Description of patient questions received by clinical pharmacists in the Nudge Study.

PURPOSE: The Nudge Study is a patient level-randomized trial testing different text message medication refill reminders sent to patients assigned to 4 arms: (1) usual care, (2) generic text, (3) optimized text, and (4) optimized text plus chatbot. This report describes the frequency and types of patient questions sent to clinical pharmacists (CPs) following text reminders. METHODS: Patients were enrolled from Denver Health and Hospital Authority (DHHA) and Veterans Affairs Eastern Colorado Health Care System (VA ECHCS) from October 1, 2019, through May 30, 2021. Included patients responded to at least 1 text or interactive voice response (IVR) message. Patients were dichotomized as those who posed at least 1 question to a CP and those who posed no questions. RESULTS: Of the 6,325 patients enrolled in an intervention arm, 3,323 (52.5%) responded to at least 1 text or IVR message, and among those responding, 305 (9.2%) responded with a pharmacist question. Patient factors associated with submitting a CP question included age (45-74 years), enrollment from DHHA, and receipt of the optimized text or optimized text plus chatbot message versus the generic text. Questions to CP were in the following categories: medication related (48.2%), refill logistics (38.4%), cost (9.2%), and other (17.7%). CONCLUSION: In a text messaging intervention focused on medication refills, there were few questions directed to the CP. Patients assigned to receive optimized texts were more likely to have questions. We hypothesize that this may suggest greater patient engagement regarding their condition, resulting in more questions.

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.

Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews.

Almost 50% of patients with cardiovascular diseases face challenges in taking medications and increased morbidity and mortality. Text messaging may impact medication refill behavior and can be delivered at scale to patients by texting mobile phones. To obtain feedback from persons with chronic conditions on the design of interactive text messages and determine language of message for making messages that can motivate patients to refill medications on time. We purposively sampled 35 English and Spanish speaking patients with at least one chronic condition from three large healthcare delivery systems to participate in N-of-1 video-based synchronous interviews. Research assistants shared ideas for theory-informed text messages with content intended to persuade patients to refill their medication. We transcribed recorded interviews and conducted a content analysis to identify strategies to employ generating a dynamic interactive text message library intended to increase medication refill. Those interviewed were of diverse age and race/ethnicity and typical of persons with multiple chronic conditions. Several participants emphasized that personally tailored and positively framed messages would be more persuasive than generic and/or negative messages. Some patients appreciated humor and messages that could evoke a sense of social support from their providers and rejected the use of emojis. Messages to remind patients to refill medications may facilitate improvements in adherence, which in turn can improve chronic care. Designing messages that are persuasive and can prompt action is feasible and should be considered given the ease with which such messages can be delivered automatically at scale.

Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study.

BACKGROUND: Medication refill behavior in patients with cardiovascular diseases is suboptimal. Brief behavioral interventions called Nudges may impact medication refill behavior and can be delivered at scale to patients using text messaging. METHODS: Patients who were prescribed and filled at least one medication for hypertension, hyperlipidemia, diabetes, atrial fibrillation, and coronary artery disease were identified for the pilot study. Patients eligible for the pilot (N=400) were enrolled with an opportunity to opt out. In phase I of the pilot, we tested text message delivery to 60 patients. In phase II, we tested intervention feasibility by identifying those with refill gap of ≥7 days and randomized them to intervention or control arms. Patients were texted Nudges and assessed whether they refilled their medications. RESULTS: Of 400 patients sent study invitations, 56 (14%) opted out. In phase I, we successfully delivered text messages to 58 of 60 patients and captured patient responses via text. In phase II, 207 of 286 (72.4%) patients had a medication gap ≥7 days for one or more cardiovascular medications and were randomized to intervention or control. Enrolled patients averaged 61.7 years old, were primarily male (69.1%) and White (72.5%) with hypertension being the most prevalent qualifying condition (78.7%). There was a trend towards intervention patients being more likely to refill at least 1 gapping medication (30.6% versus 18.0%; P=0.12) and all gapping medications (17.8% versus 10.0%; P=0.27). CONCLUSIONS: It is possible to set up automated processes within health care delivery systems to identify patients with gaps in medication adherence and send Nudges to facilitate medication refills. Text message Nudges could potentially be a feasible and effective method to facilitate medication refills. A large multi-site randomized trial to determine the impact of text-based Nudges on overall CVD morbidity and mortality is now underway to explore this further. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03973931.