Optimizing Function and Independence Through STRIDE (STRIDE)

Optimizing Function and Independence Through STRIDE (QUE 16-170)

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.

Study Overview

• Status: Completed
• Conditions: Early Ambulation
• Intervention / Treatment: Behavioral: STRIDE

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.

• Study Type: Interventional
• Enrollment (Actual): 13857
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Implementation of STRIDE program	Behavioral: STRIDE; Implementation of STRIDE inpatient hospital mobility program
No Intervention: Usual Care; Pre-implementation before STRIDE program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay (Days)	Hospital length of stay will be assessed via administrative data pulls (not patient report)	Assessed at hospital discharge, an average of 7 days
Proportion of Patients Discharged to Skilled Nursing Facility	Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).	Assessed at hospital discharge, an average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Physical Function - Disability	Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.	30 days following hospital discharge, hospital stay an average of 6 days
Patient Physical Function - Limitations	Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.	30 days following hospital discharge, hospital stay an average of 6 days
Patient Physical Function	Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.	30 days following hospital discharge, hospital stay an average of 6 days
Proportion Highly Satisfied With Care	Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item "Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?" Responses were categorized into two categories: highly satisfied (responses of "Definitely Yes") and less satisfied (responses of "Probably Yes", "Probably No", and "Definitely No").	30 days following hospital discharge, hospital stay an average of 6 days
Health Utility	Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.	30 days following hospital discharge, hospital stay an average of 6 days
Health-related Quality of Life	Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.	30 days following hospital discharge, hospital stay an average of 6 days
Mobility in the Environment	Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.	30 days following hospital discharge, hospital stay an average of 6 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.	30 days following hospital discharge, hospital stay an average of 6 days
Proportion of Participants Self-reporting at Least One Fall	Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.	30 days following hospital discharge, hospital stay an average of 6 days
PROMIS-29 Pain Subscale	Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.	30 days following hospital discharge, hospital stay an average of 6 days
Depression	Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms	30 days following hospital discharge, hospital stay an average of 6 days

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Virginia Wang, PhD, Durham VA Medical Center, Durham, NC; Principal Investigator: Courtney H Van Houtven, PhD, Durham VA Medical Center, Durham, NC; Principal Investigator: Susan N. Hastings, MD MHSc, Durham VA Medical Center, Durham, NC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Function QUERI program

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): March 29, 2020
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Veterans; Walking; Inpatients; Early Ambulation
• Other Study ID Numbers: QUX 16-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study 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.

• IPD Sharing Time Frame: Available upon request.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No