Fifer SK, Choundry NK, Brod M, Hsu E, Milstein A. Improving adherence to guidelines for spine pain care: what tools could support primary care clinicians in conforming to guidelines?. BMJ Open Qual 2022;11Abstract
BACKGROUND: Spine pain is one of the most common conditions seen in primary care and is often treated with ineffective, aggressive interventions, such as prescription pain medications, imagery and referrals to surgery. Aggressive treatments are associated with negative side effects and high costs while conservative care has lower risks and costs and equivalent or better outcomes. Despite multiple well-publicised treatment guidelines and educational efforts recommending conservative care, primary care clinicians (PCCs) widely continue to prescribe aggressive, low-value care for spine pain. METHODS: In this qualitative study semistructured interviews were conducted with PCCs treating spine pain patients to learn what prevents clinicians from following guidelines and what tools or support could promote conservative care. Interviews were conducted by telephone, transcribed and coded for thematic analysis. RESULTS: Forty PCCs in academic and private practice were interviewed. Key reflections included that while familiar with guidelines recommending conservative treatment, they did not find guidelines useful or relevant to care decisions for individual patients. They believed that there is an insufficient body of real-world evidence supporting positive outcomes for conservative care and guidance recommendations. They indicated that spine pain patients frequently request aggressive care. These requests, combined with the PCCs' commitment to reaching shared treatment decisions with patients, formed a key reason for pursuing aggressive care. PCCs reported not being familiar with risk-screening tools for spine patients but indicated that such screens might increase their confidence to recommend conservative care to low-risk patients. CONCLUSIONS: PCCs may be more willing to give conservative, guideline-consistent care for spine pain if they had tools to assist in making patient-specific evaluations and in countering requests for unneeded aggressive care. Such tools would include both patient risk screens and shared decision-making aids that include elements for resolving patient demands for inappropriate care.
Powell RJ, Choudhry N, Conte M, Cziraky M, Giles K, Hamza T, Menard M, Rosenfeld K, Rowe V, Siracuse JJ, Strong M, Van Over M, Villarreal M, White C, Farber A. Factors associated with lower preoperative quality of life in patients with chronic limb-threatening ischemia in the BEST-CLI trial. J Vasc Surg 2022;76(6):1642-1650.Abstract
OBJECTIVES: There are few contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, National Institutes of Health-sponsored, multicenter, randomized, controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures Vascular Quality of Life Questionnaire (VascQOL), European Quality of Life 5D (EQ-5D), and the Short Form 12 (SF-12) Index score, physical component score (PCS) and mental component score (MCS) were aggregated from preoperative questionnaires completed by trial patients at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL. RESULTS: We randomized 1830 patients into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ-5D, and SF-12 instruments at baseline, respectively. In the VascQOL, female sex, smoking history, opioid use, and nonindependent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (mean, 3.07 ± 1.2 vs mean, 2.9 ± 1.1; P = .07). In EQ-5D, nonindependent ambulation predicted lower HRQOL scores. In the SF-12, female sex, opioid use, nonindependent ambulation, and a history of smoking predicted lower HRQOL scores. The mean SF-12 PCS for all patients in the study was 33.0 ± 8.5 and for the MCS was 46.4 ± 12.0), significantly lower than the national SF-12 scores for US population ages more than 60 years, which is a PCS of 46.5 ± 11.4 and an MCS of 52.9 ± 8.7. CONCLUSIONS: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores, comparable with patients suffering from other chronic conditions characterized by physical limitations and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in patients with CLI, using multiple HRQOL measurement tools.
