailty of the elderly, and in order to do so an integrated conceptual model of frailty was implemented. While few well-designed trials were designed specifically to target incidence and characteristics of pre-frailty and frailty in the elderly, some trials have shown success. Frailty Intervention Trial (FIT) which recruited 216 persons and showed that a multifactorial, interdisciplinary approach tailored for each individual subject and targeted specifically to reduce the frailty component present on baseline exam consisting of dietetic evaluation and nutritional intervention, measures to reduce social isolation and physiotherapy and exercise regime significantly reduced frailty in a 12-months period.[35,36] Recent randomized, open label, controlled trial by Serra-Prat et al[37] showed that nutritional assessment and potential intervention and physical intervention consisting of aerobic, strengthening, balance, and coordination exercises are … STUDY PROTOCOL Open Access A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting Ruth McCullagh1*, Eimear O’Connell2, Sarah O’Meara3, Ivan Perry4, Anthony Fitzgerald4, Kieran O’Connor5, N. Frances Horgan6 and Suzanne Timmons1 Abstract Background: Older adults experience functional decline in hospital leading to increased healthcare burden and morbidity. The benefits of augmented exercise in hospital remain uncertain. The aim of this trial is to measure the short and longer-term effects of augmented exercise for older medical in-patients on their physical performance, quality of life and health care utilisation. Design & Methods: Two hundred and twenty older medical patients will be blindly randomly allocated to the intervention or sham groups. Both groups will receive usual care (including routine physiotherapy care) augmented by two daily exercise sessions. The sham group will receive stretching and relaxation exercises while the intervention group will receive tailored strengthening and balance exercises. Differences between groups will be measured at baseline, discharge, and three months. The primary outcome measure will be length of stay. The secondary outcome measures will be healthcare utilisation, activity (accelerometry), physical performance (Short Physical Performance Battery), falls history in hospital and quality of life (EQ-5D-5 L). Discussion: This simple intervention has the potential to transform the outcomes of the older patient in the acute setting. Trial registration: ClinicalTrials.gov Identifier: NCT02463864, registered 26.05.2015. Keywords: Frail, Medical, Inpatients, Exercise, Physiotherapy, Length of stay Background Older medical patients can experience a prolonged acute hospital stay and functional decline In Ireland in 2011, 11.6 \% of the population was aged 65 years and over [1], and this is set to rise to 22 \% by 2041 [2]. Extended periods of poor health are predicted with this longevity [2]. Older patients occupy most acute hospital beds and most frequently experience a prolonged length of stay (of greater than 30 days) [3], functional decline, high re-admission rates, falls, and institutionalisation [4]. Frailty is described as a geriatric syndrome with reduced capacity of the individual to re- sist stress and includes characteristics of slow mobility, low physical activity (PA) and energy levels [5]. Inactivity has been identified as a major determinant in the onset of frailty and exercise has been found to prevent or slow down this decline [6]. Therefore, maintenance of older adults’ functional independence while in hospital is of utmost importance.* Correspondence: [email protected] 1Centre for Gerontology & Rehabilitation, University College Cork, Cork, Ireland Full list of author information is available at the end of the article © 2016 McCullagh et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. McCullagh et al. BMC Geriatrics (2016) 16:79 DOI 10.1186/s12877-016-0252-z http://crossmark.crossref.org/dialog/?doi=10.1186/s12877-016-0252-z&domain=pdf https://clinicaltrials.gov/ct2/show/NCT02463864 mailto:[email protected] http://creativecommons.org/licenses/by/4.0/ http://creativecommons.org/publicdomain/zero/1.0/ Physical activity levels and exercise intervention for medical patients in hospital Recent evidence has shown that older medical patients walk an average of 1534 (±112) steps per day in hospital and that prolonged length of stay was inversely associ- ated with daily step count, even when adjusted for age, gender and physical performance on admission [7]. Simi- larly, Fisher et al. [8] found that older adults, who increase their walking activity by 600 steps on the second day of observation, were discharged home two days earlier. These findings suggest that low physical activity in hos- pital may directly influence length of stay and supports the theory that patients should exercise and remain active in the acute setting. Exercise programmes in