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

NCT06066541 | Completed Results DMC

• 2 other identifiers: 2023p002222P30AG064199
• Study Type: interventional
• Target: 65,177
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 4 months

Secondary Outcomes (1)

• Proportion of Participants With End-of-year PDC≥80%

  approximately 4 months

Study Arms (7)

Scorecard

ACTIVE COMPARATOR

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

Scorecard + Social norms

EXPERIMENTAL

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; Behavioral: Social norms

Scorecard + Messenger effects

EXPERIMENTAL

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; Behavioral: Messenger effects

Processing fluency

EXPERIMENTAL

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

Processing fluency + Social norms

EXPERIMENTAL

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; Behavioral: Processing fluency

Processing fluency + Messenger effects

EXPERIMENTAL

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; Behavioral: Processing fluency

Usual care

NO INTERVENTION

Participants randomized to this arm will not receive any mailed message.

Interventions

Scorecard BEHAVIORAL

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

Scorecard; Scorecard + Messenger effects; Scorecard + Social norms

Social norms BEHAVIORAL

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

Processing fluency + Social norms; Scorecard + Social norms

Messenger effects BEHAVIORAL

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

Processing fluency + Messenger effects; Scorecard + Messenger effects

Processing fluency BEHAVIORAL

Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Processing fluency; Processing fluency + Messenger effects; Processing fluency + Social norms

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Humana, Inc.

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Keller P, Robertson T, Kao LS, Li Y, Merrell B, Chung L, Boudreau E, James A, Esterly L, Hanken K, Choudhry NK. Incorporating Behavioral Science in Medication Adherence Communication: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510162. doi: 10.1001/jamanetworkopen.2025.10162.

  PMID: 40366654 DERIVED

MeSH Terms

Conditions

Medication Adherence; Hypertension

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Niteesh Choudhry, MD, PhD
• Organization: Brigham and Women's Hospital

nkchoudhry@bwh.harvard.edu

617-278-0930

Study Officials

• Ted Robertson, MPA

  Ideas42

  PRINCIPAL INVESTIGATOR

• Punam Keller, PhD, MBA

  Tuck School of Business at Dartmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: August 18, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

US (1)