Study protocol: type II hybrid effectiveness-implementation study of routine functional status screening in VA primary care.
Francesca M Nicosia, Kara Zamora, LauraEllen Ashcraft...
https://pubmed.ncbi.nlm.nih.gov/39891277Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID06404970
A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care
Led by VA Office of Research and Development · Updated on 2025-07-18
10000
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a patient-centered, low-burden intervention designed to improve the measurement of functional status in older Veterans receiving care in VA primary care settings. Functional status refers to the ability to perform daily activities such as bathing, dressing, and preparing meals, which is vital for quality of life and independence. The study aims to increase identification and management of functional impairment and frailty to inform better care and strategic planning for long-term services and supports. The intervention includes routine, standardized functional status measurement combined with nursing screening, follow-up assessments by primary care providers, electronic tools for screening and documentation, educational sessions for care teams, and tailored reports. The study begins with a 3-month run-in period using standard implementation strategies like champions and system-level audit and feedback. Sites with lower screening uptake will be randomly assigned to receive either continued standard strategies or enhanced strategies including technical assistance and clinician-level audit and feedback, followed by crossover and further standard implementation periods. Participants will be Veterans aged over 60 who receive care in VA primary care after the study starts. Researchers will monitor changes in screening reach, clinical effectiveness, adoption, fidelity, patient experience, and sustainability over 24 months. Data from electronic health records and functional status assessments will be collected regularly. The study measures outcomes at multiple time points up to two years to evaluate the impact of the intervention on managing functional impairment and frailty among older Veterans.
CONDITIONS
Brief Title
A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Veteran
- Older than 60 years
- Receiving care in Veterans Health Administration primary care after study implementation begins
You will not qualify if you...
- Not a Veteran
- Younger than 60 years
- Not receiving care in Veterans Health Administration primary care after study begins
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Surveillance
Duration - 24 months
Participants are observed as the study implements a functional status screening initiative alongside standard or enhanced implementation strategies to improve identification and management of functional impairment.
Regular assessments during routine primary care visits
Trial Site Locations
Total: 1 location
1
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Actively Recruiting
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Research Team
R
Rebecca T Brown, MD MPH
J
Jason Prigge, BS MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SCREENING
Number of Arms
2
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