The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial.

BACKGROUND: Nearly 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. METHODS: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT03973931 . Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Colorado Medical Students' Attitudes and Beliefs About Marijuana.

BACKGROUND: Over the past two decades, state and local governments across the U.S. have been increasingly reforming marijuana laws. Despite growing support for marijuana as a medical treatment, little is known about medical students' perceptions of marijuana use. OBJECTIVE: To assess Colorado medical students' personal and professional opinions on current and future marijuana use in a healthcare setting. DESIGN: A voluntary, anonymous, online cross-sectional survey. PARTICIPANTS: Medical students (n = 624) at the University of Colorado School of Medicine between January and February 2014 were invited to participate. MAIN MEASURES: Numerical responses were quantified using counts and percentages, and Likert scale responses were collapsed for bivariate analysis. Items were gathered thematically and additively scored for each subscale. Internal consistency reliability statistics were calculated for each subscale to ensure that items were assessing similar constructs. Unadjusted t tests and one-way analysis of variance (ANOVA) were used to calculate mean differences in subscale scores between subgroups. KEY RESULTS: We received 236 responses (37%). Students indicated support for marijuana legalization (64%), and few believed that physicians should be penalized for recommending marijuana to patients (6%). Nearly all (97%) believed that further marijuana research should be conducted, and believed marijuana could play a role in the treatment of various medical conditions. Seventy-seven percent reported that they believed marijuana use had the potential for psychological harm, and 68% indicated concern for potential physical harm. Only a minority of students would recommend marijuana to a patient under current law (29%), or if it were legally available (45%). Acceptability of marijuana for treatment of approved conditions was not correlated with age or gender, but was positively correlated with living in Colorado prior to medical school (p < 0.001) and with prior marijuana use (p < 0.001). CONCLUSIONS: Medical students support marijuana legal reform, medicinal uses of marijuana, and increased research, but have concerns regarding risks of marijuana use, and appear hesitant to recommend marijuana to patients.