Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence

Hypertension Clinical Trial

Official title:

Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06066541
• Other study ID #: 2023p002222
• Secondary ID: P30AG064199
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medicare Advantage beneficiaries ages 65-79 and insured by Humana with at least two unique fills of hypertension medication within the 2023 calendar year and adherence level between 60 and 85% will be identified using Humana Medicare Advantage claims data. Individuals meeting these inclusion criteria will be included and, with an institutional review board approved waiver of informed consent, will be randomized to one of 6 mailed messages or control (no message). The messages will be sent by Humana and use different behavioral techniques (social norms, messenger effects, and/or processing fluency) providing their medication refill score. Humana will send a second message within 60 days of the first message noting any changes in the refill score. The primary outcome will be the average end-of-year adherence in each arm. A secondary outcome will be the proportion of study participants with end-of-year adherence greater than or equal to 80%. The study team's hypothesis is that messages using dynamic social norms, messenger effects, and processing fluency in combination will more effectively increase average end-of-year adherence level compared to usual care. Humana will conduct all study participant outreach and data analyses, which will be performed using routinely collected insurance claims data. Regulatory oversight is conducted using Humana's centralized institutional review board (IRB) of record. The work completed by Humana study staff is funded by Humana, Inc. Dr. Choudhry and his colleagues (including subaward recipients ideas42 and Tuck School of Business at Dartmouth) will provide technical and subject matter expertise related to study research design and implementation, protocol design, statistical analysis, publication (abstract, poster, manuscript) preparation and/or review, and assistance throughout the peer review process including revisions and additional analyses if necessary for this project. The work completed by study staff at Brigham and Women's Hospital, ideas42, and Tuck School of Business at Dartmouth is funded by NIA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59997
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

Inclusion Criteria:

• Medicare Advantage beneficiary insured by Humana
• Between the ages of 65 and 79
• Having at least two unique fills of any class of hypertension medication within the calendar year (2023).
• Adherence level (as measured by the proportion of days covered [PDC] metric) between 60% and 85%

Exclusion Criteria:

• Beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Scorecard
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
• Social norms
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).
• Messenger effects
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.
• Processing fluency
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Locations

Country	Name	City	State
United States	Humana, Inc.	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Humana Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average end-of-year adherence level	The primary outcome will be the average end-of-year adherence level in each arm (as measured by the Proportion of Days Covered metric [PDC]) stratified by refill cycle and adjusting for age, sex, and race.	approximately 6 months
Secondary	Proportion of participants with end-of-year PDC=80%	As measured by the Proportion of Days Covered metric [PDC]	approximately 6 months