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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064199 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Humana Inc. | INDUSTRY |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scorecard | Behavioral | Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With End-of-year PDC≥80% | As measured by the Proportion of Days Covered metric [PDC] | approximately 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ted Robertson, MPA | Ideas42 | Principal Investigator |
| Punam Keller, PhD, MBA | Tuck School of Business at Dartmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humana, Inc. | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40366654 | Derived | 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. |
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We randomized 65,177 study participants before our study launched with recruitment starting in August 2023. We recruited in two waves (on August 18, 2023 and August 24, 2023) to ensure a sufficient sample size after adjusting for dropouts due to loss of eligibility or changes in membership.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Mailing (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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." |
| FG001 | Baseline Mailing + Dynamic 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). |
| FG002 | Baseline Mailing + 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. |
| FG003 | Baseline Mailing + 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. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| FG004 | Processing Fluency + Dynamic 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. Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| FG005 | 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. Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| FG006 | No Mailing (Usual Care) | Participants randomized to this arm will not receive any mailed message. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment Wave 1 (August 18, 2023) |
|
| ||||||||||||||||||
| Enrollment Wave 2 (August 24, 2023) |
|
We randomized 65,177 study participants before our study launched with recruitment starting in August 2023. We recruited in two waves (on August 18, 2023 and August 24, 2023) to ensure a sufficient sample size after adjusting for dropouts due to loss of eligibility or changes in membership. Our final sample consisted of 64,290 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Mailing (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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | proportion of days covered | approximately 4 months |
|
Adverse event data were collected from date of participant randomization through the end of participant follow-up for all participants. Adverse event data were collected from date of participant randomization through the end of participant follow-up. Wave 1 participants were assessed for approximately 19 weeks. Wave 2 participants were assessed for approximately 18 weeks.
Collection of adverse events was completed using a non-systematic assessment and was collected via self-report by Humana members.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Mailing (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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niteesh Choudhry, MD, PhD | Brigham and Women's Hospital | 617-278-0930 | nkchoudhry@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2023 | Sep 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| 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. |
|
| 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. |
|
| Usual care | No Intervention | Participants randomized to this arm will not receive any mailed message. |
| Social norms | Behavioral | Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). |
|
| 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 | Behavioral | Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Baseline Mailing + Dynamic 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). |
| BG002 | Baseline Mailing + 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. |
| BG003 | Baseline Mailing + 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. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| BG004 | Processing Fluency + Dynamic 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. Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| BG005 | 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. Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| BG006 | No Mailing (Usual Care) | Participants randomized to this arm will not receive any mailed message. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Refill cycle | Count of Participants | Participants |
|
| Low-Income Subsidy (LIS)/Dual Eligibility Status | Count of Participants | Participants |
|
| Hypertension proportion of days covered (PDC) as of selection | proportion of days covered (PDC) in prescription insurance claims following the Medicare Star Ratings approach | Mean | Standard Deviation | proportion of days covered (PDC) |
|
| Hypertension PDC ≥ 80% as of selection | Count of Participants | Participants |
|
| Baseline Mailing + Dynamic 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). |
| OG002 | Baseline Mailing + 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. |
| OG003 | Baseline Mailing + 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. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| OG004 | Processing Fluency + Dynamic 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. Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| OG005 | 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. Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." |
| OG006 | No Mailing (Usual Care) | Participants randomized to this arm will not receive any mailed message. |
|
|
| Secondary | Proportion of Participants With End-of-year PDC≥80% | As measured by the Proportion of Days Covered metric [PDC] | Posted | Count of Participants | Participants | approximately 4 months |
|
|
|
| 0 |
| 9,198 |
| 0 |
| 9,198 |
| 0 |
| 9,198 |
| EG001 | Baseline Mailing + Dynamic 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). | 0 | 9,180 | 0 | 9,180 | 0 | 9,180 |
| EG002 | Baseline Mailing + 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. Scorecard: Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. | 0 | 9,180 | 0 | 9,180 | 0 | 9,180 |
| EG003 | Baseline Mailing + 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. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." | 0 | 9,193 | 0 | 9,193 | 0 | 9,193 |
| EG004 | Processing Fluency + Dynamic 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. Social norms: Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." | 0 | 9,179 | 0 | 9,179 | 0 | 9,179 |
| EG005 | 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. Messenger effects: Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Processing fluency: Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." | 0 | 9,177 | 0 | 9,177 | 0 | 9,177 |
| EG006 | No Mailing (Usual Care) | Participants randomized to this arm will not receive any mailed message. | 0 | 9,183 | 0 | 9,183 | 0 | 9,183 |
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| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |