On-site Physiotherapy in Older Emergency Department Patients Following a Fall: A Randomized Controlled Trial

doi:10.21203/rs.3.rs-4666400/v1

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On-site Physiotherapy in Older Emergency Department Patients Following a Fall: A Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-4666400/v1

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Purpose: Falls are a frequent cause of emergency department (ED) visits for individuals aged 65 years and older. Greater fear of falling (FOF) is associated with an increased risk of falling in older patients. This study aims to assess the impact of physiotherapy on FOF in older patients and investigates the feasibility of such an intervention in the ED setting.

Methods: All patients aged 65 or older, who presented to the ED of the University Hospital Basel after a fall between January 2022 and June 2023 were screened for inclusion. Participants were assigned to an intervention or control group depending on the randomized presence or absence of a physiotherapist at inclusion.

Results: One hundred four older adults with a recent fall were included (intervention: n = 44, control: n = 60); median age was 81 years and 59.1% were female. There was no between-group difference in FOF as measured by short International Falls Efficacy Scale within a week of inclusion (p = 0.663, effect size = 0.012 [95% confidence interval (CI) - 0.377 to 0.593]). Despite the intervention being deemed feasible from the physiotherapist’s perspective, the study encountered challenges, such as low recruitment and a notable dropout rate.

Conclusion: A physiotherapy intervention in the ED showed no improvement in fear of falling when compared to a control group. Despite concerns about low recruitment and high dropout rates, both groups received a high standard of care, resulting in a reduction in FOF in both groups over the course of the study.

Trial registration number and date: NCT05156944, 01.12.2021

randomized controlled trial

physiotherapy

falls

older

feasibility

emergency department

Aim: This study aims to assess the impact of physiotherapy on fear of falling following a fall in older patients and investigates the feasibility of such an intervention in an emergency department (ED) setting.

Findings: Physiotherapy in the ED did not improve fear of falling in older adults who had presented with a fall compared to a control group. A high standard of care in the ED improved fear of falling in both groups.

Message: With higher fear of falling being associated with an increased risk of falling, the study's findings highlight the significance of a high standard of general care in reducing fear of falling among older adults in the ED, subsequently also reducing the overall fall risk and improving quality of life.

Falls are among the most frequent reasons for presentation to an emergency department (ED) in patients aged 65 years and older. [1] Approximately one third of community-dwelling older adults and nearly one half of institutionalized individuals suffer from a fall each year. [2, 3] Falls are associated with functional decline, social withdrawal, anxiety, depression and an increased use of medical resources. [4] While prevention of falls and ED revisits may be relevant goals [5–8], other, more patient-centered outcomes, such as a reduced fear of falling (FOF), have been identified as research priorities. [9] FOF is common among older adults with falls, and has been associated with reduced physical activity, impaired mobility, decreased performance of activities of daily living, progressive loss of quality of life (QoL), increased rates of institutionalization and an increased risk of falling. [10–15] Furthermore, FOF in older adults presenting to the ED after a fall was linked to poor outcomes at long-term follow-up. [16]

The world guidelines for fall prevention and management strongly (Grade 1B) recommend evaluating for FOF using a standardized instrument such as the Falls Efficacy Scale International (FES-I) or the short FES-I, with a positive screening warranting further risk stratification with gait and balance testing. [17] In addition, the world guidelines for fall prevention and management recommend early referral to physiotherapy for patients at an intermediate or high risk of falling, without providing data for the ED setting. [17] Several studies have suggested that the implementation of physical therapy could be considered feasible in an ED setting. [18, 19] ED-based physical therapy has been associated with a decrease in hospital admissions and fall related ED-revisits. [5, 7, 8] However, there is no RCT published investigating the impact of physiotherapy on FOF in an ED.

Aim of the study

The aim of this RCT was to assess the effect of physiotherapy on FOF in older patients that presented to the ED with a fall within the past 7 days. In addition, we investigated the feasibility of the intervention, improvement in QoL (reduced FOF), objective functional levels for the intervention group at day 7 and patients’ satisfaction with their ED work-up. Furthermore, we measured occurrence of falls and utilization of medical resources throughout the 6-week study period.

Study Design

Our trial was designed as a monocentric, block-randomized, controlled, parallel-group trial. The study protocol was approved by the local Ethics Committee project N° 2021–02165, and the study is registered on the clinicaltrials.gov website (study N° NCT05156944). All patients gave written informed consent before inclusion. Data are presented according to the Consolidated Standards of Reporting Trials Guidelines. [20]

Selection of participants

Patients aged 65 years and older who presented to the ED of the University Hospital Basel between January 2022 and June 2023 and had experienced at least one fall within 7 days of ED presentation were screened for inclusion. A fall was defined as “an event which results in a person coming to rest inadvertently on the ground or floor or other lower level and other than as a consequence of the following: sustaining a violent blow, loss of consciousness, sudden onset of paralysis, or an epileptic seizure”. [21, 22] Exclusion criteria were: admission to hospital after ED work-up (as these patients most likely benefit from physiotherapy during hospital stay), immobilizing fractures of the lower extremities, inability or contraindications to undergo the intervention or follow the study procedures e.g. due to neurological disorders (such as hemiplegia), non-Swiss German speaking, inability to follow instructions or to provide consent due to cognitive impairment, and prior enrolment in this trial. Patients were recruited during weekdays from 8 AM to 5 PM due to the presence of the study physicians.