Rymer JA, Kaltenbach LA, Peterson ED, Cohen DJ, Fonarow GC, Choudhry NK, Henry TD, Cannon CP, Wang TY. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS. J Am Heart Assoc 2022;11:e026421.Abstract
Background Persistence to P2Y12 inhibitors after myocardial infarction (MI) remains low. Out-of-pocket cost is cited as a factor affecting medication compliance. We examined whether a copayment intervention affected 1-year persistence to P2Y12 inhibitors and clinical outcomes. Methods and Results In an analysis of ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study), patients with MI discharged on a P2Y12 inhibitor were stratified by baseline out-of-pocket medication burden: low ($0-$49 per month), intermediate ($50-$149 per month), and high (≥$150 per month). The impact of the voucher intervention on 1-year P2Y12 inhibitor persistence was examined using a logistic regression model with generalized estimating equations. We assessed the rates of major adverse cardiovascular events among the groups using a Kaplan-Meier estimator. Among 7351 MI-treated patients at 282 hospitals, 54.2% patients were in the low copay group, 32.0% in the middle copay group, and 13.8% in the high copay group. Patients in higher copay groups were more likely to have a history of prior MI, heart failure, and diabetes compared with the low copay group (all P<0.0001). Voucher use was associated with a significantly higher likelihood of 1-year P2Y12 inhibitor persistence regardless of copayment tier (low copay with versus without voucher: adjusted odds ratio [OR], 1.44 [95% CI, 1.25-1.66]; middle copay: adjusted OR, 1.63 [95% CI, 1.37-1.95]; high copay group: adjusted OR, 1.41 [95% CI, 1.05-1.87]; P interaction=0.42). Patients in the high copay group without a voucher had similar risk of 1-year major adverse cardiovascular events compared with patients in the high copay group with a voucher (adjusted hazard ratio, 0.89 [95% CI, 0.66-1.21]). Conclusions Medication copayment vouchers were associated with higher medication persistence at 1 year following an MI, regardless of out-of-pocket medication burden. Registration URL:; Unique identifier: NCT02406677.
Lauffenburger JC, Khatib R, Siddiqi A, Albert MA, Keller PA, Samal L, Glowacki N, Everett ME, Hanken K, Lee SG, Bhatkhande G, Haff N, Sears ES, Choudhry NK. 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. Am Heart J 2022;255:12-21.Abstract
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.
Lauffenburger JC, Choudhry NK, Russo M, Glynn RJ, Ventz S, Trippa L. Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations. BMJ Medicine 2022;1:e000158.Abstract
Randomised controlled clinical trials are widely considered the preferred method for evaluating the efficacy or effectiveness of interventions in healthcare. Adaptive trials incorporate changes as the study proceeds, such as modifying allocation probabilities or eliminating treatment arms that are likely to be ineffective. These designs have been widely used in drug discovery studies but can also be useful in health services and implementation research and have been minimally used. In this article, we use an ongoing adaptive trial and two completed parallel group studies as motivating examples to highlight the potential advantages, disadvantages, and important considerations when using adaptive trial designs in health services and implementation research. We also investigate the impact on power and the study duration if the two completed parallel group trials had instead been conducted using adaptive principles. Compared with traditional trial designs, adaptive designs can often allow the evaluation of more interventions, adjust participant allocation probabilities (eg, to achieve covariate balance), and identify participants who are likely to agree to enrol. These features could reduce resources needed to conduct a trial. However, adaptive trials have potential disadvantages and practical aspects that need to be considered, most notably: outcomes that can be rapidly measured and extracted (eg, long term outcomes that take considerable time to measure from data sources can be challenging), minimal missing data, and time trends. In conclusion, adaptive designs are a promising approach to help identify how best to implement evidence based interventions into real world practice in health services and implementation research.Data are available upon request. Data will be available on reasonable request, pending appropriate agreements and institutional review board approval.
Lauffenburger JC, Coll MD, Kim E, Robertson T, Oran R, Haff N, Hanken K, Avorn J, Choudhry NK. Prescribing decision making by medical residents on night shifts: A qualitative study. Med Educ 2022;56(10):1032-1041.Abstract
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.
Haff N, Choudhry NK, Bhatkhande G, Li Y, Antol DD, Renda A, Lauffenburger JC. Frequency of Quarterly Self-reported Health-Related Social Needs Among Older Adults, 2020. JAMA Netw Open 2022;5(6):e2219645. PDF
Dhand A, Podury A, Choudhry N, Narayanan S, Shin M, Mehl MR. Leveraging Social Networks for the Assessment and Management of Neurological Patients. Semin Neurol 2022;42:136-148.Abstract
Social networks are the persons surrounding a patient who provide support, circulate information, and influence health behaviors. For patients seen by neurologists, social networks are one of the most proximate social determinants of health that are actually accessible to clinicians, compared with wider social forces such as structural inequalities. We can measure social networks and related phenomena of social connection using a growing set of scalable and quantitative tools increasing familiarity with social network effects and mechanisms. This scientific approach is built on decades of neurobiological and psychological research highlighting the impact of the social environment on physical and mental well-being, nervous system structure, and neuro-recovery. Here, we review the biology and psychology of social networks, assessment methods including novel social sensors, and the design of network interventions and social therapeutics.
