Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol

Background: The prescribing of high-risk medications to older adults remains extremely common and results in potentially avoidable health consequences. Efforts to reduce prescribing have had limited success, in part because they have been sub-optimally timed, poorly designed, or not provided actionable information. Electronic health record (EHR)-based tools are commonly used but have had limited application in facilitating deprescribing in older adults. The objective is to determine whether designing EHR tools using behavioral science principles reduces inappropriate prescribing and clinical outcomes in older adults. Methods: The Novel Uses of Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) project uses a two-stage, 16-arm adaptive randomized pragmatic trial with a “pick-the-winner” design to identify the most effective of many potential EHR tools among primary care providers and their patients ≥ 65 years chronically using benzodiazepines, sedative hypnotic (“Z-drugs”), or anticholinergics in a large integrated delivery system. In stage 1, we randomized providers and their patients to usual care (n = 81 providers) or one of 15 EHR tools (n = 8 providers per arm) designed using behavioral principles including salience, choice architecture, or defaulting. After 6 months of follow-up, we will rank order the arms based upon their impact on the trial’s primary outcome (for both stages): reduction in inappropriate prescribing (via discontinuation or tapering). In stage 2, we will randomize (a) stage 1 usual care providers in a 1:1 ratio to one of the up to 5 most promising stage 1 interventions or continue usual care and (b) stage 1 providers in the unselected arms in a 1:1 ratio to one of the 5 most promising interventions or usual care. Secondary and tertiary outcomes include quantities of medication prescribed and utilized and clinically significant adverse outcomes. Discussion: Stage 1 launched in October 2020. We plan to complete stage 2 follow-up in December 2021. These results will advance understanding about how behavioral science can optimize EHR decision support to improve prescribing and health outcomes. Adaptive trials have rarely been used in implementation science, so these findings also provide insight into how trials in this field could be more efficiently conducted. Trial registration: Clinicaltrials.gov (NCT04284553, registered: February 26, 2020

Preferences for mHealth Technology and Text Messaging Communication in Patients With Type 2 Diabetes: Qualitative Interview Study

BackgroundIndividuals with diabetes need regular support to help them manage their diabetes on their own, ideally delivered via mechanisms that they already use, such as their mobile phones. One reason for the modest effectiveness of prior technology-based interventions may be that the patient perspective has been insufficiently incorporated. ObjectiveThis study aims to understand patients’ preferences for mobile health (mHealth) technology and how that technology can be integrated into patients’ routines, especially with regard to medication use. MethodsWe conducted semistructured qualitative individual interviews with patients with type 2 diabetes from an urban health care system to elicit and explore their perspectives on diabetes medication–taking behaviors, daily patterns of using mobile technology, use of mHealth technology for diabetes care, acceptability of text messages to support medication adherence, and preferred framing of information within text messages to support diabetes care. The interviews were digitally recorded and transcribed. The data were analyzed using codes developed by the study team to generate themes, with representative quotations selected as illustrations. ResultsWe conducted interviews with 20 participants, of whom 12 (60%) were female and 9 (45%) were White; in addition, the participants’ mean glycated hemoglobin A1c control was 7.8 (SD 1.1). Overall, 5 key themes were identified: patients try to incorporate cues into their routines to help them with consistent medication taking; many patients leverage some form of technology as a cue to support adherence to medication taking and diabetes self-management behaviors; patients value simplicity and integration of technology solutions used for diabetes care, managing medications, and communicating with health care providers; some patients express reluctance to rely on mobile technology for these diabetes care behaviors; and patients believe they prefer positively framed communication, but communication preferences are highly individualized. ConclusionsThe participants expressed some hesitation about using mobile technology in supporting diabetes self-management but have largely incorporated it or are open to incorporating it as a cue to make medication taking more automatic and less burdensome. When using technology to support diabetes self-management, participants exhibited individualized preferences, but overall, they preferred simple and positively framed communication. mHealth interventions may be improved by focusing on integrating them easily into daily routines and increasing the customization of content

Clinicians\u27 and patients\u27 perspectives on hypertension care in a racially and ethnically diverse population in primary care

Importance: Hypertension control remains suboptimal, particularly for Black and Hispanic or Latino patients. A need exists to improve hypertension management and design effective strategies to efficiently improve the quality of care in primary care, especially for these at-risk populations. Few studies have specifically explored perspectives on blood pressure management by primary care providers (PCPs) and patients. Objective: To examine clinician and patient perspectives on barriers and facilitators to hypertension control within a racially and ethnically diverse health care system. Design, setting, and participants: This qualitative study was conducted in a large urban US health care system from October 1, 2020, to March 31, 2021, among patients with a diagnosis of hypertension from a racially and ethnically diverse population, for a range of hypertension medication use hypertension control, as well as practicing PCPs. Analysis was conducted between June 2021 and February 2022 using immersion-crystallization methods. Main outcomes and measures: Perspectives on managing blood pressure, including medication adherence and lifestyle, considerations for intensification, and experiences and gaps in using health information technology tools for hypertension, were explored using semistructured qualitative interviews. These cycles of review were continued until all data were examined and meaningful patterns were identified. Results: Interviews were conducted with 30 participants: 15 patients (mean [SD] age, 58.6 [16.2] years; 10 women [67%] and 9 Black patients [60%]) and 15 clinicians (14 PCPs and 1 medical assistant; 8 women [53%]). Eleven patients (73%) had suboptimally controlled blood pressure. Participants reported a wide range of experiences with hypertension care, even within the same clinics and health care system. Five themes relevant to managing hypertension for racially and ethnically diverse patient populations in primary care were identified: (1) difficulty with self-management activities, especially lifestyle modifications; (2) hesitancy intensifying medications by both clinicians and patients; (3) varying the timing and follow-up after changes in medication; (4) variation in blood pressure self-monitoring recommendations and uptake; and (5) limited specific functionality of current health information technology tools. Conclusions and relevance: In this qualitative study of the views of PCPs and patients on hypertension control, the participants felt that more focus should be placed on lifestyle modifications than medications for hypertension, particularly for patients from racial and ethnic minority groups. Participants also expressed concerns about the existing functionality of health information technology tools to support increasingly asynchronous hypertension care. More intentional ways of supporting treatment intensification, self-care, and follow-up care are needed to improve hypertension management for racially and ethnically diverse populations in primary care

Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial

BackgroundGaps between rational thought and actual decisions are increasingly recognized as a reason why people make suboptimal choices in states of heightened emotion, such as stress. These observations may help explain why high-risk medications continue to be prescribed to acutely ill hospitalized older adults despite widely accepted recommendations against these practices. Role playing and other efforts, such as simulation training, have demonstrated benefits to help people avoid decisional gaps but have not been tested to reduce overprescribing of high-risk medications. ObjectiveThis study aims to evaluate the impact of a simulation-based training program designed to address decisional gaps on prescribing of high-risk medications compared with control. MethodsIn this 2-arm pragmatic trial, we are randomizing at least 36 first-year medical resident physicians (ie, interns) who provide care on inpatient general medicine services at a large academic medical center to either intervention (simulation-based training) or control (online educational training). The intervention comprises a 40-minute immersive individual simulation training consisting of a reality-based patient care scenario in a simulated environment at the beginning of their inpatient service rotation. The simulation focuses on 3 types of high-risk medications, including benzodiazepines, antipsychotics, and sedative hypnotics (Z-drugs), in older adults, and is specifically designed to help the physicians identify their reactions and prescribing decisions in stressful situations that are common in the inpatient setting. The simulation scenario is followed by a semistructured debriefing with an expert facilitator. The trial’s primary outcome is the number of medication doses for any of the high-risk medications prescribed by the interns to patients aged 65 years or older who were not taking one of the medications upon admission. Secondary outcomes include prescribing by all providers on the care team, being discharged on 1 of the medications, and prescribing of related medications (eg, melatonin, trazodone), or the medications of interest for the control intervention. These outcomes will be measured using electronic health record data. ResultsRecruitment of interns began on March 29, 2021. Recruitment for the trial ended in Q42021, with follow-up completed by Q12022. ConclusionsThis trial will evaluate the impact of a simulation-based training program designed using behavioral science principles on prescribing of high-risk medications by junior physicians. If the intervention is shown to be effective, this approach could potentially be reproducible by others and for a broader set of behaviors. Trial RegistrationClinicalTrials.gov NCT04668248; https://clinicaltrials.gov/ct2/show/NCT04668248 International Registered Report Identifier (IRRID)PRR1-10.2196/3146

REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): Study protocol of a pragmatic randomised trial

Introduction Achieving optimal diabetes control requires several daily self-management behaviours, especially adherence to medication. Evidence supports the use of text messages to support adherence, but there remains much opportunity to improve their effectiveness. One key limitation is that message content has been generic. By contrast, reinforcement learning is a machine learning method that can be used to identify individuals\u27 patterns of responsiveness by observing their response to cues and then optimising them accordingly. Despite its demonstrated benefits outside of healthcare, its application to tailoring communication for patients has received limited attention. The objective of this trial is to test the impact of a reinforcement learning-based text messaging programme on adherence to medication for patients with type 2 diabetes. Methods and analysis In the REinforcement learning to Improve Non-adherence For diabetes treatments by Optimising Response and Customising Engagement (REINFORCE) trial, we are randomising 60 patients with suboptimal diabetes control treated with oral diabetes medications to receive a reinforcement learning intervention or control. Subjects in both arms will receive electronic pill bottles to use, and those in the intervention arm will receive up to daily text messages. The messages will be individually adapted using a reinforcement learning prediction algorithm based on daily adherence measurements from the pill bottles. The trial\u27s primary outcome is average adherence to medication over the 6-month follow-up period. Secondary outcomes include diabetes control, measured by glycated haemoglobin A1c, and self-reported adherence. In sum, the REINFORCE trial will evaluate the effect of personalising the framing of text messages for patients to support medication adherence and provide insight into how this could be adapted at scale to improve other self-management interventions. Ethics and dissemination This study was approved by the Mass General Brigham Institutional Review Board (IRB) (USA). Findings will be disseminated through peer-reviewed journals, clinicaltrials.gov reporting and conferences. Trial registration number Clinicaltrials.gov (NCT04473326)