Randomization

A block-randomization was performed. A physiotherapist (PT) was present in the ED for 50% of the inclusion timeframes (randomized by REDCap), and patients were assigned depending on the presence or absence of a PT. Eligible patients were approached by the study physicians, who were not blinded. Patient blinding was achieved by giving patients written informed consent in the ED without informing them on their allocation and the exact aims of the study. At the first follow-up on day 7, patients were informed on group allocation.

Groups

At presentation, a detailed falls and medical history was taken, and a clinical examination was performed by the ED physician in charge. Where indicated, a further assessment for organic causes, e.g. an electrocardiogram and orthostatic blood pressure was conducted. Blood tests and screening for cognitive impairment [23, 24] were conducted where deemed necessary. A depression and anxiety screening (using the Hospital Anxiety and Depression Scale (HADS), which is a validated screening tool consisting of 14 questions with 7 each for depression and anxiety [25, 26]) was performed on all patients, as was an assessment for frailty using the Clinical Frailty Scale (CFS). [27–29] An evaluation of FOF was done using the sFES-I (which includes questions regarding everyday activities such as getting dressed or undressed, taking a bath or shower, getting in or out of a chair, going up or down stairs, reaching for something overhead or on the ground, walking up or down a slope, and going out to a social event). [30]

Intervention

The intervention in the ED consisted of a physiotherapeutic assessment, the short physical performance battery (SPPB) [31], information on the expected course of the condition and instructions on self-management (e.g. staying active, adaptation of behavior and surroundings at home). Additionally, as recommended in the world guidelines for falls prevention and management [17], a strength exercise (sit-to-stand) and a balance exercise consisting of three difficulty levels (1. Stand behind a chair, feet shoulder-width apart. Try to let go of the chair for 30 seconds; 2. Same as exercise 1 but with feet together; 3. Same as exercise 2 but in a tandem stance) for daily, self-guided therapy were instructed and practiced with the patients. We recommended the patients do these exercises at least 5 times a day, while trying to incorporate them into daily routine activities. In addition, a fall prevention booklet issued by the Swiss Council for Accident Prevention with an activity plan, an exercise description, a checklist on fall hazards at home and fall prevention behavior was handed out. [32] The intervention was conducted at the bedside in the ED examination room and took an average of 23 minutes.

Over the course of the study, two different PTs administered the intervention, one for the first 7 months and the second for the remaining 11 months. Both PTs adhered strictly to the study program. Fall prevention is an integral part of the curriculum of studies in physical therapy, with both PTs being equally qualified.

Control

Patients in the control group were given the same booklet as the intervention group with exercises for daily self-guided therapy, but without an instruction by a PT. No SPPB was performed as no PT was present at inclusion for this group. The control group “intervention” took an average of 2 minutes.

Follow-up

At the first follow-up on day 7, patients in both the control and intervention group received a scheduled, in person consultation by a PT, either at home or at the study site. During this visit, patients were asked for the number of exercises performed and which recommended interventions had been implemented. In addition, objective functional levels were assessed using SPPB, and patients were instructed to answer questionnaires concerning their FOF (sFES-I) and the use of medical resources since inclusion. The follow-ups on day 21 and day 42 consisted of telephone interviews conducted by study physicians using the same questionnaires as on day 0 and 7.

Outcomes

The primary outcome was the difference in FOF between groups at day 7, assessed by sFES-I. The sFES-I was validated and shown to have excellent reliability and construct validity (Cronbach’s alpha 0.92). [30] Cut-offs were defined to differentiate between low, moderate, and high FOF (7–8, 9–13 and 14–28). [33]

Secondary outcomes were the feasibility of the PT intervention as assessed by eligibility, recruitment, loss to follow-up, dropout rates, and a questionnaire (designed by the authors of the study to best assess feasibility from a PT point of view) filled out on the day of inclusion by a PT. Additional outcomes were QoL (relevant sFES-I improvement), objective functional levels in the intervention group, as measured by SPPB at day 7, patients’ satisfaction with their ED work-up (which was assessed using a questionnaire on day 7), the occurrence of falls following randomization from patient recollection, and the use of medical resources.