hospital have been delivered independently or as a component of a multidisciplinary intervention and have been shown to improve physical performance, quality of life, reduce falls incidence and reduce healthcare utilisation [9–13]. The evidence of effectiveness of augmented exercise in hospital To date, small benefits from augmented exercise on func- tion and healthcare utilisation have been found. A system- atic review found limited benefits from exercise as part of a multidisciplinary service on function, length of stay and dis- charge destination for acutely hospitalised older medical in- patients [14]. Three trials investigated the benefits of add- itional exercise alone [15–17]; none of which showed a sig- nificant improvement on length of stay. The authors suggested that the findings might have been weakened by using inappropriate outcome measures, recruitment of pa- tients who had good baseline physical performance levels, and poor adherence to the exercise intervention that was being prescribed. Rationale for the trial and protocol To date, additional exercise has not been found to shorten frail older patients’ hospital stay but the issues reported by previous authors may have weakened the results. To ad- dress these issues, the proposed protocol differs from previ- ous studies in key parameters. A qualified physiotherapist will deliver and support the exercise sessions. Only patients who are less able to maintain physical activity will be re- cruited; those who need a walking aid and/or physical as- sistance on admission. Those who are unable to walk with assistance will be excluded from the trial. The Short Physical Performance Battery (SPPB) and walking speed will be used to measure physical performance, as these were previously found to be sensitive and appropriate for the study group [13]. The control arm will include sham exer- cises, to control for the considerable increase in patient- physiotherapist contact time. Finally, independent physical activity (usually walking) will be promoted outside the exer- cise sessions, in the intervention group. Therefore, the aim of this study is to measure the ef- fects of an augmented prescribed exercise programme for frail older medical inpatients on their physical per- formance, quality of life and healthcare utilisation. Methods Design and study size The study is a single blind randomised controlled trial set in an acute 350-bedded teaching hospital. Power calcula- tions based on the results of a pilot study indicated that a sample size of 200 (100 patients in each arm) would be re- quired. To allow for an expected attrition rate of 5 \% [18], two hundred and twenty medical patients aged 65 years and over are randomly allocated to either the intervention or sham arm in a ratio of 1:1. (see Fig. 1). The study has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. (ECM 3 (vv) 13/10/15). Selection of participants and allocation All suitable patients are screened and if eligible, are in- formed of the study and written consent is sought. The in- clusion criteria are: medical patients aged 65 and over, who have been admitted from home and initially planned for discharge home, whose anticipated length of stay is greater than 3 days, and who require a mobility aid or assistance to walk. The exclusion criteria are: patients who have been an in-patient for more than 48 h prior to screening, who are unable to follow commands in the English language, unable to exercise with the assistance of one person only, bed or chair-bound at baseline, admitted with an acute psychiatric condition, require active end-of-life or critical care or when exercise is contraindicated. To ensure adequate treatment time is given to each pa- tient, recruitment is paused when there are five patients ac- tive in the trial. Based on the hospital’s usual length of stay, this usually results in one patient recruited each weekday. If more than one patient is eligible for the study on one day, they are approached in chronological order of admission. The patients are randomly allocated to either the inter- vention (APEP) or control group. A computer-generated random allocation sequence is used. Block randomisation is applied (in groups of approximately 50 patients). Post hoc power analysis will be calculated when the first seventy-five patients have completed the trial. Roles of the researchers Randomisation and data entry is completed by the Re- search Assistant (RA, SO’M). Screening, recruitment, base- line measurements and all exercise sessions are completed by the Principal Investigator (PI, RMcC). The discharge and follow-up assessments are completed by the blinded Research Physiotherapist (RPT, EO’C), who has no involve- ment in either the allocation or intervention components of the trial. McCullagh et al. BMC Geriatrics (2016) 16:79 Page 2 of 7 Measurements Patients are assessed within 48 h of admission, at