Alefan Q, Yao S, Taylor JG, Lix LM, Eurich D, Choudhry N, Blackburn DF. Factors associated with early nonpersistence among patients experiencing side effects from a new medication. J Am Pharm Assoc (2003) 2022;62:717-726.e5.Abstract
BACKGROUND: Drug discontinuation (i.e., nonpersistence) is often attributed to the emergence of adverse effects. However, it is not known whether other factors increase the risk of nonpersistence when adverse effects occur. OBJECTIVES: To identify factors associated with early nonpersistence among patients experiencing adverse effects from newly prescribed medications. METHODS: A questionnaire was mailed to new users of antihypertensive, antihyperglycemic, and lipid-lowering medications in Saskatchewan, Canada, between 2019 and 2020. Only respondents experiencing adverse effects were included. Responses were compared between the nonpersistent group (i.e., people who had discontinued their medication) and the persistent group (i.e., those who were taking their medication at the time of the survey). Statistically significant factors were tested in multivariable logistic regression models. Odds ratios (ORs) and 95% CIs were reported. RESULTS: Of the 3973 returned questionnaires, 813 respondents experienced adverse -effects from their new medication and were included in the study. Of these, 143 respondents (17.5%) had stopped their medication at the time of survey completion; most discontinuations (72.1%) occurred within 1 month of the first dose. Nonpersistent patients were older, had lower income, and were less likely to be taking an antihyperglycemic medication. After covariate adjustment, 6 factors were independently associated with nonpersistence: age less than 65 years (OR 1.56 [95% CI 1.01-2.41]), female sex (1.67 [1.08-2.59]), health condition not considered dangerous (2.09 [1.25-3.51]), medication not considered important for health (6.90 [4.40-10.84]), failure to expect adverse effects before starting medication (2.67 [1.74-4.10]), and taking 2 or more medications (0.45 [0.27-0.73]). CONCLUSION: Despite the strong link between the emergence of adverse effects and early nonpersistence, our findings confirm that this association is highly influenced by several factors external to the physical experiences caused by the new medication.
Lauffenburger JC, DiFrancesco MF, Barlev RA, Robertson T, Kim E, Coll MD, Haff N, Fontanet CP, Hanken K, Oran R, Avorn J, Choudhry NK. Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2022;11:e31464.Abstract
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: NCT04668248; INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31464.
Carlile N, Tantillo S, Brown M, Bates DW, Choudhry NK. A novel modality for real-time measurement of provider happiness. JAMIA Open 2022;5:ooac009.Abstract
OBJECTIVE: Physician burnout is at epidemic proportions, impacts clinical outcomes, and is very costly. Although there is emerging data about effective interventions, most physicians at risk of burnout do not seek help. Survey-based measures exist which can quantify burnout within populations, but these are usually only administered episodically. We hypothesized that a novel modality for real-time measurement of happiness and stressors would be acceptable, scalable, and could provide new actionable insights. MATERIALS: We developed a novel informatics system consisting of a networked smart button device, server, and analytics for measuring happiness, and stressors in real-time during clinical work. We performed an observational cohort study in 3 primary care clinics. Random and fixed effects modeling was used to analyze predictors of stress and happiness and we conducted a survey of usability and user acceptance of the novel system. RESULTS: We captured 455 recordings across 392 provider days from 14 primary care providers. In total, 85% of users found the device easy to use, and 87% would recommend the system to their colleagues. Happiness and stressors were observed in all working hours of the day, with a 22% reduction in feeling (the proportion of happiness to stressors) across a clinical day. DISCUSSION: We tested a novel system which providers found easy to use and enabled collection of detailed data. Limitations included being an observational study within a small number of clinics. A simple, unintrusive, scalable informatics system capable of measuring happiness, and stressors in real-time could be useful to healthcare organizations and teams.
Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension 2022;79(1):e1-e14.Abstract
The widespread treatment of hypertension and resultant improvement in blood pressure have been major contributors to the dramatic age-specific decline in heart disease and stroke. Despite this progress, a persistent gap remains between stated public health targets and achieved blood pressure control rates. Many factors may be important contributors to the gap between population hypertension control goals and currently observed control levels. Among them is the extent to which patients adhere to prescribed treatment. The goal of this scientific statement is to summarize the current state of knowledge of the contribution of medication nonadherence to the national prevalence of poor blood pressure control, methods for measuring medication adherence and their associated challenges, risk factors for antihypertensive medication nonadherence, and strategies for improving adherence to antihypertensive medications at both the individual and health system levels.
Powers, B.W.; Dzayich Antol D; ZHGS; RO; SWH; CNKY;. Association between Primary Care Payment Model and Telemedicine Use for Medicare Advantage Enrollees during the COVID-19 Pandemic. JAMA Health Forum 2021;2:e211597. PDF
Becker NV, Bakshi S, Martin KL, Bougrine A, Andrade J, Massey PR, Hirner JP, Eccleston J, Choudhry NK, Britton KA, Landman AB, Licurse AM, Carlile N, Mendu ML. Virtual Team Rounding: A Cross-Specialty Inpatient Care Staffing Program to Manage COVID-19 Surges. Acad Med 2021;96(12):1717-1721.Abstract
PROBLEM: The SARS-CoV-2 (COVID-19) pandemic presented numerous challenges to inpatient care, including overtaxed inpatient medicine services, surges in patient censuses, disrupted patient care and educational activities for trainees, underused providers in certain specialties, and personal protective equipment shortages and new requirements for physical distancing. In March 2020, as the COVID-19 surge began, an interdisciplinary group of administrators, providers, and trainees at Brigham and Women's Hospital created an inpatient virtual staffing model called the Virtual Team Rounding Program (VTRP). APPROACH: The conceptual framework guiding VTRP development was rapid-cycle innovation. The VTRP was designed iteratively using feedback from residents, physician assistants, attendings, and administrators from March to June 2020. The VTRP trained and deployed a diverse set of providers across specialties as "virtual rounders" to support inpatient teams by joining and participating in rounds via videoconference and completing documentation tasks during and after rounds. The program was rapidly scaled up from March to June 2020. OUTCOMES: In a survey of inpatient providers at the end of the pilot phase, 10/10 (100%) respondents reported they were getting either "a lot" or "a little" benefit from the VTRP and did not find the addition of the virtual rounder burdensome. During the scaling phase, the program grew to support 24 teams. In a survey at the end of the contraction phase, 117/187 (62.6%) inpatient providers who worked with a virtual rounder felt the rounder saved them time. VTRP leadership collaboratively and iteratively developed best practices for challenges encountered during implementation. NEXT STEPS: Virtual rounding provides a valuable extension of inpatient teams to manage COVID-19 surges. Future work will quantitatively and qualitatively assess the impact of the VTRP on inpatient provider satisfaction and well-being, virtual rounders' experiences, and patient care outcomes.
Fontanet CP, Choudhry NK, Isaac T, Sequist TD, Gopalakrishnan C, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Lauffenburger JC. Comparison of measures of medication adherence from pharmacy dispensing and insurer claims data. Health Serv Res 2021;:1-13.Abstract
OBJECTIVE: Medication nonadherence is linked to worsened clinical outcomes and increased costs. Existing system-level adherence interventions rely on insurer claims for patient identification and outcome measurement, yet suffer from incomplete capture and lags in data acquisition. Data from pharmacies regarding prescription filling, captured in retail dispensing, may be more efficient. DATA SOURCES: Pharmacy fill and insurer claims data. STUDY DESIGN: We compared adherence measured using pharmacy fill data to adherence using insurer claims data, expressed as proportion of days covered (PDC) over 12 months. Agreement was evaluated using correlation/validation metrics. We also explored the relationship between adherence in both sources and disease control using prediction modeling. DATA EXTRACTION METHODS: Large pragmatic trial of cardiometabolic disease in an integrated delivery network. PRINCIPAL FINDINGS: Among 1113 patients, adherence was higher in pharmacy fill (mean = 50.0%) versus claims data (mean = 47.4%), although they had moderately high correlation (R = 0.57, 95% CI: 0.53-0.61) with most patients (86.9%) being similarly classified as adherent or nonadherent. Sensitivity and specificity of pharmacy fill versus claims data were high (0.89, 95% CI: 0.86-0.91 and 0.80, 95% CI: 0.75-0.85). Pharmacy fill-based PDC predicted better disease control slightly more than claims-based PDC, although the difference was nonsignificant. CONCLUSIONS: Pharmacy fill data may be an alternative to insurer claims for adherence measurement.