Statistical Analysis

For the sample size calculation, we considered studies using the FES-I and sFES-I to derive the estimated benefit of our intervention. [34–37] We calculated a necessary population of 64 patients per group to detect a mean difference of 3 points (power = 80%, α = 0.05) with an effect size of 0.5. Based on expert consensus, we defined a priori that a mean difference of 3 points could be deemed clinically meaningful. Assuming a 10% drop out rate or secondary exclusion due to hospitalisation, our study population was set at 70 patients per group, 140 patients total.

An intention-to-treat analysis was conducted. Missing data were handled with available case analysis. The data was tested for normal distribution; a Student’s t test was used for normally distributed data and a Wilcoxon Test for non-normally distributed data. The level of significance was two sided, with a significance level of α = 0.05. The results were corrected for the confounding factors age, sex, and frailty (measured by CFS) using a logistic regression model. All analyses were done using R (Version 4.3.1).

Enrollment and randomization

Of the 1,204 patients screened between January 2022 and June 2023, 1,100 patients were excluded (Figure 1). Nine hundred eighty-three (89.4%) of the exclusions were due to hospital admission or contraindications to undergo the investigated intervention. The remaining 104 patients were randomized into intervention and control groups. Of the 60 patients allocated to the control group, 30 dropped out before the first follow-up (25 were lost to follow-up; 4 patients withdrew their consent, and 1 patient was excluded in a secondary step due to unforeseen hospitalization). Of the 44 patients in the intervention group, 4 were lost to follow-up before the first follow-up, 3 patients withdrew their consent, and 1 patient withdrew due to an intercurrent operation after inclusion. The remaining 30 patients in the control group and 36 patients in the intervention group were analyzed. There were no differences in baseline characteristics between the per protocol and dropout populations.

Baseline characteristics

An overview of the baseline characteristics is shown in Table 1. Median age was 81 years (IQR: 77 – 88) in both groups and 57.7% were female. There was no between-group difference at inclusion for triage level as measured by the Emergency Severity Index (ESI) (p = 0.842), frailty level as measured by CFS (p = 0.324), number of falls in the past 12 months (p = 0.259), mobility (p = 0.349), or pain as measured by numeric rating scale (p = 0.664). With median sFES-I scores of 9.0 in the control group and 10.0 in the intervention group, both groups were in the “moderate concern of falling” category (p = 0.03). Overall, 25.0% of patients took pain medication before inclusion. In the HADS, both groups had median scores within the normal range (0-7 points), indicating no clinically significant depression or anxiety.[26]

Primary outcome

The median sFES-I on day 7 was 10 (IQR 8 – 13) in both the intervention and control group (p = 0.663, effect size = 0.012 [95% confidence interval (CI) - 0.377 to 0.593]) (see Table 2 and Figure 2).

Secondary outcomes

The results of the feasibility questionnaire filled out by the PT are seen in Table 3.

Over the course of the study, the median sFES-I improved in both groups. On the day of inclusion, the median sFES-I was 9 (IQR 7 – 10) in the control group and 10 (IQR 8 – 12) in the intervention group. At the last follow-up on day 42 the median sFES-I was 7 (IQR 7 – 9) in the control group (p < 0.001, effect size = 1.335 [95% CI 0.969 to 1.700]) and 8 (IQR 7 – 9.3) in the intervention group (p < 0.001, effect size = 1.065 [95% CI 0.638 to 1.492]).

The mean SPPB measured in the intervention group at baseline was 6.14, the mean SPPB for the intervention group on day 7 was 7.97 (p = 0.001, effect size = - 0.749 [95 % CI -1.197 to -0.302]) (Table 2). There was no difference in patient satisfaction with their ED work-up (Figure 3).

At the follow-up on day 7, 2 patients in the control group reported a fall (one each) while no patient reported a fall in the intervention group (p = 0.394). At the follow-up on day 21, 1 additional patient reported a fall in each group (p = 1.000). At the follow-up on day 42, 4 additional patients reported a fall in the control group and 2 additional patients reported a fall in the intervention group (p = 0.482).

Concerning the use of medical resources, there was no between-group difference at each of the three follow-ups for ED visits since inclusion, visits to a general practitioner (GP) since inclusion, hospitalization since inclusion, physiotherapy since inclusion or imaging since inclusion. (Table 4).

A multivariable regression analysis for confounding factors age, sex and frailty measured by CFS before inclusion showed that only age had a statistically significant impact on sFES-I score (p = 0.025) at day 7.

Adherence to recommendations

During the first follow-up, adherence to the recommendations (environmental interventions as well as balance and strength exercises) was assessed in both groups by the PT. A higher number of patients in the intervention group followed the recommendations in all cases (Table 5). After removal of non-adherent patients, the median sFES-I was 9 (IQR 8-10) in the control group and 10 (IQR 8-13) in the intervention (p = 0.264, effect size = 0.127 [95% CI - 0.238 to 0.947]).