dis- charge and at three months following discharge. The assessment tools are described in Table 1. Baseline data includes demographics, co-morbidity, medication use and home circumstances. Fig. 1 Flowchart with details of the study design and flow of participants McCullagh et al. BMC Geriatrics (2016) 16:79 Page 3 of 7 The primary outcome measure is length of stay, a key healthcare utilisation metric. The secondary outcome mea- sures includes patient-related measures: changes in physical performance (SPPB, walking speed), and quality of life at 3 months following discharge, differences in physical activity levels between groups in hospital (based on accelerometry data) and re-admission rates over three months. The base- line assessment is designed to capture frailty, co-morbidity and disability. Measurements that are appropriate and quick to administer have been chosen to limit patient fatigue. Measurements of Co-morbidity and frailty The Cumulative Illness Rating Scale Geriatrics (CIRS-G) has been chosen as it measures chronic medical illness burden with good reliability and is a validated tool both as an indicator of health status and as a predictor of 18- month mortality and hospitalisation [19]. The CIRS-G has 14 categories, with a 0 to 4 grading system of im- pairment in each organ system. The score may theoretic- ally range from 0 to 56, with a higher score reflecting greater impairment in several systems. To measure frailty, the SHARE-FI [20] tool has been chosen as it is a valid and simple measurement of frailty. Five SHARE variables approximating Fried’s frailty defin- ition are used: fatigue, loss of appetite, grip strength, func- tional difficulties and physical activity. Scores range between 2.7 to 13.4 and the SHARE-FI calculators (gender- specific) are freely available on the web to interpret the level of frailty [20]. The Six-Item Cognitive Impairment Test (6-CIT) will be used to measure cognition as it is quick to administer, its diagnostic accuracy is as high as the Mini-Mental State Examination when used in the acute hospital set- ting, and it is not sensitive to an educational level and does require advanced language skills [21]. Measurements of disability Physical Performance is measured using the Short Phys- ical Performance Battery (SPPB), which includes walking speed [22]. The SPPB has been chosen as it is quick, practical and safe to use with this population. The scores range from 0 (unable to stand independently,) to 12 (in- dependent tandem balance for 10 s, able to walk 4 m within 4.82 s and sit to stand 5 times in 11 s). Walking speed is known to be a strong indicator of patients’ physical performance and is an independent predictor of survival and institutionalisation [23]. All patients scoring less than 1 on the SPPB will be eliminated from the study to allow us to detect functional decline while in hospital. Measurements of well-being, self-efficacy and self- reported functional ability Quality of Life will be measured using the EuroQol 5- Domain 5-Level Scale (EQ-5D-5 L) [24] as it is well- used and easy to administer. The five domains assessed are mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a visual analogue scale, ranging from 0 to 100, to measure self-rated health status [24]. At baseline only, fear of falling is measured using the Falls Efficacy Scale-International (FES-I) [25]. This tool consists of 14 activity-related questions. The questions aim to determine how concerned older adults are about falling while performing these activities on a scale of 0 (not concerned at all) to 4 (very concerned). The Nottingham Extended Activities of Daily Living Scale (N-EADL) [26] is a self-reported tool to measure the patients’ ability to complete 16 community-based ac- tivities. On admission, patients are asked to report their functional ability both pre-morbidly (before the onset of the illness) and on admission (the day before they were admitted) and again, at the three month follow-up as- sessment. Patients can score 0 (unable to complete the Table 1 Summary of the Measurements used in the Study Domain On admission Discharge and 3 months Medical Morbidity Cumulative Illness Rating Scale (CIRS-G [19]); Total number of medications Frailty SHARE- FI [20] Grip Strength (kgs) Physical Performance Short Physical Performance Battery (SPPB) (includes walking speed) [22] SPPB [22] (includes walking speed) Falls Efficacy and Self-Reported Functional Ability Number of Falls and injuries sustained Number of falls and injuries sustained Falls Efficacy Scale – International (FES-I) [25] Nottingham Extended Activities of Daily Living Scale (N-EADL) [26] Nottingham Extended Activities of Daily Living Scale (N-EADL) [26] Cognition 6CIT [21] 6CIT [21] Quality of Life EQ-5D-5 L [24] EQ-5D-5 L [24] Physical Activity Accelerometers (Stepwatch Activity Monitor, SAM) during hospitalisation only McCullagh et al. BMC Geriatrics (2016) 16:79 Page 4 of 7 activity with/without help) or 1 (able to complete the score with/without help). This has been used extensively in older adult populations, including patients with stroke and fallers [27,28]. Measurements of physical activity All patients with good skin condition at the ankle are asked to wear accelerometers (Stepwatch Activity Moni- tors, SAM) to measure physical activity (step-count) in the hospital. These devices have been validated in frail older in-patients and can be worn in the shower, helping compliance and successful data collection [29]. They are capable of storing up to seven days of data without inter- ruption using a 15 s epoch. They are attached on the first day of recruitment and worn continuously while in hospital or for the first seven days. All staff are informed of their application. The accelerometry data will be ana- lysed to measure 1. Changes in activity between groups. 2. Levels of physical activity compared to a recently completed observation study (which assisted in identifying those who were at risk/not at risk of functional decline). Procedure Intervention and routine care schedule Both groups receive usual multidisciplinary care. The med- ical team refer patients to physiotherapy if required. It is delivered, an average of three times weekly, by the clinical ward physiotherapist and will be routine in nature. It con- sists of assessment, discharge planning, exercise, provision of aids and rehabilitation. Both the control and the inter- vention groups also receive two augmented, twenty minute to half-hour exercise sessions (tailored to the patient’s en- durance), five days per week, delivered on a one-to-one basis by the PI. Consent, assessment and exercise procedure Upon screening, the medical team are contacted to con- firm that there is no medical contra-indication to exercise for the patient. Eligible patients are informed of the study verbally and given a copy of the patient information leaflet. They give written informed consent to the study, including access to their medical notes, assessment at baseline, out- come and follow-up, and the twice daily exercise sessions. If the patient is considered to be cognitively impaired by the medical or nursing staff, the patients’ written consent is augmented by verbal assent from their next of kin. Pa- tients with severe confusion, who are unable to follow commands, or are agitated, are not recruited to the study. If recruited, patients are assessed (Time 1), and through concealed allocation, randomly allocated to the control group or the intervention group at that time. All recruited patients, who consent to wearing the accelerometer and with good skin condition at the ankle, are fitted with the SAM to measure physical activity in hospital. For those in the intervention (Augmented Prescribed Ex- ercise Programme, APEP) group, their exercise programme is prescribed to address their physical limitations identified through the assessment. The exercises are chosen to improve strength and balance, core stability, sit-to-stand function, balance (in standing and walking), walking and endurance. The intervention group are also actively encour- aged to mobilise while in hospital, with assistance when ne- cessary, and provided with walking aids initially, if required. The sham exercise sessions for the control group are not prescribed but consist of standardised stretching and relaxation exercises. All exercise sessions begin within 24 h of group alloca- tion and continue until the day before discharge. Verbal consent for each session is sought. To ensure false step-count does not occur, the acceler- ometer (SAM) is turned upside-down (in this position, it is unable to record steps) when the patient is exercising at the bedside, i.e., not walking, and returned to the upright position before walking or at the end of the session. Patient compliance, exercise prescription and session duration is recorded. Within one day of planned dis- charge, all patients are re-assessed and the accelerometer (SAM) is removed from the patient by the RPT (Time 2; see Table 1). Patients who are deemed for long-term care (as they are unable to manage at home) or for end-of- life care are re-assessed on the date that the decision is made and those results are used. The patients are reassessed at three months post dis- charge, by the RPT (Time 3, see Table 1). New onset of illness, physical performance, walking speed, quality of life and self-reported functional ability is measured. Hos- pital and Accident and Emergency utilisation since dis- charge is recorded. Safety, reporting of adverse events and serious adverse events The main adverse events anticipated in this study are skin rashes from the accelerometer, and falls, cardiac ischaemia or pulmonary embolism during exercise. All adverse events are recorded using an adverse event recording work- sheet, and causality