Clinical trial NCT03300336: Optimizing Function and Independence Through STRIDE
Official title: Optimizing Function and Independence Through STRIDE (QUE 16-170)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Ambulation
Keywords: Walking
Inpatients
Veterans
Early Ambulation
Quality of Life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-10-03
Enrollment: 13857
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped Wedge Cluster Randomized Trial - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each cluster undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of clusters that will start the intervention at each period determined by random allocation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.

Detailed description: Background/Purpose. A key contributor to hospital-associated disability is immobility during hospitalization. While fewer than 5% of patients have physician orders for bed rest, hospitalized older adults spend only 3% of their time standing or walking. The hazards of immobility in the hospital have been recognized for more than two decades, but there are currently no VA-system wide approaches to address this important gap in clinical care.

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 GEC. STRIDE consists of a one-time gait and balance assessment conducted by a physical therapist, followed by daily supervised walks by a recreation therapy assistant for the duration of the hospital stay. Program evaluation has demonstrated high satisfaction among Veteran participants and reduced need for post-acute institutional care. As a result, the Durham VAMC funded STRIDE as a permanent program that currently serves over 650 Veterans annually, and the VHA Office of GEC funded a dissemination grant to launch the program at another medical center. The investigators' initial experience with STRIDE implementation suggests interprofessional relationships and team dynamics are key determinants to the success of a new hospital-based clinical program that requires collaborative processes involving multiple disciplines.

As part of the investigators' Optimizing Function and Independence QUERI, the investigators plan to implement the STRIDE clinical program at 8 VAMC sites in a stepped-wedge design with sites randomized to implementation strategy and start date.

Objectives. The investigators plan to conduct an evaluation to examine the impact of STRIDE on patient outcomes.

Key questions: Do STRIDE participants have fewer discharges to skilled nursing facilities and shorter lengths of stay? Do STRIDE participants have better physical function and higher health-related quality of life at 30 days post-discharge? What is the value of STRIDE from the Veteran's perspective? The investigators also plan to conduct a mixed method evaluation that examines implementation outcomes and provider team experience that will not be reported here.

Methodology. The investigators will compare patients discharged from sites before and after the STRIDE program is implemented to assess discharge to skilled nursing facilities and length of stay (approx. n=2000). A subset of patients participating in the STRIDE program and a comparison group will be surveyed 30 days post-hospital discharge to assess outcomes including health status, physical function, and quality of life. A subset of patients will be interviewed one week post-discharge to gain feedback about the STRIDE program and perceived benefits of a hospital inpatient mobility program.

In 2023, the following updates were made after results were initially uploaded to clinical trials as follows: primary outcome description and results were modified to reflect discharge to skilled nursing facility versus discharge to home and modifications were made to the sample and discharge to skilled nursing home and length of stay outcomes due to receipt of more complete data sources for use to determine eligibility and to assess the primary outcome.

Eligibility criteria: Inclusion Criteria:

Inclusion/Exclusion listed here apply to subset of patients providing consent for telephone interviews:

* Able and willing to provide informed consent (does not lack decision-making capacity)
* Discharged from a participating hospital within the preceding 30 days
* Age \>= 60
* Index admission for medical illness
* Community-dwelling (i.e. not in a nursing home or institutional care) prior to hospital visit
* Ability to ambulate safely and independently (does not need help walking across a small room)
* Valid telephone number in the medical record
* Admitted to a STRIDE ward and discharged from a STRIDE ward
* Index hospital stay was in a ward identified to participate in the STRIDE program

Exclusion Criteria:

* Patient deceased
* Index hospital stay was \< 2 business days
* Currently hospitalized
* Current high-risk suicide flag in medical record
* Diagnosis of cognitive impairment or dementia
* Difficulty with or unable to communicate on the telephone, or no telephone access
* Discharged to another hospital or acute care setting
* Transferred into index hospital from another hospital
* Bedrest order not lifted for at least 2 days on STRIDE ward

Primary outcomes:
measure: Proportion of Patients Discharged to Skilled Nursing Facility
timeFrame: Assessed at hospital discharge, an average of 7 days
measure: Hospital Length of Stay (Days)
timeFrame: Assessed at hospital discharge, an average of 7 days
Secondary outcomes:
measure: Patient Physical Function - Disability
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Patient Physical Function - Limitations
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Patient Physical Function
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Proportion Highly Satisfied With Care
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Health Utility
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Health-related Quality of Life
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Mobility in the Environment
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
Other outcomes:
measure: Sleep
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Proportion of Participants Self-reporting at Least One Fall
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: PROMIS-29 Pain Subscale
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
measure: Depression
timeFrame: 30 days following hospital discharge, hospital stay an average of 6 days
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: Virginia Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang V, D'Adolf J, Decosimo K, Robinson K, Choate A, Bruening R, Sperber N, Mahanna E, Van Houtven CH, Allen KD, Colon-Emeric C, Damush TM, Hastings SN. Adapting to CONNECT: modifying a nursing home-based team-building intervention to improve hospital care team interactions, functioning, and implementation readiness. BMC Health Serv Res. 2022 Jul 29;22(1):968. doi: 10.1186/s12913-022-08270-1.
citation: Hastings SN, Stechuchak KM, Choate A, Mahanna EP, Van Houtven C, Allen KD, Wang V, Sperber N, Zullig L, Bosworth HB, Coffman CJ. Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program. Trials. 2020 Oct 16;21(1):863. doi: 10.1186/s13063-020-04764-7.
citation: Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3.