We observed one serious adverse event in the control group and none in the intervention group. Serious adverse events were defined as medical occurrences that either resulted in death or were life-threatening, required in-patient hospitalization, or resulted in persistent or significant disability or incapacity. In our case, the patient had an injurious fall requiring in-patient hospitalization.

In our RCT of 104 older ED patients presenting after a fall, no difference in FOF was observed between a physiotherapeutic intervention group and a control group 7 days post-inclusion. PT considered the intervention feasible in our ED setting. Patients in both the intervention and control groups showed notable sFES-I improvement six weeks post-inclusion and patients in the intervention group had higher objective functional levels at the first follow-up when compared to the baseline. Despite a higher adherence to recommendations in the intervention group, there was no difference in the occurrence of falls or utilization of resources after 6 weeks.

Our findings concerning FOF differ from the existing literature. A previous RCT indicated a 10% reduction in FOF through a lay-led home-based program, but the participants had higher baseline FOF scores, received frequent visits from trained volunteers, and the controls had no instructions at all. [36] A Canadian study reported FOF improvement after a multifactorial intervention over 6 weeks, supervised by a PT and volunteers, but lacked a control group. [38]

While PT deemed the intervention feasible in our ED setting, a low recruitment and high dropout rate raise questions about the feasibility of such an intervention. In a study assessing ED-based PT and case management services following falls in older adults, only 24.3% of patients were admitted to hospital [7], as opposed to the 54.2% that were admitted over the course of our study. Several studies have tested the feasibility of fall prevention programs and the implementation of physical therapy in an ED setting with recruitment being the main challenge (recruitment rates of 11 – 67% of all eligible patients), even though adherence to recommendations remained high in all studies (88 – 100%). [18, 19, 39, 40] In our cohort, the responsible emergency physicians may have been overly cautious regarding hospitalization.

The notable sFES-I improvement seen in both groups at 6 weeks post inclusion, with no between-group difference, further reinforces the conclusion that FOF was not influenced by the PT intervention. However, patients in the intervention group showed an improvement in objective functional levels, as measured by SPPB, 7 days post-inclusion. A lower SPPB score has been associated with falls in older patients [41, 42] and higher functional levels (higher SPPB score) have been associated with a lower incidence of falling and a lower FOF. [43] Objective functional levels, as measured by e.g. SPPB, may have been a better outcome parameter to judge the effect of on-site physiotherapy in older patients with recent falls, but FOF may be more patient-centered.

In contrast to a recent RCT indicating a significant reduction in fall-related ED revisits with ED-based physiotherapy [5], our study found no differences in ED revisits, GP visits, hospitalizations, number of physiotherapy sessions, or imaging between intervention and control groups. Potential disparities to the aforementioned study may be associated with the relatively good health of our patients (74% using assistive devices in the referenced study, compared to 22.7% in our trial) and the lack of admission as an exclusion criterion in the referenced trial (18.8% admitted after inclusion).

While adherence to recommendations was higher in the intervention group, there is no direct evidence linking adherence to intervention efficacy and fall prevention. [44]

In summary, while the PT intervention did not influence FOF, it did improve adherence to recommendations. Our findings should not fuel “therapeutic nihilism” for falls prevention or hinder future ED-based falls interventions. RCTs favor quantifying efficacy, promoting research in ideal conditions, often inconsistent with actual clinical practice. [45] In our case, ideal “standard-of-care” conditions were granted to both groups, as all patients were provided with a fall prevention booklet with exercises for daily self-guided therapy. This may represent a higher standard of care than usually provided. Over the course of the study, the percentage of patients who attended physiotherapy sessions increased in both groups (20% to 60% in the control group, 22.2% to 58.3% in the intervention group), which may explain the reduction in FOF in both groups without between group differences. Having a similarly high standard of care may benefit all older adults presenting to the ED following a fall.

Limitations

The main limitation of our study was under-recruitment and a high dropout rate despite the intervention being deemed feasible by PT and a high on-site presence of the study physicians (who did not have clinical duties). A cautious hospitalization policy (which may have introduced sampling bias towards more healthy and less frail patients) and stringent exclusion criteria are other possible explanations. Given the moderate FOF at baseline, we hypothesize that patients in the control group may have been less motivated to further participate in the study. Furthermore, due to a limited budget, recruitment had to be stopped before reaching the calculated group size of 70 each, increasing the risk of a Type II error.

Moreover, an increase in physiotherapy visits in both groups over the course of the study suggests potential contamination bias from physiotherapy referrals by GPs.

Possible unmeasured confounders that may have influenced our results include medications that increase fall risk, fall etiology and the number of previous injurious falls. In addition, recall bias may have limited the quality of data about falls before and after randomization. [46]

The generalisability of our findings may be limited by the fact that this study was conducted in a Swiss ED in a tertiary care center with a study population mainly consisting of patients of European descent. In addition, Switzerland has a well-funded healthcare system, and we speculate that the Swiss population may have very high health expectations and high health literacy, and therefore a low threshold for presentation, as well as a low threshold regarding access to medical resources, such as physiotherapy.

