- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066541
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Humana, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Ted Robertson, MPA, Ideas42
- Principal Investigator: Punam Keller, PhD, MBA, Tuck School of Business at Dartmouth
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on Scorecard
-
George Washington UniversityCompleted