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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868656
Acronym
STRIDE
Enrollment
35
Registered
2021-05-03
Start date
2021-06-01
Completion date
2024-01-26
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Ambulation

Keywords

Walking, Veterans, Inpatients, Quality of Life, Implementation Science, Functional Independence, Early Ambulation

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.

Interventions

OTHERImplementation 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.

OTHERImplementation 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Penetration10 months (cumulative)Penetration is defined as the percent of eligible hospitalizations with one or more STRIDE walks at 10 months. It is not possible to assess all eligibility criteria in the Electronic Health Record (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).

Secondary

MeasureTime frameDescription
Fidelity10 months (cumulative)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.
Adoption10 months (cumulative)Program adoption is a binary outcome defined for each hospital as equal to or more than 5 patients with a STRIDE walk or not.

Countries

United States

Participant flow

Recruitment details

VA hospitals were enrolled in five successive cohorts from June 1, 2021 to October 3, 2022.

Participants by arm

ArmCount
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. 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.
0
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. 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.
19
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. 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.
0
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. 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.
16
Total35

Baseline characteristics

CharacteristicFoundational SupportTotalEnhanced Support
Adjusted Length of Stay
Greater than or equal to 4.7 days
12 Hospital22 Hospital10 Hospital
Adjusted Length of Stay
Less than 4.7 days
7 Hospital13 Hospital6 Hospital
Facility Complexity Scores
1a
8 Hospital14 Hospital6 Hospital
Facility Complexity Scores
1b, 1c, 2 , 3
11 Hospital21 Hospital10 Hospital
Prior Mobility Program Experience
No
13 Hospital24 Hospital11 Hospital
Prior Mobility Program Experience
Yes
6 Hospital11 Hospital5 Hospital
Race (NIH/OMB)
American Indian or Alaska Native
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
Asian
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
Black or African American
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
More than one race
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
Unknown or Not Reported
NA HospitalNA HospitalNA Hospital
Race (NIH/OMB)
White
NA HospitalNA HospitalNA Hospital
Region of Enrollment
United States : Midwest
5 Hospital10 Hospital5 Hospital
Region of Enrollment
United States : Northeast
3 Hospital6 Hospital3 Hospital
Region of Enrollment
United States : South
5 Hospital8 Hospital3 Hospital
Region of Enrollment
United States : West
6 Hospital11 Hospital5 Hospital
Sex: Female, Male
Female
0 Hospital
Sex: Female, Male
Male
0 Hospital

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Penetration

Penetration is defined as the percent of eligible hospitalizations with one or more STRIDE walks at 10 months. It is not possible to assess all eligibility criteria in the Electronic Health Record (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).

Time frame: 10 months (cumulative)

Population: Data collected at the site level

ArmMeasureValue (MEAN)Dispersion
Foundational SupportPenetration4.3 percentage of eligible hospitalizationsStandard Deviation 4.7
Enhanced SupportPenetration2.2 percentage of eligible hospitalizationsStandard Deviation 3
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).p-value: 0.1595% CI: [-5, 0.8]Regression, Linear
Secondary

Adoption

Program adoption is a binary outcome defined for each hospital as equal to or more than 5 patients with a STRIDE walk or not.

Time frame: 10 months (cumulative)

Population: Data collected at the site level

ArmMeasureValue (NUMBER)
Foundational SupportAdoption13 Hospitals with Program Adoption
Enhanced SupportAdoption9 Hospitals with Program Adoption
Comparison: Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.p-value: 0.2395% CI: [0.1, 2.5]Regression, Logistic
Secondary

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.

Time frame: 10 months (cumulative)

Population: Data collected at the site level

ArmMeasureValue (MEAN)Dispersion
Foundational SupportFidelity35 percentage of eligible hospital daysStandard Deviation 10
Enhanced SupportFidelity40 percentage of eligible hospital daysStandard Deviation 14
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).p-value: 0.3495% CI: [-6, 16.6]Regression, Linear

Source: ClinicalTrials.gov · Data processed: Aug 10, 2026