Research has shown that physical therapy reduces length of stay in hospital and improves functional outcomes. [47, 48] The inclusion/exclusion criteria, linked with the 42-day follow-up period, pose significant obstacles to participation and therefore accessing physiotherapy.

The small effect size in our intervention can be used for planning future studies. However, a recalculation of sample size based on this effect size showed that tens of thousands of patients per group would have to be included for a significant difference between the intervention and the admittedly high standard of care. However, our sample size of 104 patients is sufficient for a pilot study of exploratory character. [49]

Fear of falling (FOF) is common among older adults following a fall and has been associated with impaired mobility, increased risk of falling, and progressive loss of QoL. An individually adjusted physiotherapy intervention in the ED showed no improvement in short-term FOF as measured by sFES-I, when compared to a control group. While low recruitment and high dropout rates raise questions about the feasibility of such an intervention in an ED setting, the high standard of care and the high use of physiotherapy post ED led to a reduction in FOF in both groups over the course of the study.

PT, physiotherapist; FOF, fear of falling; QoL, quality of life; HADS, hospital depression and anxiety scale; CFS, clinical frailty scale; sFES-I, short falls efficacy scale international; SPPB, short physical performance battery

Declaration of interest: The authors have no relevant financial or non-financial interests to disclose.

Funding/Support: This study was supported by the Scientific Funds of the Emergency Department of the University Hospital Basel [grant number FO 112801].The funding agency had no role in the design and conduct of the study; the collection, management, analysis, or interpretation of the data; the preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Author contributions:

Conceptualization and Methodology: Guido Perrot, Thomas Dreher-Hummel, Barbara Gubler-Gut, Ana García-Martínez, Roland Bingisser, Christian H. Nickel

Formal analysis and investigation: Tanguy Espejo, Henk B. Riedel, Jan-Arie Overberg, Joris Kirchberger, Jonathan Benhamou;

Writing - original draft preparation: Jonathan Benhamou

Writing - review and editing: Jonathan Benhamou, Tanguy Espejo, Henk B. Riedel, Thomas Dreher-Hummel, Ana García-Martínez, Barbara Gubler-Gut, Guido Perrot, Joris Kirchberger, Jan-Arie Overberg, Roland Bingisser, Christian H. Nickel

Funding acquisition, resources and supervision: Roland Bingisser, Christian H. Nickel

Ethical approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the local ethics committee (N° 2021-02165, 07.12.2021)

Consent to participate: Informed consent was obtained from all individual participants included in the study.

