- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513805
Implementation of Routine Walking Speed Measurements in Older Veterans
Walking Speed as a Vital Sign: Enhancing Function in Older Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Walking speed is a vital sign that can predict mortality and adverse health outcomes in older adults. However, it is not routinely assessed in outpatient primary care clinics, potentially leading to missed opportunities for timely intervention and rehabilitative care. Current literature identifies walking speed as a sensitive measure of overall health and functional status, with a walking speed of <0.6 m/s indicating increased risk of adverse events and reduced independence. Consequently, knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Importantly, walking speed is also a modifiable risk factor and is sensitive to change in multiple populations with varying medical conditions, making it an ideal measure for longitudinal monitoring of physical function. The investigators' preliminary work implementing walking speed measurement into outpatient geriatric clinical care, along with recent literature, demonstrates that routine walking speed assessments are feasible, quick, and safe.
Significance: Current VHA standard of care within primary care clinics relies on subjective information to evaluate a Veteran's physical function, which can be unreliable and inaccurate. Implementation of walking speed will introduce an objective measure that can accurately assess how a Veteran's physical function changes over time, thus helping providers identify whether referrals to rehabilitation services are needed.
Innovation and Impact: This proposal is innovative as it will be one of the first studies to assess the implementation and effect of walking speed across multiple primary care clinics. Additionally, examination of contextual factors influencing the implementation and effect of walking speed is innovative and will lead to adaptations that facilitate future widespread implementation.
Methodology: Pragmatic hybrid type 2 effectiveness-implementation study using a stepped-wedge cluster randomized trial design to evaluate and improve walking speed implementation and assess its effectiveness across VHA PACT clinics.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer E Stevens-Lapsley, PhD
- Phone Number: (303) 949-9304
- Email: Jennifer.Stevens-Lapsley@va.gov
Study Contact Backup
- Name: Joyce A Middleton
- Phone Number: (303) 908-8935
- Email: joyce.middleton@va.gov
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Principal Investigator:
- Jennifer E. Stevens-Lapsley, PhD
-
Contact:
- Jennifer E Stevens-Lapsley, PhD
- Phone Number: 303-949-9304
- Email: Jennifer.Stevens-Lapsley@va.gov
-
Contact:
- Joyce A Middleton
- Phone Number: (303) 908-8935
- Email: joyce.middleton@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Site Inclusion Criteria:
- VHA primary care clinics
VHA Personnel Inclusion Criteria:
- Providers working in a VHA primary care clinic where FASTER is implemented
- Nursing staff working in a VHA primary care clinic where FASTER is implemented
Veteran Inclusion Criteria:
- Veterans 60 years and older receiving care in a VHA primary care clinic where FASTER is implemented
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care
Usual care will continue in clinical practice with this phase occurring before FASTER implementation.
|
During the Usual Care phase, participating clinics will continue with usual care with the addition that walking speed will be measured and recorded.
Veterans and providers will be blinded to walking speed measurement so as to not influence care.
|
|
Experimental: FASTER
The FASTER intervention includes measurement, recording, and use of walking speed measurement to help guide care in older Veterans.
|
During the FASTER phase, walking speed will be measured during clinic visits, recorded in the medical record, and used by providers to guide care.
An Action Toolkit will be provided with resources for providers to support informed care decisions based on Veterans' walking speeds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking Speed
Time Frame: Change in walking speed before exposure and change in walking speed after exposure to FASTER intervention (up to 12 months).
|
Time to complete 4-meter walk at usual speed converted to meters per second.
Higher speed indicates better function.
|
Change in walking speed before exposure and change in walking speed after exposure to FASTER intervention (up to 12 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events (Injurious Falls)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Falls that result in a medical visit
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
Adverse Events (Emergency Department Visits and Hospitalizations)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Emergency department visits and hospitalizations
|
Start of usual care to end of implementation (anticipated 24 months).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RE-AIM Component: Reach
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Proportion of visits with a walking speed measured out of all in-person primary care visits (Veterans ≥65 years of age)
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
RE-AIM Component: Adoption (Providers)
Time Frame: Start of implementation.
|
Proportion of providers that state they will use walking speed information
|
Start of implementation.
|
|
RE-AIM Component: Adoption (Assessors)
Time Frame: Start of usual care.
|
Proportion of assessors that state they will measure walking speed
|
Start of usual care.
|
|
RE-AIM Component: Adoption (Clinics)
Time Frame: Start of usual care.
|
Proportion of clinics that state they will implement walking speed
|
Start of usual care.
|
|
RE-AIM Component: Implementation (Walking Speed Measurement)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Proportion of completed walking speed measurement elements out of all elements
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
RE-AIM Component: Implementation (Walking Speed Initiative Elements)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Proportion of completed walking speed initiative elements out of all intervention elements
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
RE-AIM Component: Implementation (Walking Speed Measurement Total Time)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Time to complete walking speed measurement and documentation
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
RE-AIM Component: Implementation (Walking Speed Measurement Relative Time)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Time to complete walking speed measurement relative to total rooming procedures
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
RE-AIM Component: Maintenance (Walking Speed Measurement)
Time Frame: Up to 6 months after Implementation phase.
|
Proportion of completed walking speed measurement elements out of all elements
|
Up to 6 months after Implementation phase.
|
|
RE-AIM Component: Maintenance (Walking Speed Initiative Elements)
Time Frame: Up to 6 months after Implementation phase.
|
Proportion of completed walking speed initiative elements out of all intervention elements
|
Up to 6 months after Implementation phase.
|
|
Referrals (Physical Therapy/Gerofit)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Change in VHA referrals to physical therapy/Gerofit
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
Referrals (Follow-Through)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Proportion of referrals that result in follow-through
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
Referrals (Recommendations)
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Count of recommendations for community exercise programs, home exercise, physical activity promotion
|
Start of usual care to end of implementation (anticipated 24 months).
|
|
Adaptations
Time Frame: Start of usual care to end of implementation (anticipated 24 months).
|
Number and type of adaptations at each VHA primary care clinical site
|
Start of usual care to end of implementation (anticipated 24 months).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer E. Stevens-Lapsley, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR6-009-24S
- I01HX003877 (Other Grant/Funding Number: VA Office of Research and Development)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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