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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06066541
Collaborator
Humana Inc. (Industry), National Institute on Aging (NIA) (NIH)
59,997
1
7
4.4
13527.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Scorecard
  • Behavioral: Social norms
  • Behavioral: Messenger effects
  • Behavioral: Processing fluency
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
59997 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
Actual Study Start Date :
Aug 18, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Behavioral: Scorecard
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.

Behavioral: Scorecard
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Behavioral: Social norms
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.

Behavioral: Scorecard
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Behavioral: Messenger effects
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.

Behavioral: Processing fluency
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.

Behavioral: Social norms
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).

Behavioral: Processing fluency
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.

Behavioral: Messenger effects
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.

Behavioral: Processing fluency
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.

Outcome Measures

Primary Outcome Measures

  1. Average end-of-year adherence level [approximately 6 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.

Secondary Outcome Measures

  1. Proportion of participants with end-of-year PDC≥80% [approximately 6 months]

    As measured by the Proportion of Days Covered metric [PDC]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humana, Inc. Louisville Kentucky United States 40202

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • Humana Inc.
  • National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Niteesh K. Choudhry, MD, PhD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT06066541
Other Study ID Numbers:
  • 2023p002222
  • P30AG064199
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023