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

January 10, 2025 updated by: Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

65177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Humana, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Scorecard
Participants randomized to this arm will receive a scorecard from Humana reporting patients' medication adherence using a "refill score." Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
Experimental: Scorecard + Social norms
Participants randomized to this arm will receive the Arm 1 scorecard plus dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).
Experimental: Scorecard + Messenger effects
Participants randomized to this arm will receive the Arm 1 scorecard, coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.
Experimental: Processing fluency
Participants randomized to this arm will receive a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."
Experimental: Processing fluency + Social norms
Participants randomized to this arm will receive the Arm 4 processing fluency scorecard plus dynamic social norms messaging. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."
Experimental: Processing fluency + Messenger effects
Participants randomized to this arm will receive the Arm 4 processing fluency scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."
No Intervention: Usual care
Participants randomized to this arm will not receive any mailed message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average End-of-year Adherence Level
Time Frame: approximately 4 months
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 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With End-of-year PDC≥80%
Time Frame: approximately 4 months
As measured by the Proportion of Days Covered metric [PDC]
approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ted Robertson, MPA, Ideas42
  • Principal Investigator: Punam Keller, PhD, MBA, Tuck School of Business at Dartmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023p002222
  • P30AG064199 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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