to the study intervention is deter- mined, in consultation with the treating physician, by a study physician (KO’C). The Sponsor’s Clinical Research Supporting Officer is notified electronically, within 24 h, of any serious adverse event that occurs during the trial. From a previous local longitudinal study, the Cork De- mentia Study, the in-hospital mortality of this cohort is expected to be approximately two per cent [18]. This pre- dicts approximately 5 deaths of trial subjects. However, the type of exercise involved is similar to usual care, McCullagh et al. BMC Geriatrics (2016) 16:79 Page 5 of 7 patients with a contraindication to exercise will be ex- cluded at source, and patients who are unwell on a par- ticular day will not exercise. Statistical analysis The results will be analysed and presented as recom- mended by the CONSORT guidelines [30]. The primary outcome measure will be length of stay. This will be de- scribed using Kaplan-Meier “survival” curves and the re- sults between groups will be compared using a log-rank test. Univariate and multivariate linear regression ana- lysis will be used to determine differences in physical ac- tivity in hospital and physical performance, quality of life at discharge and three months post-discharge, and re- admission rates at three months. This analysis will help to define whether a simple physiotherapy-led exercise intervention will shorten length of stay, increase physical activity in hospital, limit functional decline and readmission rates and improve quality of life in frail older hospitalised patients. Discussion This study has been designed to measure the effects of an augmented prescribed exercise programme for frail older hospitalised patients. The study design is based upon re- sults of an earlier pilot study and issues reported from previously published studies. Therefore, this protocol dif- fers from previous studies in three key areas: patient selec- tion, intervention and outcome measurements. Previous studies included some patients who were fully independently mobile but de Morton et al. [31] found that the intervention was most effective for those requiring an aid or assistance to walk. For this reason, we will exclude those who are independently mobile. For pragmatic rea- sons, we will also exclude those unable to walk at baseline, i.e., bed or chair bound. There is strong evidence of low physical activity in hos- pital [32, 33] and Broderick et al. [34] found that many of the barriers could be addressed easily. For these reasons, we will not only deliver supervised exercise sessions, but in addition, will encourage mobility while in hospital and provide walking aids initially, if required. The exercises are designed to improve physical performance, transfer func- tion, walking, balance and strength in order to maintain functional mobility as much as possible. Our pilot study [13] showed that there was a consider- able difference in physiotherapy contact time with the intervention, possibly introducing a Hawthorne effect. This has been addressed by using a sham intervention for the control group. To the authors’ knowledge, this is the first time that a sham intervention has been included in this type of study. The intervention will be delivered by a senior physio- therapist. The interventions of previous studies have been delivered by a physiotherapist assistant or a physiotherapy student, under the guidance of a qualified physiotherapist [13,16,17]. However, patients’ physical performance fluc- tuates in the acute setting. If a qualified physiotherapist delivers the programme, it allows the optimal intervention to be delivered on a daily basis. It will also allow a greater opportunity to advise the patient regarding their inde- pendent physical activity in hospital and to address bar- riers to the intervention delivery such as pain relief. Up to 27 \% of the patients were unable to complete the Timed Up and Go Test in previous studies [16,17]. Therefore, the Short Physical Performance Battery will be used, which was found to be feasible and sensitive to change in a previous pilot study [13]. Length of stay will be used as the primary outcome measure as this is available electronically and absolutely complete data. A high attrition rate is predicted for the three-month follow-up attendance as our study group consist of frailer older adults. A small number of studies have shown that interven- tions to increase older medical inpatients’ physical activ- ity can be modestly beneficial. Previous authors discuss issues such as patient selection, intervention type and outcome measures. This protocol has been designed to include the frailer patient, to include a tailored and com- prehensive intervention, and to measure the effects with the most valid outcome measure. Abbreviations 6-CIT: Six-Item Cognitive Impairment Test; APEP: Augmented prescribed exercise programme; CIRS-G: