Pragmatic trial evaluating the impact of simulation training on high-risk prescribing to older adults by junior physicians.

BACKGROUND: High-risk medications like benzodiazepines, sedative hypnotics, and antipsychotics are commonly prescribed for hospitalized older adults, despite guidelines recommending avoidance. Prior interventions have not fully addressed how physicians make such prescribing decisions, particularly when experiencing stress or cognitive overload. Simulation training may help improve prescribing decision-making but has not been evaluated for overprescribing. METHODS: In this two-arm pragmatic trial, we randomized 40 first-year medical resident physicians (i.e., interns) on inpatient general medicine services at an academic medical center to either intervention (a 40-minute immersive simulation training) or control (online educational training) groups. The primary outcome was the number of new benzodiazepine, sedative hypnotic, or antipsychotic orders for treatment-naïve older adults during hospitalization. Secondary outcomes included the same outcome by all providers, being discharged on one of the medications, and orders for related or control medications. Outcomes were measured using electronic health record data over each intern's service period (~2 weeks). Outcomes were evaluated using generalized estimating equations, adjusting for clustering. RESULTS: In total, 522 treatment-naïve older adult patients were included in analyses. Over follow-up, interns prescribed ≥1 high-risk medication for 13 (4.9%) intervention patients and 13 (5.0%) control patients. The intervention led to no difference in the number of new prescriptions (Rate Ratio [RR]: 0.85, 95%CI: 0.31-2.35) versus control and no difference in secondary outcomes. In secondary analyses, intervention interns wrote significantly fewer "as-needed" ("PRN") order types for the high-risk medications (RR: 0.29, 95%CI: 0.08-0.99), and instead tended to write more "one-time" orders than control interns, though this difference was not statistically significant (RR: 2.20, 95%CI: 0.60-7.99). CONCLUSIONS: Although this simulation intervention did not impact total high-risk prescribing for hospitalized older adults, it did influence how the interns prescribed, resulting in fewer PRN orders, suggesting possibly greater ownership of care. Future interventions should consider this insight and implementation lessons raised. TRIAL REGISTRATION: Clinicaltrials.gov(NCT04668248).

The impact of using reinforcement learning to personalize communication on medication adherence: findings from the REINFORCE trial.

Text messaging can promote healthy behaviors, like adherence to medication, yet its effectiveness remains modest, in part because message content is rarely personalized. Reinforcement learning has been used in consumer technology to personalize content but with limited application in healthcare. We tested a reinforcement learning program that identifies individual responsiveness ("adherence") to text message content and personalizes messaging accordingly. We randomized 60 individuals with diabetes and glycated hemoglobin A1c [HbA1c] ≥ 7.5% to reinforcement learning intervention or control (no messages). Both arms received electronic pill bottles to measure adherence. The intervention improved absolute adjusted adherence by 13.6% (95%CI: 1.7%-27.1%) versus control and was more effective in patients with HbA1c 7.5- < 9.0% (36.6%, 95%CI: 25.1%-48.2%, interaction p < 0.001). We also explored whether individual patient characteristics were associated with differential response to tested behavioral factors and unique clusters of responsiveness. Reinforcement learning may be a promising approach to improve adherence and personalize communication at scale.

Disentangling drug contributions: anticholinergic burden in older adults linked to individual medications: a cross-sectional population-based study.

