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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of a Hospital Walking Program for Older Adults

NCT00715962

Acute Disease

COMPLETED PHASE2

Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)

NCT01572311

Cognitive Impairment

COMPLETED NA

Aerobic Exercise and Cognitive Training in Older Adults

NCT02787655

Sedentary Lifestyle

COMPLETED NA

Life 2: Improving Fitness and Function in Elders

NCT00435188

Aging Mobility Limitations

COMPLETED NA

Development of a Power Training Program to Improve Mobility in Older Veterans

NCT07210645

Physical Deconditioning Mobility Decline

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 Veterans Health Administration (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Ambulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Foundational Support

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.

Group Type ACTIVE_COMPARATOR

Implementation Strategy: Foundational Support

Intervention Type OTHER

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.

Enhanced Support

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.

Group Type EXPERIMENTAL

Implementation Strategy: Enhanced Support

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation Strategy: Foundational Support

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.

Intervention Type OTHER

Implementation Strategy: Enhanced Support

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Foundational REP Enhanced REP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No