Owens PL, Russo CA, Spector W, Mutter R. Emergency Department Visits for Injurious Falls among the Elderly, 2006. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006.
Salari N, Darvishi N, Ahmadipanah M, Shohaimi S, Mohammadi M. Global prevalence of falls in the older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2022;17(1):334;doi:10.1186/s13018-022-03222-1.
Tinetti M, al. e. Risk Factors for Falls Among Elderly Persons Living in the Community. NEJM. 1988;319:1701-7.
Tinetti ME, Williams CS. The Effect of Falls and Fall Injuries on Functioning in Community-Dwelling Older Persons. Journal of Gerontology. 1998;53A:M112-M9.
Goldberg EM, Marks SJ, Resnik LJ, Long S, Mellott H, Merchant RC. Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial. Ann Emerg Med. 2020;76(6):739-50;doi:10.1016/j.annemergmed.2020.07.025.
Close J, Ellis M, Hooper R, Glucksman E, Jackson S, Swift C. Prevention of falls in the elderly trial (PROFET): a randomised controlled trial. Lancet. 1999;353(9147):93-7;doi:10.1016/S0140-6736(98)06119-4.
Gurley KL, Blodgett MS, Burke R, Shapiro NI, Edlow JA, Grossman SA. The utility of emergency department physical therapy and case management consultation in reducing hospital admissions. J Am Coll Emerg Physicians Open. 2020;1(5):880-6;doi:10.1002/emp2.12075.
Lesser A, Israni J, Kent T, Ko KJ. Association Between Physical Therapy in the Emergency Department and Emergency Department Revisits for Older Adult Fallers: A Nationally Representative Analysis. J Am Geriatr Soc. 2018;66(11):2205-12;doi:10.1111/jgs.15469.
Hammouda N, Carpenter CR, Hung WW, Lesser A, Nyamu S, Liu S, et al. Moving the needle on fall prevention: A Geriatric Emergency Care Applied Research (GEAR) Network scoping review and consensus statement. Acad Emerg Med. 2021;28(11):1214-27;doi:10.1111/acem.14279.
Scheffer AC, Schuurmans MJ, van Dijk N, van der Hooft T, de Rooij SE. Fear of falling: measurement strategy, prevalence, risk factors and consequences among older persons. Age Ageing. 2008;37(1):19-24;doi:10.1093/ageing/afm169.
Hill K, Womer M, Russell M, Blackberry I, McGann A. Fear of falling in older fallers presenting at emergency departments. J Adv Nurs. 2010;66(8):1769-79;doi:10.1111/j.1365-2648.2010.05356.x.
Lanoue MP, Sirois MJ, Perry JJ, Lee J, Daoust R, Worster A, et al. Fear of falling in community-dwelling older adults presenting to the emergency department for minor injuries: Impact on return to the ED and future falls. CJEM. 2020;22(5):692-700;doi:10.1017/cem.2020.383.
Cumming RG, Salkeld G, Thomas M, Szonyi G. Prospective study of the impact of fear of falling on activities of daily living, SF-36 scores, and nursing home admission. J Gerontol A Biol Sci Med Sci. 2000;55(5):M299-305;doi:10.1093/gerona/55.5.m299.
Li F, Fisher KJ, Harmer P, McAuley E, Wilson NL. Fear of falling in elderly persons: association with falls, functional ability, and quality of life. J Gerontol B Psychol Sci Soc Sci. 2003;58(5):P283-90;doi:10.1093/geronb/58.5.p283.
Delbaere K, Crombez G, Vanderstraeten G, Willems T, Cambier D. Fear-related avoidance of activities, falls and physical frailty. A prospective community-based cohort study. Age Ageing. 2004;33(4):368-73;doi:10.1093/ageing/afh106.
García-Martínez A, García-Rosa S, Gil-Rodrigo A, Machado VT, Pérez-Fonseca C, Nickel CH, et al. Prevalence and outcomes of fear of falling in older adults with falls at the emergency department: a multicentric observational study. European Geriatric Medicine. 2024;doi:10.1007/s41999-024-00992-1.
Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, Ryg J, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age Ageing. 2022;51(9);doi:10.1093/ageing/afac205.
Goldberg EM, Marks SJ, Ilegbusi A, Resnik L, Strauss DH, Merchant RC. GAPcare: The Geriatric Acute and Post-Acute Fall Prevention Intervention in the Emergency Department: Preliminary Data. J Am Geriatr Soc. 2020;68(1):198-206;doi:10.1111/jgs.16210.
Tousignant-Laflamme Y, Beaudoin AM, Renaud AM, Lauzon S, Charest-Bosse MC, Leblanc L, et al. Adding physical therapy services in the emergency department to prevent immobilization syndrome - a feasibility study in a university hospital. BMC Emerg Med. 2015;15:35;doi:10.1186/s12873-015-0062-1.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18;doi:10.1186/1741-7015-8-18.
World Health Organization. Step Safely: Strategies for Preventing and Managing Falls across the Life-Course. 2021.
Kellog International Work Group. The Prevention of Falls in Later Life. Dan Med Bull. 1987;34:1-24.
Hasemann W, Grossmann FF, Stadler R, Bingisser R, Breil D, Hafner M, et al. Screening and detection of delirium in older ED patients: performance of the modified Confusion Assessment Method for the Emergency Department (mCAM-ED). A two-step tool. Intern Emerg Med. 2018;13(6):915-22;doi:10.1007/s11739-017-1781-y.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-9;doi:10.1111/j.1532-5415.2005.53221.x.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69-77;doi:10.1016/s0022-3999(01)00296-3.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361-70;doi:10.1111/j.1600-0447.1983.tb09716.x.