BACKGROUND: Medications with potent anticholinergic properties have well-documented adverse effects. A high cumulative anticholinergic burden may arise from the concurrent use of multiple medications with weaker anticholinergic effects. We sought to identify patterns of high anticholinergic burden and associated patient characteristics. METHODS: We identified patients aged ≥ 65 who filled ≥ 1 medication with anticholinergic adverse effects in 2019 and had a cumulative Anticholinergic Burden score (ACB) ≥ 4 (i.e., high anticholinergic burden) in a large US health insurer. We classified patients based on how they attained high burden, as follows: 1) only filling strong or moderate anticholinergic medications (i.e., ACB = 2 or 3, "moderate/strong"), 2) only filling lightly anticholinergic medications (i.e., ACB = 1, "light/possible"), and 3) filling any combination ("mix"). We used multinomial logistic regression to assess the association between measured patient characteristics and membership in the three anticholinergic burden classifications, using the moderate/strong group as the referent. RESULTS: In total, 83,286 eligible patients with high anticholinergic burden were identified (mean age: 74.3 years (SD:7.1), 72.9% female). Of these, 4.5% filled only strong/moderate anticholinergics, 4.3% filled only light/possible anticholinergics, and the rest filled a mix (91.2%). Within patients in the mixed group, 64.3% of medication fills were for light/possible anticholinergics, while 35.7% were for moderate/strong anticholinergics. Compared with patients in the moderate/strong anticholinergics group, patients filling only light/possible anticholinergics were more likely to be older (adjusted Odds Ratio [aOR] per 1-unit of age: 1.06, 95%CI: 1.05-1.07), less likely to be female (aOR: 0.56, 95%CI: 0.50-0.62 vs. male), more likely to have comorbidities (e.g., heart failure aOR: 3.18, 95%CI: 2.70-3.74 or depression aOR: 1.20, 95%CI: 1.09-1.33 vs. no comorbidity), and visited fewer physicians (aOR per 1-unit of change: 0.98, 95%CI: 0.97-0.98). Patients in the mixed group were older (aOR per 1-unit of age: 1.02, 95%CI: 1.02-1.03) and less likely to be female (aOR: 0.89, 95%CI: 0.82-0.97 vs. male) compared with those filling moderate/strong anticholinergics. CONCLUSION: Most older adults accumulated high anticholinergic burden through a combination of light/possible and moderate/strong anticholinergics rather than moderate/strong anticholinergics, with light/possible anticholinergics being the major drivers of overall anticholinergic burden. These insights may inform interventions to improve prescribing in older adults.

Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial.

BACKGROUND: Clinical inertia, or failure to intensify treatment when indicated, leads to suboptimal blood pressure control. Interventions to overcome inertia and increase antihypertensive prescribing have been modestly successful in part because their effectiveness varies based on characteristics of the provider, the patient, or the provider-patient interaction. Understanding for whom each intervention is most effective could help target interventions and thus increase their impact. METHODS: This three-arm, randomized trial tests the effectiveness of 2 interventions to reduce clinical inertia in hypertension prescribing compared to usual care. Forty five primary care providers (PCPs) caring for patients with hypertension in need of treatment intensification completed baseline surveys that assessed behavioral traits and were randomized to one of three arms: 1) Pharmacist e-consult, in which a clinical pharmacist provided patient-specific recommendations for hypertension medication management to PCPs in advance of upcoming visits, 2) Social norming dashboards that displayed PCP's hypertension control rates compared to those of their peers, or 3) Usual care (no intervention). The primary outcome was the rate of intensification of hypertension treatment. We will compare this outcome between study arms and then evaluate the association between characteristics of providers, patients, their clinical interactions, and intervention responsiveness. RESULTS: Forty-five primary care providers were enrolled and randomized: 16 providers and 173 patients in the social norming dashboards arm, 15 providers and 143 patients in the pharmacist e-consult arm, and 14 providers and 150 patients in the usual care arm. On average, the mean patient age was 64 years, 47% were female, and 73% were white. Baseline demographic and clinical characteristics of patients were similar across arms, with the exception of more Hispanic patients in the usual care arm and fewest in the pharmacist e-consult arm. CONCLUSIONS: This study can help identify interventions to reduce inertia in hypertension care and potentially identify the characteristics of patients, providers, or patient-provider interactions to understand for whom each intervention would be most beneficial. TRIAL REGISTRATION: Clinicaltrials.gov (NCT, Registered: NCT04603560).

"How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial.

