Medication AdherenceNCT06066541
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
A study testing Scorecard, Social norms and Messenger effects in people with Medication Adherence and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Medication Adherence, Hypertension
- What is being tested?
- Scorecard, Social norms and Messenger effects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,177 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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%
Who cannot join
- Beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Scorecard, Social norms, Messenger effects, Processing fluency
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScorecardBehavioural
Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."
Social normsBehavioural
Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).
Messenger effectsBehavioural
Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.
Processing fluencyBehavioural
Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Messenger effects; Behavioral: Processing fluency |
| Usual care | No intervention | Participants randomized to this arm will not receive any mailed message. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 4 months
Secondary outcomes (1)
Proportion of Participants With End-of-year PDC≥80%
As measured by the Proportion of Days Covered metric [PDC]
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start18 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Inc., National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Ted Robertson, MPA, Principal investigator, Ideas42Punam Keller, PhD, MBA, Principal investigator, Tuck School of Business at Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066541
- Sponsor's protocol ID
- 2023p002222
- Other IDs
- P30AG064199
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2023
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40366654
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence
- ClinicalTrials.gov ID
- NCT06066541
- Acronym / sponsor ID
- 2023p002222
- Conditions
- Medication Adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65,177 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Humana Inc., National Institute on Aging (NIA)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Scorecard | Active comparator | Behavioral: ScorecardParticipants 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 | Behavioral: Scorecard, Behavioral: Social normsParticipants 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 | Behavioral: Scorecard, Behavioral: Messenger effectsParticipants 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 | Behavioral: Processing fluencyParticipants 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 + Social norms | Experimental | Behavioral: Social norms, Behavioral: Processing fluencyParticipants 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 | Behavioral: Messenger effects, Behavioral: Processing fluencyParticipants 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. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (1 listed)
- Beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScorecardParticipants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score." | Behavioural | Scorecard, Scorecard + Messenger effects, Scorecard + Social norms |
| Social normsParticipants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). | Behavioural | Processing fluency + Social norms, Scorecard + Social norms |
| Messenger effectsParticipants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. | Behavioural | Processing fluency + Messenger effects, Scorecard + Messenger effects |
| Processing fluencyParticipants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." | Behavioural | Processing fluency, Processing fluency + Messenger effects, Processing fluency + Social norms |
Primary outcome
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.
1 secondary outcome
Proportion of Participants With End-of-year PDC≥80%
Time frame: approximately 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40366654Keller 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Robertson, MPA principal investigator
Ideas42
Punam Keller, PhD, MBA principal investigator
Tuck School of Business at Dartmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scorecard, Social norms and Messenger effects in people with Medication Adherence and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average End-of-year Adherence Level (time frame: approximately 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.