NCT04868656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

April 27, 2021

Results QC Date

December 23, 2024

Last Update Submit

April 14, 2025

Conditions

Keywords

WalkingVeteransInpatientsQuality of LifeImplementation ScienceFunctional IndependenceEarly Ambulation

Outcome Measures

Primary Outcomes (1)

  • 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).

    10 months (cumulative)

Secondary Outcomes (2)

  • Fidelity

    10 months (cumulative)

  • Adoption

    10 months (cumulative)

Study Arms (2)

Foundational Support

ACTIVE COMPARATOR

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

Enhanced Support

EXPERIMENTAL

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

Interventions

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.

Also known as: Foundational REP
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 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.

Also known as: Enhanced REP
Enhanced Support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The eight STRIDE hospitals that have previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03300336) will be excluded from enrollment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (2)

  • Kappler CB, Coffman CJ, Stechuchak KM, Choate A, Meyer C, Zullig LL, Hughes JM, Drake C, Sperber NR, Kaufman BG, Van Houtven CH, Allen KD, Hastings SN. Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial. Implement Sci Commun. 2024 Jan 12;5(1):8. doi: 10.1186/s43058-024-00544-5.

  • Hughes JM, Zullig LL, Choate AL, Decosimo KP, Wang V, Van Houtven CH, Allen KD, Nicole Hastings S. Intensification of Implementation Strategies: Developing a Model of Foundational and Enhanced Implementation Approaches to Support National Adoption and Scale-up. Gerontologist. 2023 Mar 21;63(3):604-613. doi: 10.1093/geront/gnac130.

Results Point of Contact

Title
Dr. Susan N. Hastings, MD, M.H.Sc
Organization
Durham VA Medical Center

Study Officials

  • Susan N. Hastings, MD MHSc

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR
  • Courtney H Van Houtven, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR
  • Kelli Dominick Allen, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 3, 2021

Study Start

June 1, 2021

Primary Completion

January 26, 2024

Study Completion

January 26, 2024

Last Updated

May 1, 2025

Results First Posted

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon request.
Access Criteria
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.

Locations