BACKGROUND: Messages aimed at increasing uptake of vaccines have been modestly successful, perhaps in part because they often focus on why individuals should receive a vaccine. Construal Level Theory posits that messages emphasizing "how" to get a vaccine may be more effective at encouraging vaccination than emphasizing "why." This message framing may be particularly important for COVID-19 booster acceptance. OBJECTIVE: To determine if pre-visit patient portal messages designed using Construal Level Theory increase rates of COVID-19 booster vaccination. DESIGN AND INTERVENTIONS: This 3-arm randomized trial was conducted across three large, diverse primary care clinics in Massachusetts between February and May 2022, testing the impact of "how" versus "why" framed pre-visit messages versus no messages ("usual care"). Messages were sent by patient portal two business days before a visit. PARTICIPANTS: Adults with upcoming primary care visits who had electronic health record evidence of receiving their initial COVID-19 vaccination series but not a booster dose. MAIN MEASURES: Receipt of a COVID-19 booster vaccination after the message was sent through the visit date (primary outcome) or 6 weeks (secondary outcome). KEY RESULTS: A total of 3665 patients were randomized (mean age: 53.5 years (SD: 17.3), 59% female, 65.2% White, 26.6% Hispanic), with 1249 to "how" 1199 to "why," and 1217 to usual care arms. Except for clinic and preferred language, characteristics were well balanced across arms. Rates of COVID-19 booster were 13.6% (usual care), 11.7% ("how") (odds ratio (OR) "how" vs usual care: 0.87, 95%CI: 0.67-1.14), and 13.7% ("why") ("why" vs usual care: OR: 1.01, 95%CI: 0.81-1.28). At 6 weeks, "why" outperformed "how" for vaccination (OR: 1.26, 95%CI: 1.06-1.49), with no difference versus usual care. CONCLUSIONS: We found no differences on visit booster receipt after single pre-visit portal messages designed using Construal Level Theory. Further studies to identify effective messaging interventions are needed, especially as additional doses are recommended. CLINICAL TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov, ID: NCT04871776 . Initial release occurred 04/30/2021.

Disagreement between pharmacy claims and direct interview to identify patients with non-adherence to chronic cardiometabolic medications.

BACKGROUND: Accurate methods of identifying patients with suboptimal adherence to cardiometabolic medications are needed, and each approach has benefits and tradeoffs. METHODS: We used data from a large trial of patients with poorly controlled cardiometabolic disease and evidence of medication non-adherence measured using pharmacy claims data whose adherence was subsequently assessed during a telephone consultation with a clinical pharmacist. We then evaluated if the pharmacist assessment agreed with the non-adherence measured using claims. When pharmacist and claims assessments disagreed, we identified reasons why claims were insufficient and used multivariable modified Poisson regression to identify patient characteristics associated with disagreement. RESULTS: Of 1,069 patients identified as non-adherent using claims (proportion of days covered [PDC] <80%), 646 (60.4%) were confirmed as non-adherent on pharmacist interview. For the 423 patients (39.6%) where the interview disagreed with the claims, the most common reasons were paying cash or using an alternate insurance (36.6%), medication discontinuation or regimen change (32.8%), and recently becoming adherent (26.7%). Compared to patients whose claims and interview both showed non-adherence, patients whose interview disagreed with claims were less likely to miss outpatient office visits (RR:0.91, 95%CI:0.85-0.97) and more likely to have a baseline PDC above the median (RR:1.35, 95%CI:1.10-1.64). CONCLUSIONS: Among patients identified as non-adherent by claims, 39.6% were observed to be adherent when assessed during pharmacist consultation. This discrepancy was largely driven by paying out-of-pocket, using alternative insurance, or medication discontinuation or change. These findings have important implications for using pharmacy claims to identify and intervene upon medication non-adherence.

Clinicians' and Patients' 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.

Reducing ethnic and racial disparities by improving undertreatment, control, and engagement in blood pressure management with health information technology (REDUCE-BP) hybrid effectiveness-implementation pragmatic trial: Rationale and design.

BACKGROUND: While racial/ethnic disparities in blood pressure control are documented, few interventions have successfully reduced these gaps. Under-prescribing, lack of treatment intensification, and suboptimal follow-up care are thought to be central contributors. Electronic health record (EHR) tools may help address these barriers and may be enhanced with behavioral science techniques. OBJECTIVE: To evaluate the impact of a multicomponent behaviorally-informed EHR-based intervention on blood pressure control. TRIAL DESIGN: Reducing Ethnic and racial Disparities by improving Undertreatment, Control, and Engagement in Blood Pressure management with health information technology (REDUCE-BP) (NCT05030467) is a two-arm cluster-randomized hybrid type 1 pragmatic trial in a large multi-ethnic health care system. Twenty-four clinics (>350 primary care providers [PCPs] and >10,000 eligible patients) are assigned to either multi-component EHR-based intervention or usual care. Intervention clinic PCPs will receive several EHR tools designed to reduce disparities delivered at different points, including a: (1) dashboard of all patients visible upon logging on to the EHR displaying blood pressure control by race/ethnicity compared to their PCP peers and (2) set of tools in an individual patient's chart containing decision support to encourage treatment intensification, ordering home blood pressure measurement, interventions to address health-related social needs, default text for note documentation, and enhanced patient education materials. The primary outcome is patient-level change in systolic blood pressure over 12 months between arms; secondary outcomes include changes in disparities and other clinical outcomes. CONCLUSION: REDUCE-BP will provide important insights into whether an EHR-based intervention designed using behavioral science can improve hypertension control and reduce disparities.

Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial.

Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.

Prescribing decision making by medical residents on night shifts: A qualitative study.

INTRODUCTION: Prescribing of medications with well-known adverse effects, like antipsychotics or benzodiazepines, during hospitalisation is extremely common despite guideline recommendations against their use. Barriers to optimal prescribing, including perceived pressure from allied health professionals and fatigue, may be particularly pronounced for less experienced medical residents, especially during night shifts when these medications are often prescribed. Under these circumstances, physicians may be more likely to use 'quick', often referred to as System 1 choices, rather than 'considered' System 2 strategies for decisions. Understanding how medical residents use, these different cognitive approaches could help develop interventions to improve prescribing. METHODS: To understand decision-making and contextual contributors that influence suboptimal prescribing during night coverage by medical residents, we conducted semi-structured qualitative interviews with residents in general medicine inpatient settings. The interviews elicited perspectives on shift routines, stressful situations, factors influencing prescribing decision making and hypothetical measures that could improve prescribing. Interviews were audio-recorded and transcribed. Data were analysed using codes developed by the team to generate themes using immersion/crystallisation approaches. RESULTS: We conducted interviews with 21 medical residents; 47% were female, 43% were White, and 43% were Asian. We identified five key themes: (i) time pressures affecting prescribing decisions, (ii) fears of judgement by senior physicians and peers and being responsible for patient outcomes, (iii) perceived pressure from nursing staff, amplified by nurses' greater experience, (iv) clinical acuity as a key factor influencing prescribing, and (v) strategies to improve communication between members of the care team, like ensuring adequate hand-off by day teams. CONCLUSION: Medical residents highlighted numerous contextual factors that promote quick thinking rather than slower thinking when prescribing on night shifts, particularly time constraints, perceived pressure and patient clinical acuity. Interventions aimed at reducing prescribing should address how to manage stress and perceived pressure in decision making.

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

BACKGROUND: Gaps 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. OBJECTIVE: This 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. METHODS: In 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. RESULTS: Recruitment of interns began on March 29, 2021. Recruitment for the trial ended in Q42021, with follow-up completed by Q12022. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT04668248; https://clinicaltrials.gov/ct2/show/NCT04668248. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31464.

Association Between Cost-Saving Prescription Policy Changes and Adherence to Chronic Disease Medications: an Observational Study.

BACKGROUND: Pharmacy benefit design is one tool for improving access and adherence to medications for the management of chronic disease. OBJECTIVE: We assessed the effects of pharmacy benefit design programs, including a change in pharmacy benefit manager (PBM), institution of a prescription out-of-pocket maximum, and a mandated switch to 90 days' medication supply, on adherence to chronic disease medications over time. DESIGN: We used a difference-in-differences design to assess changes in adherence to chronic disease medications after the transition to new prescription policies. SUBJECTS: We utilized claims data from adults aged 18-64, on ≥ 1 medication for chronic disease, whose insurer instituted the prescription policies (intervention group) and a propensity score-matched comparison group from the same region. MAIN MEASURES: The outcome of interest was adherence to chronic disease medications measured by proportion of days covered (PDC) using pharmacy claims. KEY RESULTS: There were 13,798 individuals in each group after propensity score matching. Compared to the matched control group, adherence in the intervention group decreased in the first quarter of 2015 and then increased back to pre-intervention trends. Specifically, the change in adherence compared to the last quarter of 2014 in the intervention group versus controls was - 3.6 percentage points (pp) in 2015 Q1 (p < 0.001), 0.65 pp in Q2 (p = 0.024), 1.1 pp in Q3 (p < 0.001), and 1.4 pp in Q4 (p < 0.001). CONCLUSIONS: In this cohort of commercially insured adults on medications for chronic disease, a change in PBM accompanied by a prescription out-of-pocket maximum and change to 90 days' supply was associated with short-term disruptions in adherence followed by return to pre-intervention trends. A small improvement in adherence over the year of follow-up may not be clinically significant. These findings have important implications for employers, insurers, or health systems wishing to utilize pharmacy benefit design to improve management of chronic disease.

