Optimizing Function and Independence Through STRIDE

Early Ambulation Clinical Trial

— STRIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300336
• Other study ID #: QUX 16-015
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: October 30, 2021

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13857
• Est. completion date: October 30, 2021
• Est. primary completion date: March 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Ambulation

Intervention

Behavioral:
• STRIDE
Implementation of STRIDE inpatient hospital mobility program

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Function QUERI program