Implementing a Hospital-Based Walking Program (STRIDE): Function QUERI 2.0

Study Overview
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Brief Summary
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Implementing a Hospital-Based Walking Program (STRIDE): Function QUERI 2.0 aims to compare implementation strategies for large-scale spread of STRIDE, a supervised walking program for hospitalized older Veterans. The overall goal is to implement, evaluate, and sustain STRIDE in 32 additional VA hospitals using a type III effectiveness-implementation hybrid design framework.

Detailed Description
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Background/Purpose. Hospitalization is a major risk factor for development of disability. More than one-third of adults over the age of 70 are discharged from the hospital with a major new disability that was not present before the onset of acute illness. A key contributor to hospital-associated disability is immobility during hospitalization. Although fewer than 5% of patients have physician orders for bed rest, hospitalized older adults spend only about 3% of their time standing or walking. The hazards of bedrest have been recognized for more than 2 decades, but there remains a persistent 'epidemic of immobility' in American hospitals. STRIDE is a supervised inpatient walking program developed by an interdisciplinary team of investigators, clinicians and administrators at the Durham VA and funded by the VHA Office of Geriatrics and Extended Care. STRIDE is designed for patients aged >= 60 years and consists of a one-time gait and balance assessment, followed by daily walks supervised by a mobility assistant for the duration of the hospital stay. Clinical demonstration of STRIDE conducted at the Durham VA resulted in a greater likelihood of discharge to home than to skilled nursing or rehabilitation among STRIDE participants compared to clinically similar patients receiving usual care. Based on this experience, the cumulative evidence of the positive impact of early mobility interventions, and successful spread to other hospitals, STRIDE has the potential to become a system-wide approach to address hospital-associated disability in VA. As part of Implementing a Hospital-Based Walking Program (STRIDE), the investigators plan to implement the STRIDE clinical program at an additional 32 VA hospitals using a type III effectiveness-implementation hybrid design framework with hospitals enrolled and randomized to receive low-touch implementation support (foundational support) or a higher-intensity implementation support (enhanced support including additional facilitation, self-organization, and team building support) for hospitals that do not meet program benchmarks at 6 and 8 months. Objectives. The investigators plan to develop scalable approaches to implement and sustain STRIDE as well as evaluate implementation with foundational support versus the enhanced-implementation strategy (enhanced support). Key questions: How should the STRIDE clinical program be adapted to optimize sustainability? Are there differences in implementation outcomes (penetration, fidelity) at 10 months (primary), 13, 16 months between arms? How do hospitals experience implementation strategies in each arm? What baseline organizational characteristics are associated with hospitals that do not meet implementation benchmarks? The investigators also plan to conduct an explanatory sequential mixed method design that includes qualitative data collection and analysis that will not be reported here. Additionally, adoption will be examined at 10 months. Methodology. To evaluate implementation, the investigators will randomize hospitals (n=32) 1:1 to either foundational support or enhanced support. The investigators will use generalized linear models to examine the effect of foundational vs. enhanced on implementation outcomes at 10-months.

Official Title
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Implementing a Hospital-Based Walking Program (STRIDE): Function QUERI 2.0 (QUE 20-023)

Conditions
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Early Ambulation

Intervention / Treatment
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* Other: Implementation Strategy: Foundational Support
* Other: Implementation Strategy: Enhanced Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital inclusion criteria includes submission of a signed participation agreement. All enrolled hospitals will all be exposed to Foundational Support. Hospitals randomized to Enhanced Support that do not meeting STRIDE initial program benchmarks will receive higher-intensity implementation support (Enhanced Support). The clinical outcomes assessment will include all patients >=60 that have an admission on a general medicine ward that offers STRIDE program at enrolled site. Exclusion Criteria: The eight STRIDE hospitals that have previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03300336) will be excluded from enrollment in this study.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA hospitals) are randomly assigned to two interventions: Foundational support (active comparator) vs. Enhanced support (experimental).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foundational Support<br>Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: STRIDE Toolkit; Online shared resources (SharePoint) access for clinical program training materials; Data dashboard to assist hospitals with tracking their own data; Diffusion Networks to promote peer-to-peer sharing and implementation support; and Microsoft TEAMS Channels. | Other: Implementation Strategy: Foundational Support<br>* The goal is to test implementation intensification approaches for STRIDE hospitals that have not met implementation program benchmarks, specifically Foundational Support vs. Enhanced Support. We propose that low intensity implementation support that promotes adapting STRIDE for context and provides tools for ongoing STRIDE evaluation (defined as foundational support), will be sufficient for some but not all hospitals to successfully incorporate STRIDE into routine practice.<br>* Other names: Foundational REP;|
| Experimental: Enhanced Support<br>Enhanced Support begins with the same activities as Foundational Support. Hospitals that are randomized to Enhanced Support and do not meet STRIDE initial program benchmarks within 6 months will continue with Foundational support and also receive higher intensity support for a period of 4-6 months. Hospitals that have sustained their implementation will continue low-touch activities while those that have been randomized to the enhanced support arm and met the initial program benchmark at 6-months but have not sustained (did not meet the sustainment benchmark), will begin engaging in high-touch activities. The higher intensity support will consist of facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship. Facilitation will be provided by Function QUERI team members. | Other: Implementation Strategy: Enhanced Support<br>* The goal is to test implementation intensification approaches for STRIDE hospitals that have not met implementation program benchmarks, specifically Foundational Support vs. Enhanced Support. We posit that monitoring hospitals' progress and adding, for hospitals with low adoption, higher intensity strategies (defined as Enhanced Support) that directly influence teams' capacity and skills to effectively self-organize and problem-solve will lead to higher implementation adoption, penetration, fidelity, and value.<br>* Other names: Enhanced REP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration | Penetration is defined as the proportion of eligible hospitalizations with one or more STRIDE walks at 10 months. It is not possible to assess all eligibility criteria in the EHR (e.g. able to walk at baseline); thus, with this more inclusive denominator, 100% penetration is not an appropriate goal. Based on preliminary data, we anticipate penetration to range from 0% (no program activity at 10-month outcome assessment) to 40% (estimated maximum achievable based on data from current STRIDE sites). | 10 months (cumulative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity | Fidelity will be the percentage of eligible hospital days with full dose of the program, defined as two or more documented walks or one walk for more than five minutes. | 10 months (cumulative) | 
| Adoption | Program adoption is a binary outcome defined as equal to or more than 5 patients with a STRIDE walk or not. | 10 months (cumulative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Veterans, Inpatients, Quality of Life, Implementation Science, Functional Independence, Early Ambulation