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' 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's 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).

Exploring patient experiences coping with using multiple medications: a qualitative interview study.

OBJECTIVE: Long-term adherence to evidence-based medications in cardiometabolic diseases remains poor, despite extensive efforts to develop and test interventions and deploy clinician performance incentives. The limited success of interventions may be due to ignored factors such as patients' experience of medication-taking. Despite being potentially addressable by clinicians, these factors have not been sufficiently explored, which is particularly important as patients use increasing numbers of medications. The aim is to explore patient perspectives on medication-taking, medication properties that are barriers to adherence, and coping strategies for their medication regimen. DESIGN: Individual, in-person, semistructured qualitative interviews. SETTING: Urban healthcare system. PARTICIPANTS: Twenty-six adults taking ≥2 oral medications for diabetes, hypertension or hyperlipidaemia with non-adherence. Interviews were digitally recorded and transcribed. Data were analysed using developed codes to generate themes. Representative quotations were selected to illustrate themes. RESULTS: Participants' mean age was 55 years, 46% were female and 39% were non-white. Six key themes were identified: (1) medication-taking viewed as a highly inconvenient action (that patients struggle to remember to do); (2) negative implications because of inconvenience or illness perceptions; (3) actual medication regimens can deviate substantially from prescribed regimens; (4) certain medication properties (especially size and similar appearance with others) may contribute to adherence deviations; (5) development of numerous coping strategies to overcome barriers and (6) suggestions to make medication-taking easier (including reducing drug costs, simplifying regimen or dosing frequency and creating more palatable medications). CONCLUSION: Patients with poor adherence often find taking prescription medications to be undesirable and take them differently than prescribed in part due to properties of the medications themselves and coping strategies they have developed to overcome medication-taking challenges. Interventions that reduce the inconvenience of medication use and tailor medications to individual needs may be a welcome development.

Randomised controlled trial targeting habit formation to improve medication adherence to daily oral medications in patients with gout.

INTRODUCTION: Medication adherence for patients with chronic conditions such as gout, a debilitating form of arthritis that requires daily medication to prevent flares, is a costly problem. Existing interventions to improve medication adherence have only been moderately effective. Habit formation theory is a promising strategy to improve adherence. The cue-reward-repetition principle posits that habits are formed by repeatedly completing an activity after the same cue and having the action rewarded every time. Over time, cues become increasingly important whereas rewards become less salient because the action becomes automatic. Leveraging the cue-reward-repetition principle could improve adherence to daily gout medications. METHODS AND ANALYSIS: This three-arm parallel randomised controlled trial tests an adaptive intervention that leverages the repetition cue-reward principle. The trial will began recruitment in August 2021 in Boston, Massachusetts, USA. Eligible patients are adults with gout who have been prescribed a daily oral medication for gout and whose most recent uric acid is above 6 mg/dL. Participants will be randomised to one of three arms and given electronic pill bottles. In the two intervention arms, participants will select a daily activity to link to their medication-taking (cue) and a charity to which money will be donated every time they take their medication (reward). Participants in Arm 1 will receive reminder texts about their cue and their charity reward amount will be US$0.50 per day of medication taken. Arm 2 will be adaptive; participants will receive a US$0.25 per adherent-day and no reminder texts. If their adherence is <75% 6 weeks postrandomisation, their reward will increase to US$0.50 per adherent-day and they will receive reminder texts. The primary outcome is adherence to gout medications over 18 weeks. ETHICS AND DISSEMINATION: This trial has ethical approval in the USA. Results will be published in a publicly accessible peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04776161.

Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.

BACKGROUND: Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. METHODS: The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DISCUSSION: The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. TRIAL REGISTRATION NUMBER: NCT03083886.