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.

Measuring vaccine hesitancy: Field testing the WHO SAGE Working Group on Vaccine Hesitancy survey tool in Guatemala.

BACKGROUND: Despite safe and effective childhood immunizations, decreased acceptance of vaccines has become an emerging global problem. The WHO SAGE Working Group on Vaccine Hesitancy developed a common diagnostic tool, the Vaccine Hesitancy Scale (VHS), to identify and compare hesitancy in different global settings. We field tested the VHS in rural and urban Guatemala. METHODS: We analyzed data from the enrollment visit of a study conducted at four public health clinics in Guatemala. Infants ages 6 weeks-6 months presenting for their first wellness visit were enrolled March-November 2016. Parents completed a demographic survey that included the 10 dichotomous and 10 Likert scale VHS questions. Chi-square or Fisher's exact for categorical and ANOVA test for continuous variables were used to assess significance levels in survey differences. We conducted a factor analysis to assess the Likert scale questions. RESULTS: Of 1088 families screened, 871 were eligible and 720 (82.7%) participated. No parent had ever refused a vaccination, and only eight parents (1.1%) had been reluctant or hesitated to get a vaccination for their children. However, only 40.8% (n = 294) of parents said that they think most parents like them have their children vaccinated with all the recommended vaccines. Factor analysis identified two underlying constructs that had eigenvalues of 1.0 or greater and a substantive lack of variability in response across the Likert scale. There were consistent differences between how study clinics responded to the ordinal scaling. CONCLUSION: Our results suggest problems with interpretation of the VHS, especially in the presence of vaccine shortages and using a Likert scale that does not resonate across diverse cultural settings. Our factor analysis suggests that the Likert scale items are more one-dimensional and do not represent the multiple constructs of vaccine hesitancy. We suggest more work is needed to refine this survey for improved reliability and validity. Clinical Trial Registry: NCT02567006.