AWV Practice Redesign Toolkit (Tailored Intervention)

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Study completion pushed from Sep 30, 2026 to Jan 30, 2027
  2. Secondary endpoints: details revised at 1 of 3 entries
    • Collaborators: 2 to 3
    • Eligibility criteria expanded, about 5 words
  3. 2 versions Re-verified since Oct 30, 2025, no change to tracked fieldsv7-v8
  4. Study completion date: Sep 30, 2025 to Sep 30, 2026v6
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025
    v5
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  1. Enrollment target: 13300 to 13321
    • Primary and study completion dates: Aug 2025 to Aug 31, 2025
    v4
  2. Start date changed from estimate of May 1, 2023 to May 15, 2023v3
  3. Start date: Nov 1, 2022 to May 1, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to improve the use of preventive health services by implementing the AWV Practice Redesign Toolkit to stimulate AWV visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 16 small-to-mid-size primary care practices (at the practice level) with clinicians and staff. Eight practices will participate in the main clinical trial, and 8 in a replication study. The main clinical trial (with community-based practices) and replication study (with Federally Qualified Health Center practices) will be conducted simultaneously. Electronic health record (EHR) data extractions will be used to collect outcomes in a population cohort of patients. Semi-structured interviews will be conducted with clinicians/staff and patients to assess intervention implementation. The investigators hypothesize that the toolkit implementation will increase AWV visit use and consequently, use of preventive health services.
Trial Details
NCT Number NCT05563415
Lead Sponsor University of California, Los Angeles
Collaborators: DARTNet, American Academy of Family Physicians National Research Network, National Institute on Aging (NIA)
Conditions
(from sponsor)		 Preventive Health Services
Enrollment 13,321 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov