Trial Outcomes & Findings for Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence (NCT NCT06066541)

NCT ID: NCT06066541

Last Updated: 2025-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65177 participants

Primary outcome timeframe

approximately 4 months

Results posted on

2025-01-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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."
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).
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.
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."
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."
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."
No Mailing (Usual Care)
Participants randomized to this arm will not receive any mailed message.
Enrollment Wave 1 (August 18, 2023)
STARTED
8571
8571
8571
8571
8571
8571
8571
Enrollment Wave 1 (August 18, 2023)
COMPLETED
8464
8449
8443
8461
8446
8448
8448
Enrollment Wave 1 (August 18, 2023)
NOT COMPLETED
107
122
128
110
125
123
123
Enrollment Wave 2 (August 24, 2023)
STARTED
740
740
740
740
740
740
740
Enrollment Wave 2 (August 24, 2023)
COMPLETED
734
731
737
732
733
729
735
Enrollment Wave 2 (August 24, 2023)
NOT COMPLETED
6
9
3
8
7
11
5

Reasons for withdrawal

Reasons for withdrawal
Measure
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."
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).
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.
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."
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."
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."
No Mailing (Usual Care)
Participants randomized to this arm will not receive any mailed message.
Enrollment Wave 1 (August 18, 2023)
Excluded due to membership changes
107
122
128
110
125
123
123
Enrollment Wave 2 (August 24, 2023)
Excluded due to membership changes
6
9
3
8
7
11
5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Baseline Mailing (Scorecard)
n=9198 Participants
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."
Baseline Mailing + Dynamic Social Norms
n=9180 Participants
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).
Baseline Mailing + Messenger Effects
n=9180 Participants
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.
Baseline Mailing + Processing Fluency
n=9193 Participants
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."
Processing Fluency + Dynamic Social Norms
n=9179 Participants
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."
Processing Fluency + Messenger Effects
n=9177 Participants
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."
No Mailing (Usual Care)
n=9183 Participants
Participants randomized to this arm will not receive any mailed message.
Total
n=64290 Participants
Total of all reporting groups
Race/Ethnicity, Customized
Other
778 Participants
n=5 Participants
820 Participants
n=7 Participants
808 Participants
n=5 Participants
814 Participants
n=4 Participants
842 Participants
n=21 Participants
845 Participants
n=8 Participants
829 Participants
n=8 Participants
5736 Participants
n=24 Participants
Race/Ethnicity, Customized
Unknown
309 Participants
n=5 Participants
306 Participants
n=7 Participants
325 Participants
n=5 Participants
324 Participants
n=4 Participants
320 Participants
n=21 Participants
289 Participants
n=8 Participants
307 Participants
n=8 Participants
2180 Participants
n=24 Participants
Age, Continuous
71.36 years
STANDARD_DEVIATION 4.11 • n=5 Participants
71.44 years
STANDARD_DEVIATION 4.09 • n=7 Participants
71.44 years
STANDARD_DEVIATION 4.09 • n=5 Participants
71.33 years
STANDARD_DEVIATION 4.07 • n=4 Participants
71.49 years
STANDARD_DEVIATION 4.10 • n=21 Participants
71.44 years
STANDARD_DEVIATION 4.07 • n=8 Participants
71.50 years
STANDARD_DEVIATION 4.07 • n=8 Participants
71.4 years
STANDARD_DEVIATION 4.10 • n=24 Participants
Sex: Female, Male
Female
4881 Participants
n=5 Participants
5005 Participants
n=7 Participants
5041 Participants
n=5 Participants
4938 Participants
n=4 Participants
5040 Participants
n=21 Participants
4967 Participants
n=8 Participants
4939 Participants
n=8 Participants
34811 Participants
n=24 Participants
Sex: Female, Male
Male
4317 Participants
n=5 Participants
4175 Participants
n=7 Participants
4139 Participants
n=5 Participants
4255 Participants
n=4 Participants
4139 Participants
n=21 Participants
4210 Participants
n=8 Participants
4244 Participants
n=8 Participants
29479 Participants
n=24 Participants
Race/Ethnicity, Customized
White
5882 Participants
n=5 Participants
5914 Participants
n=7 Participants
5822 Participants
n=5 Participants
5837 Participants
n=4 Participants
5903 Participants
n=21 Participants
5900 Participants
n=8 Participants
5879 Participants
n=8 Participants
41137 Participants
n=24 Participants
Race/Ethnicity, Customized
Black
2229 Participants
n=5 Participants
2140 Participants
n=7 Participants
2225 Participants
n=5 Participants
2218 Participants
n=4 Participants
2114 Participants
n=21 Participants
2143 Participants
n=8 Participants
2168 Participants
n=8 Participants
15237 Participants
n=24 Participants
Refill cycle
30-day refill cycle
1965 Participants
n=5 Participants
1962 Participants
n=7 Participants
1961 Participants
n=5 Participants
1977 Participants
n=4 Participants
1974 Participants
n=21 Participants
1972 Participants
n=8 Participants
1975 Participants
n=8 Participants
13786 Participants
n=24 Participants
Refill cycle
90-day refill cycle
7233 Participants
n=5 Participants
7218 Participants
n=7 Participants
7219 Participants
n=5 Participants
7216 Participants
n=4 Participants
7205 Participants
n=21 Participants
7205 Participants
n=8 Participants
7208 Participants
n=8 Participants
50504 Participants
n=24 Participants
Low-Income Subsidy (LIS)/Dual Eligibility Status
Low-Income Subsidy (LIS) Only
497 Participants
n=5 Participants
518 Participants
n=7 Participants
536 Participants
n=5 Participants
514 Participants
n=4 Participants
524 Participants
n=21 Participants
567 Participants
n=8 Participants
566 Participants
n=8 Participants
3722 Participants
n=24 Participants
Low-Income Subsidy (LIS)/Dual Eligibility Status
Medicaid Eligible only
9 Participants
n=5 Participants
7 Participants
n=7 Participants
10 Participants
n=5 Participants
12 Participants
n=4 Participants
16 Participants
n=21 Participants
8 Participants
n=8 Participants
10 Participants
n=8 Participants
72 Participants
n=24 Participants
Low-Income Subsidy (LIS)/Dual Eligibility Status
LIS and Dual Eligible
2407 Participants
n=5 Participants
2364 Participants
n=7 Participants
2289 Participants
n=5 Participants
2396 Participants
n=4 Participants
2330 Participants
n=21 Participants
2294 Participants
n=8 Participants
2296 Participants
n=8 Participants
16376 Participants
n=24 Participants
Low-Income Subsidy (LIS)/Dual Eligibility Status
No LIS/Dual Eligibility
6285 Participants
n=5 Participants
6291 Participants
n=7 Participants
6345 Participants
n=5 Participants
6271 Participants
n=4 Participants
6309 Participants
n=21 Participants
6308 Participants
n=8 Participants
6311 Participants
n=8 Participants
44120 Participants
n=24 Participants
Hypertension proportion of days covered (PDC) as of selection
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=5 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=7 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=5 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=4 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=21 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=8 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=8 Participants
0.77 proportion of days covered (PDC)
STANDARD_DEVIATION 0.06 • n=24 Participants
Hypertension PDC ≥ 80% as of selection
3690 Participants
n=5 Participants
3615 Participants
n=7 Participants
3705 Participants
n=5 Participants
3720 Participants
n=4 Participants
3690 Participants
n=21 Participants
3650 Participants
n=8 Participants
3722 Participants
n=8 Participants
25792 Participants
n=24 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Baseline Mailing (Scorecard)
n=9198 Participants
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."
Baseline Mailing + Dynamic Social Norms
n=9180 Participants
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).
Baseline Mailing + Messenger Effects
n=9180 Participants
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.
Baseline Mailing + Processing Fluency
n=9193 Participants
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."
Processing Fluency + Dynamic Social Norms
n=9179 Participants
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."
Processing Fluency + Messenger Effects
n=9177 Participants
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."
No Mailing (Usual Care)
n=9183 Participants
Participants randomized to this arm will not receive any mailed message.
Average End-of-year Adherence Level
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12
0.81 proportion of days covered
Standard Deviation 0.12

