NCT05563415

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,321

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2023Sep 2026

First Submitted

Initial submission to the registry

September 14, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

November 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

September 14, 2022

Last Update Submit

October 30, 2025

Conditions

Preventive Health Services

Keywords

older patientsMedicare Annual Wellness Visitspreventive health care

Outcome Measures

Primary Outcomes (1)

  • AWV utilization

    % of eligible patients completing an AWV (CPT codes G0438 or G0439) or Initial Preventive Physical Examination (IPPE) (CPT code G0422) in the past 12 months

    through study completion, 12 months after intervention implementation in all practices

Secondary Outcomes (3)

  • Completion of recommended preventive health services

    through study completion, 12 months after intervention implementation in all practices

  • Completion of recommended preventive health services - composite score

    through study completion, 12 months after intervention implementation in all practices

  • Overuse of preventive health services

    through study completion, 12 months after intervention implementation in all practices

Study Arms (1)

Medicare AWV Toolkit

OTHER

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

Behavioral: Medicare AWV Practice Redesign Toolkit

Interventions

Medicare AWV Practice Redesign ToolkitBEHAVIORAL

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

Medicare AWV Toolkit

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Study Officials

  • Derjung M Tarn, MD,PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped Wedge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2022

First Posted

October 3, 2022

Study Start

May 15, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

November 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The research team will engage the University of California Curation Center (UC3) to serve as the data repository for all components of the project. The research team will work with UC3 to curate and deliver to the curation center definition of data elements extracted from EHR and source data in a standardized, de-identified format. We also will include statistical codes for analyses in the form of R, SAS or STATA files. The DRYAD system within the UC3 provides a platform to publish the metadata concerning the project that researchers globally can access. This system will serve as the data repository in which we will house the data management plan for the source data as well as metadata that describes the source data and code books of the underlying data elements, with record counts such that outside researchers can have a full understanding of what is housed in the system.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Within 6 months of publication of the main effects paper. Data will be permanently archived and available.
Access Criteria
Where possible data will be shared in an open file format, so proprietary software is not required to view or use the files. All datasets will be indexed by the Thomson-Reuters Data Citation Index, Scopus, and Google Dataset Search. Each dataset is given a unique Digital Object Identifier or DOI. Entering the DOI URL in any browser will take the user to the dataset's landing page. Dryad also provides a faceted search and browse capability for direct discovery. Dryad has implemented the Make Data Count project recommendations. This means that that views and downloads on each dataset landing page are standardized against the COUNTER Code of Practice for Research Data. Within this framework, Dryad also exposes all related citations to a dataset on the landing page. These are updated each time a new citation from an article or other source has been published.

Locations

US(1)