Nickel CH, Kellett J. Assessing Physiologic Reserve and Frailty in the Older Emergency Department Patient: Should the Paradigm Change? Clin Geriatr Med. 2023;39(4):475-89;doi:10.1016/j.cger.2023.05.004.
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, et al. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005;173(5):489-95;doi:10.1503/cmaj.050051.
Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, et al. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022;29(5):572-80;doi:10.1111/acem.14460.
Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, et al. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008;37(1):45-50;doi:10.1093/ageing/afm157.
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49(2):M85-94;doi:10.1093/geronj/49.2.m85.
Beratungsstelle für Unfallverhütung. Selbstständig bis ins hohe Alter. Wohnen, sich bewegen, mobil bleiben. [Available from: https://www.bfu.ch/de/ratgeber/zuhause-sturzsicher-einrichten.
Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010;39(2):210-6;doi:10.1093/ageing/afp225.
Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, De la Torre-Cruz MJ, Jimenez-Garcia JD, Zagalaz-Anula N, et al. Effects of Pilates on fall risk factors in community-dwelling elderly women: A randomized, controlled trial. Eur J Sport Sci. 2019;19(10):1386-94;doi:10.1080/17461391.2019.1595739.
Fisken AL, Waters DL, Hing WA, Steele M, Keogh JW. Comparative effects of 2 aqua exercise programs on physical function, balance, and perceived quality of life in older adults with osteoarthritis. J Geriatr Phys Ther. 2015;38(1):17-27;doi:10.1519/JPT.0000000000000019.
Kapan A, Luger E, Haider S, Titze S, Schindler K, Lackinger C, et al. Fear of falling reduced by a lay led home-based program in frail community-dwelling older adults: A randomised controlled trial. Arch Gerontol Geriatr. 2017;68:25-32;doi:10.1016/j.archger.2016.08.009.
Mat S, Ng CT, Tan PJ, Ramli N, Fadzli F, Rozalli FI, et al. Effect of Modified Otago Exercises on Postural Balance, Fear of Falling, and Fall Risk in Older Fallers With Knee Osteoarthritis and Impaired Gait and Balance: A Secondary Analysis. PM R. 2018;10(3):254-62;doi:10.1016/j.pmrj.2017.08.405.
Begin D, Janecek M, Macedo LG, Richardson J, Wojkowski S. The relationship between fear of falling and functional ability following a multi-component fall prevention program: an analysis of clinical data. Physiother Theory Pract. 2022:1-12;doi:10.1080/09593985.2022.2137384.
Conneely M, Leahy S, O'Connor M, Corey G, Gabr A, Saleh A, et al. A Physiotherapy-Led Transition to Home Intervention for Older Adults Following Emergency Department Discharge: A Pilot Feasibility Randomised Controlled Trial (ED PLUS). Clinical Interventions in Aging. 2023;Volume 18:1769-88;doi:10.2147/cia.S413961.
Hepkema BW, Koster L, Geleijn E, E VDE, Tahir L, Oste J, et al. Feasibility of a new multifactorial fall prevention assessment and personalized intervention among older people recently discharged from the emergency department. PLoS One. 2022;17(6):e0268682;doi:10.1371/journal.pone.0268682.
Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, et al. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019;31(10):1435-42;doi:10.1007/s40520-018-1082-y.
Welch SA, Ward RE, Beauchamp MK, Leveille SG, Travison T, Bean JF. The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients. J Am Med Dir Assoc. 2021;22(8):1646-51;doi:10.1016/j.jamda.2020.09.038.
Halaweh H, Willen C, Grimby-Ekman A, Svantesson U. Physical functioning and fall-related efficacy among community-dwelling elderly people. European Journal of Physiotherapy. 2015;18(1):11-7;doi:10.3109/21679169.2015.1087591.
Simek EM, McPhate L, Haines TP. Adherence to and efficacy of home exercise programs to prevent falls: a systematic review and meta-analysis of the impact of exercise program characteristics. Prev Med. 2012;55(4):262-75;doi:10.1016/j.ypmed.2012.07.007.
Carpenter CR, Malone ML. Avoiding Therapeutic Nihilism from Complex Geriatric Intervention "Negative" Trials: STRIDE Lessons. J Am Geriatr Soc. 2020;68(12):2752-6;doi:10.1111/jgs.16887.
Hoffman GJ, Ha J, Alexander NB, Langa KM, Tinetti M, Min LC. Underreporting of Fall Injuries of Older Adults: Implications for Wellness Visit Fall Risk Screening. J Am Geriatr Soc. 2018;66(6):1195-200;doi:10.1111/jgs.15360.
Hartley PJ, Keevil VL, Alushi L, Charles RL, Conroy EB, Costello PM, et al. Earlier Physical Therapy Input Is Associated With a Reduced Length of Hospital Stay and Reduced Care Needs on Discharge in Frail Older Inpatients: An Observational Study. J Geriatr Phys Ther. 2019;42(2):E7-E14;doi:10.1519/JPT.0000000000000134.
Peiris CL, Taylor NF, Shields N. Extra physical therapy reduces patient length of stay and improves functional outcomes and quality of life in people with acute or subacute conditions: a systematic review. Arch Phys Med Rehabil. 2011;92(9):1490-500;doi:10.1016/j.apmr.2011.04.005.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25(3):1057-73;doi:10.1177/0962280215588241.

