Clinical trial NCT05563415: AWV Practice Redesign Toolkit (Tailored Intervention)
Official title: Medicare Annual Wellness Visit Practice Redesign Toolkit: A Tailored Intervention to Improve Preventive Health Services Use (Phase 2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preventive Health Services
Keywords: older patients
Medicare Annual Wellness Visits
preventive health care
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: DARTNet
name: American Academy of Family Physicians National Research Network
First posted: 2022-10-03
Enrollment: 13321
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge
Primary purpose: PREVENTION

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.

Eligibility criteria: There are no inclusion or exclusion criteria based on sex/gender, race, and/or ethnicity.

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

Primary outcomes:
measure: AWV utilization
timeFrame: through study completion, 12 months after intervention implementation in all practices
Secondary outcomes:
measure: Completion of recommended preventive health services
timeFrame: through study completion, 12 months after intervention implementation in all practices
measure: Completion of recommended preventive health services - composite score
timeFrame: through study completion, 12 months after intervention implementation in all practices
measure: Overuse of preventive health services
timeFrame: through study completion, 12 months after intervention implementation in all practices
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Derjung M Tarn, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: