Speakers
Michael Ho, MD, PhD
University of Colorado
Sheana Bull, PhD
University of Colorado
Keywords
Nudge, NIH Collaboratory Trial, Cardiovascular, Adherence
Key Points
- A nudge is a strategic reminder that can help people adopt healthy behaviors, using principles from behavioral economics and cognitive psychology to improve behavior commitments, communicate social norms, and narrative stories. The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement.
- The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients. The second aim was to conduct a pilot intervention to demonstrate feasibility of delivering the intervention and preliminary effects in a 3 healthcare systems. The idea was to engage the patient, providers, and healthcare system leaders to design, refine, and implement the pilot.
- In Years 2-5 (UH3 Phase) the aims were to conduct and evaluate a pragmatic patient-level randomized intervention across 3 healthcare systems to improve adherence to chronic cardiovascular (CV) medications. The second aim was to evaluate the intervention effectiveness using a mixed methods approach and apply the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework.
- The study recruited adult patients diagnosed with 1 or more cardiovascular condition of interest, prescribed at least 1 or more medication of interest, with a refill gap of at least 7 days. Patiens were excluded if they had neither a landline or cell phone, were enrolled in hospice or palliative care, were non-English or Spanish speaking, and residing out of the state of Colorado.
- Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics.
- Nudge used an opt out approach, with IRB approval because it was a low-risk intervention and having patients consent on a large scale would be challenging and might bias the sample to more adherent patients. Nudge sent an opt-out packet with an information sheet, an opt-out sheet and a self-addressed stamped envelope. There was also an option to complete a survey to share reasons for opting out. There were 4 weeks to return the opt-out form, and there was a text opt-out option once the program started.
- More than 13,000 patients were considered eligible for the UH3 trial and more than 9,500 were randomized in the 4 arms, with about 2,300 patients in each of the arms. The 4 arms were usual care, generic text message arm, optimized text message arm that used behavioral theories that aligned with “nudge,” and a fourth arm that used a chat bot.
- All of the intervention arms had a significant influence on refills but there was no different between the intervention arms. Patients could text back with clinical questions or questions about the study. About 50% of participants responded with a question, and 9.2% responded with a question for a clinical pharmacist.
- Nudge also deployed a text message and survey to participants to get a sense for patient satisfaction with feedback on the study and text messages. The response rate was low but in general there were high levels of satisfaction with the intervention. No concerns were raised about privacy concerns or confusion about the messages.
- Lessons learned: The text message intervention improved medication refill adherence, the effectiveness was consistent regardless of the type of message delivered, and the differential impact of the intervention across some patient groups. The opt out approach is feasible and drop out rate was lower than expected. Patients were generally satisfied with text messages, and patients who were non-white and Hispanic were more likely to remain in the study. Text messages can be implemented as a low-cost intervention to improve medication refill adherence across different healthcare systems with disperate EHR systems.
Discussion Themes
-Do you think the results support a text message nudge in most clinical trials and what is the cost effectiveness of this? This is a low-cost strategy and would be a great option to use as one of multiple strategies to use in clinical trials. The nudge can be very generally defined, the timing of the message for this kind of intervention is important. It’s not clear that this messaging may not be sufficient for other types of behavior, like changing diet, but for this type of action it was sufficient.
-What was your IRB? Our IRB was the Colorado Multiple Institutional review board. Messages included PHI but the study followed the institutional security protocols that allowed the intervention to be approved.
–How did the messages account for prescription dosage changes? Patients could reply with Done and the message reminders would stop. The study would then recalculate the gaps.
Tags
#pctGR, @Collaboratory1