AWV Practice Redesign Toolkit (Tailored Intervention)

Preventive Health Services Clinical Trial

Official title:

Medicare Annual Wellness Visit Practice Redesign Toolkit: A Tailored Intervention to Improve Preventive Health Services Use (Phase 2)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05563415
• Other study ID #: R33AG068946
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 13321
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Preventive Health Services

Intervention

Behavioral:
• Medicare AWV Practice Redesign Toolkit
Electronic health record-based tools coupled with practice redesign strategies and approaches

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Academy of Family Physicians National Research Network, DARTNet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of recommended preventive health services	% of patients up to date on each of the preventive health services listed below.; Vaccinations; Influenza vaccine; Herpes zoster vaccine; Pneumococcal vaccine; Tetanus vaccine; Cancer screening; Colorectal cancer screening; Mammogram; Pap smear; Other screening; Osteoporosis screening; Hepatitis C screening; Alcohol misuse screening; Depression screening; Tobacco use screening; Advance care planning	through study completion, 12 months after intervention implementation in all practices
Secondary	Completion of recommended preventive health services - composite score	% of total recommended preventive health services that are up to date (of a maximum of 12 recommended services per patient); measured on the patient-level	through study completion, 12 months after intervention implementation in all practices
Secondary	Overuse of preventive health services	% of patients using non-recommended preventive health services (e.g., prostate specific antigen screening)	through study completion, 12 months after intervention implementation in all practices