Abstract
BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.
Highlights
Half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs
Interventions to improve adherence, such as patient education, reminders, pharmacist support, and financial incentives, have produced mixed results—some demonstrating benefits, but many producing small to negative results [9,10,11,12,13,14]
The primary effectiveness outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data
Summary
Half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Up to 50% of patients do not take their cardiovascular (CV) medications as prescribed [1,2,3,4,5,6], resulting in increased morbidity, mortality, and healthcare costs [4, 7, 8]. Interventions to improve adherence, such as patient education, reminders, pharmacist support, and financial incentives, have produced mixed results—some demonstrating benefits, but many producing small to negative results [9,10,11,12,13,14]. Principles of behavioral economics have been incorporated into health interventions to “nudge” people to achieve improved health outcomes [15]. A prior study testing financial incentives through elimination of copayments for cardiovascular medications in the year after acute myocardial infarction improved adherence by 4 to 6%; financial incentives are not generalizable and are unlikely to be sustainable [10, 16]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
