AWV Practice Redesign Toolkit (Tailored Intervention)

NCT ID: NCT05563415

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-09-30

Brief Summary

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.

Detailed Description

This is a multi-site, stepped wedge cluster randomized controlled trial to evaluate the effect of the AWV Practice Redesign Toolkit on AWV and preventive health services use. The study will take place in 16 primary care practices around the United States. 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. Recruitment occurs at the level of the practice. The investigators hypothesize that the intervention will increase uptake of AWVs and use of preventive health services.

The stepped wedge cluster design is a pragmatic study design that includes an initial control period in which no clusters receive the intervention. Randomized clusters cross to the intervention condition at regular intervals, and there is a period at the end of the study where all clusters have been exposed to the intervention. Data are collected throughout the study so that each cluster contributes to both the control and intervention periods. The intervention will be implemented sequentially over 16 months, with 4 clusters of 4 practices each switching from control to intervention every 4 months between months 4-20. By month 20 of the study all practices will have completed intervention implementation. Each cluster will have a 4 month transition period during intervention implementation.

In addition to the procedures described above, the investigators will collect qualitative semi-structured interview data on a subset of patients (up to n=10), and clinicians/staff (up to n=10) from each practice to assess fidelity to the intervention.

Outcomes will be assessed through EHR data extractions, which will be led by the DARTNet Institute (co-investigator Wilson Pace). Data will be sent from the DARTNet Institute to the American Academy of Family Physicians National Research Network (AAFP NRN) for cleaning, de-identification and creation of flags. The AAFP NRN has established contracts and agreements with the DARTNet Institute that enables them to access DARTNet's data. The AAFP NRN will deliver a limited dataset to investigators at the University of California, Los Angeles for analyses.

Conditions

Preventive Health Services

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Medicare AWV Toolkit

This is a stepped-wedged study. All practices will receive the intervention.

Group Type: OTHER

Medicare AWV Practice Redesign Toolkit

Intervention Type: BEHAVIORAL

Electronic health record-based tools coupled with practice redesign strategies and approaches

Interventions

Medicare AWV Practice Redesign Toolkit

Electronic health record-based tools coupled with practice redesign strategies and approaches

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• have Medicare coverage
• aged 50 or older
• has at least one visit to the practice in the past 12 months
• not deceased

Practice eligibility criteria:

• care for patients with Medicare insurance

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DARTNet

UNKNOWN

Sponsor Role: collaborator

American Academy of Family Physicians National Research Network

NETWORK

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Derjung Tarn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derjung M Tarn, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

R33AG068946

Identifier Type: NIH

Identifier Source: org_study_id

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