SECONDARY outcome

Timeframe: approximately 4 months

As measured by the Proportion of Days Covered metric \[PDC\]

Outcome measures

Outcome measures
Measure
Baseline Mailing (Scorecard)
n=9198 Participants
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."
Baseline Mailing + Dynamic Social Norms
n=9180 Participants
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).
Baseline Mailing + Messenger Effects
n=9180 Participants
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.
Baseline Mailing + Processing Fluency
n=9193 Participants
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."
Processing Fluency + Dynamic Social Norms
n=9179 Participants
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."
Processing Fluency + Messenger Effects
n=9177 Participants
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."
No Mailing (Usual Care)
n=9183 Participants
Participants randomized to this arm will not receive any mailed message.
Proportion of Participants With End-of-year PDC≥80%
6518 Participants
6590 Participants
6467 Participants
6515 Participants
6558 Participants
6598 Participants
6587 Participants

Adverse Events

Baseline Mailing (Scorecard)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Baseline Mailing + Dynamic Social Norms

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Baseline Mailing + Messenger Effects

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Baseline Mailing + Processing Fluency

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Processing Fluency + Dynamic Social Norms

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Processing Fluency + Messenger Effects

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Mailing (Usual Care)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Niteesh Choudhry, MD, PhD

Brigham and Women's Hospital

Phone: 617-278-0930

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place