Clinical trial NCT04868656: Implementing a Hospital-Based Walking Program (STRIDE): Function QUERI 2.0
Official title: Implementing a Hospital-Based Walking Program (STRIDE): Function QUERI 2.0 (QUE 20-023)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Ambulation
Keywords: Walking
Veterans
Inpatients
Quality of Life
Implementation Science
Functional Independence
Early Ambulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-05-03
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Penetration
timeFrame: 10 months (cumulative)
Secondary outcomes:
measure: Fidelity
timeFrame: 10 months (cumulative)
measure: Adoption
timeFrame: 10 months (cumulative)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Courtney H Van Houtven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Kelli Dominick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: