Introduction
Low medication adherence is problematic.1 Well-designed reminders can increase adherence,2 but when should reminders be sent to maximize impact? Prior observational studies3 and laboratory experiments4 have shown that engagement in healthy activities increases considerably following “fresh-start” dates—life and calendar events signaling the beginning of new cycles (e.g. birthdays or New Year’s).3,4 Extending this insight, we conducted the first randomized controlled trial (RCT) examining whether sending medication adherence reminders around fresh-start dates and highlighting these dates as an opportunity for positive changes could boost reminders’ effectiveness.
Methods
Between January 21 and March 25, 2015, after institutional review board waiver of informed consent, we mailed reminders to 15,011 participants (45% male; 40%−80% adherence in the past 12 months) with commercial or Medicare Advantage insurance with Humana, encouraging them to regularly take their cholesterol, diabetes, or blood pressure medications. Participants were randomly assigned to one of five mailing conditions (Figure 1). In the Birthday Unframed and Birthday Framed conditions, reminders were sent within one week before each participant’s birthday. In the New Year Unframed and New Year Framed conditions, reminders were sent three weeks after New Year’s Day. Reminders in the Birthday Framed and New Year Framed conditions highlighted the participants’ birthday or New Year’s Day, respectively, as an opportunity to make a fresh start and begin taking medications regularly. In the Control condition, reminders without any reference to fresh-start dates were sent on a randomly selected day that was at least one month after New Year’s Day and one week away from the participant’s birthday.
Figure 1.
Flow of Study Participants
For each participant, we used pharmacy claims data to calculate the proportion of days covered (PDC) during our 90-day post-mailing observation period, defined as the number of days he/she had any pills in the medication category listed on his/her reminder divided by 90 days. Ordinary least squares regressions to estimate treatment effects in STATA, version 14 (StataCorp) had an 80% power to detect a difference of at least 2 percentage points between the Control and each treatment condition with α=.05.
Results
Mean PDC among participants was 63.3% over 90 days post-mailing. Compared to the Control condition, PDCs did not significantly differ in the Birthday Unframed (95% confidence interval [CI] of the difference [−1.08, 2.20]), Birthday Framed (95% CI [−1.09, 2.19]), New Year Unframed (95% CI [−0.32, 2.95]), or New Year Framed condition (95% CI [−1.26, 2.03]). The difference in PDCs was also insignificant comparing the Birthday Unframed and Birthday Framed conditions (95% CI [−1.63, 1.66]) or the New Year Unframed and New Year Framed conditions (95% CI [−2.57, 0.71]). Figure 2 depicts these results.
Figure 2.
Ordinary Least Squares (OLS) Regression-Adjusted PDCs by Different Mailing Conditions
Discussion
Contrary to our expectations, sending reminders following fresh-start dates did not increase medication adherence, and fresh-start-based framing did not increase reminder effectiveness. We encourage further study before concluding that the psychology of fresh starts does not apply to medication adherence. Since fresh-start dates motivate individuals wishing to initiate goal pursuit,3,4 our timing- and framing-based treatments may increase the effectiveness of reminders when reminders involve goal-setting activities. Additionally, there is often a delay between a target fresh-start date and the date when treatment-condition reminders were actually received; in the New Year conditions, reminders often arrived in late January. Reminders received immediately after the target date could be more impactful. Further investigation into alternative ways to leverage fresh starts5 and compel patients to attend to public health messaging would be valuable.
This study has several limitations. The insurer sent some customers medication adherence reminders outside of the RCT, and we were unable to include a condition without reminders. Also, many participants were involved in another RCT comparing reminders that ended shortly before this RCT. Further, our participants had lower medication adherence levels than those in other recent adherence studies, possibly because of our selection criteria.6
Acknowledgements
Funding/Support: This research was funded by research grants from Humana.
Role of the Funder/Sponsor: The funding organization, in collaboration with the academic investigators, provided input on the design and conduct of the study; oversaw the collection and management of the data; and contributed to the preparation, review, and approval of the manuscript, as well as the decision to submit the manuscript for publication. The funding organization had no role in the analysis or interpretation of the data.
Footnotes
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Dai reports funding in part by grants from Humana during the conduct of the study. Mr Mao reports funding in part by grants from Humana during the conduct of the study. Dr Volpp reports grants from Humana during the conduct of the study; grants from Hawaii Medical Services Agency, Discovery (South Africa), Merck, Weight Watchers, and CVS outside of the submitted work; he has received consulting income from CVS and VALHealth and is a principal in VALHealth, a behavioral economics consulting form. Mr Relish reports employment by Humana, the funding organization, during the course of the study. Dr Lawnicki reports employment by Humana, the funding organization, during the course of the study. Dr Milkman reports grants from Humana during the conduct of the study; personal fees from Health Prize Academic Advisory Board, outside the submitted work. No other disclosures were reported.
Trial registry name: Fresh Start Experiment
Registration identification number: NCT02411032
URL for the registry: https://clinicaltrials.gov/ct2/show/NCT02411032
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