Clinical trial NCT06066541: 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
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Humana Inc.
name: National Institute on Aging (NIA)
First posted: 2023-10-04
Enrollment: 65177
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Average End-of-year Adherence Level
timeFrame: approximately 4 months
Secondary outcomes:
measure: Proportion of Participants With End-of-year PDC≥80%
timeFrame: approximately 4 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Humana, Inc.
state: Kentucky
Study officials:
affiliation: Ideas42
name: Ted Robertson, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuck School of Business at Dartmouth
name: Punam Keller, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: