Dataset Information

Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study.

ABSTRACT:

Background/objectives

In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.

Design

Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.

Setting

A total of 86 primary care practices within 10 U.S. healthcare systems.

Participants

A random subsample of 743 persons aged 75 and older.

Measurements

The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.

Results

Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.

Conclusions

STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

SUBMITTER: Gill TM

PROVIDER: S-EPMC8178516 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFalls are common in older adults and can lead to severe injuries. The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial cluster-randomized 86 primary care practices across 10 health systems to a multifactorial intervention to prevent fall injuries, delivered by registered nurses trained as falls care managers, or enhanced usual care. STRIDE enrolled 5451 community-dwelling older adults age ≥70 at increased fall injury risk.MethodsWe assessed fall-related outcomes via telephone interviews of participants (or proxies) every 4 months. At baseline, 12 and 24 months, we assessed health-related quality of life (HRQOL) using the EQ-5D-5L and EQ-VAS. We used Poisson models to assess intervention effects on falls, fall-related fractures, fall injuries leading to hospital admission, and fall injuries leading to medical attention. We used hierarchical longitudinal linear models to assess HRQOL.ResultsFor recurrent event models, intervention versus control incidence rate ratios were 0.97 (95% confidence interval [CI], 0.93-1.00; p = 0.048) for falls, 0.93 (95% CI, 0.80-1.08; p = 0.337) for self-reported fractures, 0.89 (95% CI, 0.73-1.07; p = 0.205) for adjudicated fractures, 0.91 (95% CI, 0.77-1.07; p = 0.263) for falls leading to hospital admission, and 0.97 (95% CI, 0.89-1.06; p = 0.477) for falls leading to medical attention. Similar effect sizes (non-significant) were obtained for dichotomous outcomes (e.g., participants with ≥1 events). The difference in least square mean change over time in EQ-5D-5L (intervention minus control) was 0.009 (95% CI, -0.002 to 0.019; p = 0.106) at 12 months and 0.005 (95% CI, -0.006 to 0.015; p = 0.384) at 24 months.ConclusionsAcross a standard set of outcomes typically reported in fall prevention studies, we observed modest improvements, one of which was statistically significant. Future work should focus on patient-, practice-, and organization-level operational strategies to increase the real-world effectiveness of interventions, and improving the ability to detect small but potentially meaningful clinical effects.Clinicaltrialsgov identifier: NCT02475850.

Project description:Evidence-based multifactorial fall prevention interventions in clinical practice have been less effective than expected. One plausible reason is that older adults' engagement in fall prevention care is suboptimal. This was a post-hoc analysis of 2403 older adults' engagement in a multifactorial fall prevention intervention in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) pragmatic trial. Based on the direct clinical care level of the Patient and Family Continuum of Engagement (CE) framework, three indicators of progressively interactive engagement were assessed: (1) Consultation (receiving information), (2) Involvement (prioritizing risks), and (3) Partnership (identifying prevention actions). Drop off at each step was determined as well as predictors of engagement. The participants' engagement waned with increasingly interactive CE domains. Although all participants received information about their positive fall risk factors (consultation) and most (51%-96%) prioritized them (involvement), fewer participants (33%-55%) identified fall prevention actions (partnership) for most of their risk factors, except for strength gait or balance problems (95%). More participants (70%) identified home exercises than other actions. Finally, fall prevention actions were identified more commonly among participants who received two visits compared to one (OR = 2.33 [95% CI, 2.06-2.64]), were ≥80 years old (OR = 1.83 [95% CI, 1.51-2.23]), and had fewer fall risk factors (OR = 0.90 [95% CI, 0.83-0.99]). The drop-off in participants' engagement based on the level of their interaction with clinicians suggests that future multifactorial fall prevention interventions need to be more focused on interactive patient-clinician partnerships that help older adults increase and maintain fall prevention actions. Our analyses suggest that more frequent contact with clinicians and more monitoring of the implementation and outcomes of Fall Prevention Care Plans could potentially improve engagement and help older adults maintain fall prevention actions.

Project description:Background and importanceFalls among older people occur frequently and are a leading cause of Emergency department (ED) admissions, disability, death and rising health care costs. Multifactorial fall prevention programs that are aimed to target the population at risk have shown to effectively reduce the rate of falling and fall-related injuries in community-dwelling older people. However, the participation of and adherence to these programs in real life situation is generally low.ObjectiveTo test the feasibility of a transitionally organized fall prevention assessment with accompanying personalized intervention initiated at the ED.Design, settings and participantsA process evaluation, of a non-randomized controlled pilot trial for implementing a transitionally organized multifactorial fall prevention intervention, was performed using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to gain insight into the barriers and facilitators of implementation. Older fallers (>70yrs) presenting at the ED were selected based on ZIP-code and after obtaining informed consent, data for the evaluation was collected through questionnaires and interviews. Furthermore, feedback was collected from the healthcare providers.Main resultsThe consent was obtained by 24 (70%) of the patients approached directly at the ED and 17 (26%) of the patients approached later by phone. Adherence to the protocol by the participants, clinical assessors and family practice were all more than 90%. After three months, nine (26%) of the participants had at least one recurrent fall: three (20%) patients in the intervention group and six (32%) in the control group.ConclusionED presentation due to a fall in older persons provides a window of opportunity for optimizing adherence to a multifactorial fall prevention program as willingness to participate was higher when the patients were approached at the ED during their stay. Implementing a transitionally organized multidisciplinary fall prevention program was successful with a high protocol adherence.The netherlands trial registerNTR NL8142, November 8, 2019.

Project description:BackgroundThis paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an "as-needed" basis.MethodsSTRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant's underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant's primary care provider. STRIDE's primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be "serious" (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant's self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed.DiscussionAdjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources.Trial registrationClinicalTrials.gov (NCT02475850).