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N/A N=59,997 Randomized Double-blind Health Services Research

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

Medication Adherence · Hypertension

Enrolled (actual)
59,997
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Average End-of-year Adherence Level — 0.81; 0.81; 0.81; 0.81 proportion of days covered

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Scorecard (Behavioral); Social norms (Behavioral); Messenger effects (Behavioral); Processing fluency (Behavioral)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Brigham and Women's Hospital
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Average End-of-year Adherence Level
0.81; 0.81; 0.81; 0.81; 0.81; 0.81
SECONDARY
Proportion of Participants With End-of-year PDC≥80%
6518; 6590; 6467; 6515; 6558; 6598

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06066541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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