Table 1 Baseline characteristics at inclusion

	Overall (N=104)	Control (N=60)	Intervention (N=44)
Age in years, median (IQR)	81 (77 - 88)	81 (76 - 87)	81 (76 - 88)
Female sex, n (%)	60 (57.7)	36 (60.0)	24 (54.5)
ESI, n (%)
1	3 (2.9)	1 (1.7)	2 (4.5)
2	10 (9.6)	6 (10.0)	4 (9.1)
3	80 (76.9)	47 (78.3)	33 (75.0)
4	11 (10.6)	6 (10.0)	5 (11.4)
CFS, n (%)
1	1 (1.0)	0 (0)	1 (2.3)
2	9 (8.6)	5 (8.3)	4 (9.1)
3	36 (34.6)	23 (38.3)	13 (29.5)
4	21 (20.2)	9 (15.0)	12 (27.3)
5	14 (13.5)	7 (11.8)	7 (15.9)
6	15 (14.4)	11 (18.3)	4 (9.1)
Missing	8 (7.7)	5 (8.3)	3 (6.8)
BMI (kg / m²), median (IQR)	24 (22 - 28)	24 (21 - 28)	25 (22 - 27)
Pain medication before inclusion, n (%)	26 (25.0)	18 (30.0)	8 (18.2)
NRS Pain Score, median (IQR)	2.0 (0 - 5.0)	2.0 (0 - 5.0)	1.5 (0 - 5.0)
Mobility, n (%)
Independent	72 (69.2)	36 (60.0)	36 (81.8)
Use of a cane or walking stick	14 (13.5)	11 (18.3)	3 (6.8)
Use of two canes or a walker	18 (17.3)	13 (21.7)	5 (11.4)
Weekly physical activity (minutes), median (IQR)	180 (60 - 360)	120 (30 - 360)	210 (68 - 420)
Fall in the past 12 months, n (%)	44 (42.3)	28 (46.7)	16 (36.4)
Number of falls in the past 12 months, median (IQR)	0 (0 – 1.0)	0 (0 – 1.0)	0 (0 – 1.0)
HADS Anxiety (day 0), median (IQR)	2.0 (1.0 – 4.0)	1.0 (0.0 – 2.0)	3.0 (2.0 – 5.0)
HADS Depression (day 0), median (IQR)	3.0 (1.0 – 5.0)	2.0 (1.0 – 4.0)	4.0 (2.0 – 6.3)
Short FES-I (day 0), median (IQR)	9.0 (8.0 - 11)	9.0 (7.0 - 10)	10 (8.0 - 12)

IQR = interquartile range, ESI = emergency severity index, CFS = clinical frailty score, BMI = body mass index, NRS = numeric rating scale, HADS = hospital anxiety and depression scale, FES-I = falls efficacy scale – international

Table 2 Outcomes at day 7 after inclusion

	Overall (N=66)	Control (N=30)	Intervention (N=36)	P-value
Drop out/Loss to follow up, n (%)	38 (36.5)	30 (50.0)	8 (18.2)
Death, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Location of follow up, n (%)				0.886
Hospital	26 (39.4)	11 (36.7)	15 (41.7)
Home	38 (57.6)	18 (60.0)	20 (55.5)
Missing	2 (3.0)	1 (3.3)	1 (2.8)
Falls since inclusion, n (%)	2 (3.0)	2 (6.7)	0 (0)	0.394
Pain medication since inclusion, n (%)				0.628
No	43 (65.2)	21 (70.0)	22 (61.1)
Yes	22 (33.3)	9 (30.0)	13 (36.1)
Missing	1 (1.5)	0 (0.0)	1 (2.8)
NRS Pain Score, median (IQR)	2.0 (0 - 5.0)	0 (0 - 5.0)	3.0 (0 - 5.8)	0.109
Short FES-I (day 7), median (IQR)	10 (8.0 - 13)	10 (8.0 - 13)	10 (8.0 - 13)	0.663
SPPB (day 7), median (IQR)	8.0 (6.0 – 10)	8.0 (4.3 – 10)	8.0 (7.0 – 9.0)	0.636

Abbreviations: IQR = interquartile range, NRS = numeric rating scale, FES-I = falls efficacy scale – international, SPPB = short physical performance battery

Table 3 Feasibility of the intervention on day of inclusion from the PT’s point of view

	Intervention (N=36)
Missing values, n (%)	2 (5.6)
Number of interruptions during the intervention, n (%)
0	17 (47.2)
1	14 (38.9)
2	2 (5.6)
3	1 (2.7)
Could the patient’s medical needs be met using the standardized physical therapy approach? *, median (IQR)	5.0 (5.0 - 6.0)
*Could the patient’s psychosocial needs be met using the standardized physiotherapy approach? ,** median (IQR)	5.0 (5.0 - 6.0)
*Was the patient open to a physiotherapeutic intervention in the ED? ,** median (IQR)	6.0 (5.0 - 6.0)
Did disturbances in the organizational integration (planning patients, interruptions, transfers within the emergency center, noise, or chaos) of the physiotherapy intervention in the emergency center occur from the perspective of physiotherapy? *, median (IQR)	1.0 (1.0 - 2.0)
Does a physiotherapeutic intervention in this case at this point in time make sense from a physiotherapeutic perspective? *, median (IQR)	5.0 (4.0 - 6.0)
*Did the interprofessional collaboration from the physiotherapy perspective regarding the exchange of information work? ,** median (IQR)	5.5 (5.0 - 6.0)
*On a scale of 1 (= no) to 6 (= yes)

Abbreviations: IQR = interquartile range

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Editorial decision: Major revisions
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On-site Physiotherapy in Older Emergency Department Patients Following a Fall: A Randomized Controlled Trial

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