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/39891277/Actively Recruiting
Led by VA Office of Research and Development · Updated on 2026-06-18
10000
Participants Needed
1
Research Sites
4 weeks
Total Duration
Maintaining the ability to perform daily activities is crucial for the quality of life, health, and independence of older adults. This research focuses on improving how functional impairments and frailty are identified and managed among older Veterans in primary care settings within the Veterans Health Administration VHA. The study aims to increase the use of standardized, low-burden tools to measure functional status, which has been challenging to implement widely due to the complexity of current methods. The initiative aligns with national VA priorities to support aging Veterans and improve healthcare planning. The study evaluates a patient-centered intervention called the PACT Function Initiative, which includes routine, standardized functional status measurement, nursing screening with primary care follow-up, electronic tools for documentation, educational sessions for staff, and tailored reports on functional status. Initially, all participating sites will use a standard bundle of implementation strategies such as champions and system-level audit and feedback. Sites with lower uptake after three months will be randomized to receive either continued standard implementation or an enhanced bundle that adds technical assistance and clinician-level audit and feedback. The study includes phases of pre-implementation, implementation, crossover allocation, and sustainment. Participants, who are older Veterans seen in VA primary care, will be part of assessments over 24 months. Researchers will measure changes in reach, clinical effectiveness, adoption, fidelity, patient experience, sustainability, and functional status using electronic health records and screening data. The study collects data at multiple time points to evaluate the impact of implementing the intervention. This ongoing monitoring will help inform strategies for better managing functional impairment and frailty in this population.
CONDITIONS
A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
R
Rebecca T Brown, MD MPH
J
Jason Prigge, BS MS
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VA Office of Research and Development
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Enhanced bundle with screening | Standard bundle with screening |
|---|---|---|
| What it is | Routine functional status screening combined with enhanced implementation strategies (technical assistance plus clinician-level audit and feedback) | Routine functional status screening combined with standard implementation strategies (champions, system-level audit and feedback) |
| Role in the study | One of two crossover implementation strategy conditions | One of two crossover implementation strategy conditions |
| Primary purpose | To identify and improve management of functional impairment and frailty in older Veterans | To identify and improve management of functional impairment and frailty in older Veterans |
| How it is delivered | Screening initiative augmented by technical assistance and clinician-level audit and feedback | Standard screening initiative with champions plus system-level audit and feedback |
| Evidence status | Effectiveness being evaluated in hybrid effectiveness‑implementation study | Effectiveness being evaluated in hybrid effectiveness‑implementation study |
| Important risks | Not applicable for implementation strategy | Not applicable for implementation strategy |
| Important limitations | Effectiveness and sustainability remain to be seen in real‑world VA primary care | Effectiveness and sustainability remain to be seen in real‑world VA primary care |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive the functional status screening intervention through primary care with either a standard or enhanced bundle of implementation strategies at their VA medical center. Sites are initially supported with standard strategies; sites with lower uptake are randomized to continue standard or receive enhanced support including technical assistance and clinician feedback. After crossover allocation, all sites return to standard implementation.
Duration - Up to 12 months
Participants continue to receive functional status screening as part of routine care while researchers monitor long-term adoption and effectiveness of the intervention.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SCREENING
Number of Arms
2
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Francesca M Nicosia, Kara Zamora, LauraEllen Ashcraft...
https://pubmed.ncbi.nlm.nih.gov/39891277/VA Office of Research and Development
Lead Sponsor