Cumulative Illness Rating Scale – Geriatrics; EQ-5D-5 L: EuroQol 5-Domain 5-Level Scale; FES-I: Falls Efficacy Scale International; N-EADL: Nottingham Extended Activities of Daily Living Scale; PI: Principal Investigator; RA: Research Assistant; RPT: Research Physiotherapist; SAM: Stepwatch Activity Monitor; SHARE-FI: Survey of Health, Aging and Retirement in Europe Frailty Instrument; SPPB: Short Physical Performance Battery. Competing interests The authors declare that there are no conflicts of interest. This study has not received funding or assistance from a commercial organisation. Authors’ contributions RMcC: concept and design, acquisition of subjects and baseline data collection, delivery of the intervention, analysis and interpretation of the data, manuscript preparation. EO’C: outcome data acquisition, manuscript preparation. SO’M patient allocation process, data entry, manuscript preparation. IP: concept and design, manuscript preparation. AF: concept and design, data analysis. KO’C: concept and design, safety monitoring, manuscript preparation. NFH: concept and design, study oversight, manuscript preparation. ST: concept and design, study oversight, analysis and interpretation of the data, manuscript preparation. All authors read and approved the final manuscript. Authors’ details RMcC, Senior Physiotherapist and PhD Student, Centre for Gerontology & Rehabilitation, University College Cork, Ireland. EO’C, Physiotherapist, Physiotherapy Department, Mercy University Hospital, Cork, Ireland. SO’M, Research Assistant, Clinical Research Facility, Mercy University Hospital, Cork, Ireland. IP, Professor of the Dept. of Epidemiology & Public Health, University College Cork, Ireland. AF, Senior Statistician, Dept. of Epidemiology & Public Health, University College Cork, Ireland. KO’C, Consultant Geriatrician, Mercy University Hospital, Cork, Ireland. NFH, Senior Lecturer, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland. ST, Consultant Geriatrician, Mercy University Hospital and Senior Lecturer, Centre for Gerontology & Rehabilitation, University College Cork, Ireland, Ireland. McCullagh et al. BMC Geriatrics (2016) 16:79 Page 6 of 7 Acknowledgements This study is funded by the Health Research Board of Ireland, following a peer- reviewed competition, as a Research Fellowship Training Grant (HPF 2013 451). We would like to thank the Clinical Research Facility and the ward staff at the Mercy University Hospital for facilitating this study. Author details 1Centre for Gerontology & Rehabilitation, University College Cork, Cork, Ireland. 2Physiotherapy Department, Mercy University Hospital, Cork, Ireland. 3Clinical Research Facility, Mercy University Hospital, Cork, Ireland. 4Epidemiology & Public Health, University College Cork, Cork, Ireland. 5Department of Geriatric Medicine, Mercy University Hospital, Cork, Ireland. 6School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland. Received: 24 November 2015 Accepted: 2 April 2016 References 1. CSO: Census 2011 Profile 2 - Older and Younger. In: Central Statistics Office Census 2011 Reports. http://www.cso.ie/en/census/census2011reports/ census2011profile2-olderandyounger/. Accessed 6 March 2016. 2. McGill P: Illustrating Ageing in Ireland North and South: Key Facts and Figures. Belfast: Centre for Ageing Research and Development in Ireland. 2010 3. ESRI: Activity in Acute Public Hospitals in Ireland, Annual Report, 2012. https://www.esri.ie/news/activity-in-acute-public-hospitals-in-ireland-2012- annual-report/. Accessed 6 Mar 2016 4. Covinsky KE, Palmer RM, Fortinsky RH, Counsell SR, Stewart AL, Kresevic D, Burant CJ, Landefeld CS. Loss of independence in activities of daily living in older adults hospitalized with medical illnesses: increased vulnerability with age. J Am Geriatr Soc. 2003;51(4):451–8. 5. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56:M146–156. 6. Boyd CM, Xue QL, Simpson CF, Guralnik JM, Fried LP. Frailty, hospitalization, and progression of disability in a cohort of disabled older women. Am J Med. 2005;118:1225–31. 7. McCullagh R, Dillon C, Horgan NF, Timmons S: Determinants of Prolonged Lenth of Stay and Functional Decline of Older Hospitalised Patients. In: 4th International Conference on Ambulatory Monitoring of Physical Activity and Movement (ICAMPAM): 2015; Limerick. 44. 8. Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010;170(21):1942-3. 9. Jones CT, Lowe AJ, MacGregor L, Brand CA. A randomised controlled trial of an exercise intervention to reduce functional decline and health service utilisation in the hospitalised elderly. Australas J Ageing. 2006;25(3):126–33. 10. Slaets JP, Kauffmann RH, Duivenvoorden HJ, Pelemans W, Schudel WJ. A randomized trial of geriatric liaison intervention in elderly medical inpatients. Psychosom Med. 1997;59(6):585–91. 11. Counsell SR, Holder CM, …
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