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

Primary Purpose

Medication Adherence, Hypertension

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scorecard
Social norms
Messenger effects
Processing fluency
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Adherence

Eligibility Criteria

65 Years - 79 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Humana, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Scorecard

Scorecard + Social norms

Scorecard + Messenger effects

Processing fluency

Processing fluency + Social norms

Processing fluency + Messenger effects

Usual care

Arm Description

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 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 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 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 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 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 randomized to this arm will not receive any mailed message.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of participants with end-of-year PDC≥80%
As measured by the Proportion of Days Covered metric [PDC]

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Humana Inc., National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06066541
Brief Title
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
Official Title
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Humana Inc., National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59997 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scorecard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Scorecard + Social norms
Arm Type
Experimental
Arm Description
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.
Arm Title
Scorecard + Messenger effects
Arm Type
Experimental
Arm Description
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.
Arm Title
Processing fluency
Arm Type
Experimental
Arm Description
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.
Arm Title
Processing fluency + Social norms
Arm Type
Experimental
Arm Description
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.
Arm Title
Processing fluency + Messenger effects
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will not receive any mailed message.
Intervention Type
Behavioral
Intervention Name(s)
Scorecard
Intervention Description
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
Intervention Type
Behavioral
Intervention Name(s)
Social norms
Intervention Description
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).
Intervention Type
Behavioral
Intervention Name(s)
Messenger effects
Intervention Description
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.
Intervention Type
Behavioral
Intervention Name(s)
Processing fluency
Intervention Description
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."
Primary Outcome Measure Information:
Title
Average end-of-year adherence level
Description
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.
Time Frame
approximately 6 months
Secondary Outcome Measure Information:
Title
Proportion of participants with end-of-year PDC≥80%
Description
As measured by the Proportion of Days Covered metric [PDC]
Time Frame
approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Robertson, MPA
Organizational Affiliation
Ideas42
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Punam Keller, PhD, MBA
Organizational Affiliation
Tuck School of Business at Dartmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humana, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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

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