Lauffenburger JC, Yom-Tov E, Keller PA, McDonnell ME, Bessette LG, Fontanet CP, Sears ES, Kim E, Hanken K, Buckley JJ, Barlev RA, Haff N, Choudhry NK. REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): study protocol of a pragmatic randomised trial. BMJ Open 2021;11(12):e052091.Abstract
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, reporting and conferences. TRIAL REGISTRATION NUMBER: (NCT04473326).
Fontanet CP, Choudhry NK, Wood W, Robertson T, Haff N, Oran R, Sears ES, Kim E, Hanken K, Barlev RA, Lauffenburger JC, Feldman CH. Randomised controlled trial targeting habit formation to improve medication adherence to daily oral medications in patients with gout. BMJ Open 2021;11(11):e055930.Abstract
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.
Chiu N, Lauffenburger JC, Franklin JM, Choudhry NK. Prevalence, predictors, and outcomes of both true- and pseudo-resistant hypertension in the action to control cardiovascular risk in diabetes trial: a cohort study. Hypertens Res 2021;44(11):1471-1482.Abstract
Resistant hypertension (RH) has been poorly studied due to the difficulty in distinguishing it from nonadherence-the exclusion of which is necessary to accurately diagnose RH. Therefore, little is known about the prevalence, predictors, and outcomes of true RH. We evaluated 1838 patients from the standard blood pressure (BP) arm of the Action to Control Cardiovascular Risk in Diabetes Trial. We classified patients into three groups: "true RH", "pseudo-RH" (i.e., patients with BP levels that would classify them as RH but who were non-adherent), and "other" (i.e., those who could not be classified as having "true RH" or "pseudo-RH"). We examined predictors of true and pseudo-RH and the relationship between true RH and the composite outcome of nonfatal MI, nonfatal stroke, or cardiovascular death. Among 1838 participants with complete information, 489 (26.6%) met the definition of true RH, and 94 (16.1%) RH patients had "pseudo-RH" on ≥1 visit over the first 12 months. Predictors of RH included: baseline SBP ≥ 160 mmHg (OR = 8.79; 95% CI: 5.70-13.68) and baseline SBP between 140-159 (OR = 2.91; 95% CI: 2.13-4.00) compared to SBP < 140, additional baseline BP medication (OR = 3.40; 95% CI: 2.83-4.11), macroalbuminuria (OR = 2.35; 95% CI: 1.50-3.67), CKD (OR = 1.53; 95% CI: 0.99-2.33), history of stroke (OR = 1.73; 95% CI: 1.04-2.82), and black race (OR = 1.39; 95% CI: 1.02-1.88); the cross-validated C-statistic was 0.80. "True RH" patients had a 65% increased hazard in composite outcome (HR = 1.65; 95% CI: 1.13-2.42). In conclusion, the majority of patients classified as having RH had "true RH," which was more common among those who are black, have macroalbuminuria, CKD, stroke, higher baseline SBP, and are taking more baseline antihypertensives. These patients are at increased risk for cardiovascular and mortality events.
Lauffenburger JC, Haff N, McDonnell ME, Solomon DH, Antman EM, Glynn RJ, Choudhry NK. Exploring patient experiences coping with using multiple medications: a qualitative interview study. BMJ Open 2021;11(11):e046860.Abstract
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.
Choudhry NK, Fontanet CP, Ghazinouri R, Fifer S, Archer KR, Haff N, Butterworth SW, Deogun H, Block S, Cooper A, Sears E, Goyal P, Coronado RA, Schneider BJ, Hsu E, Milstein A. 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. Contemp Clin Trials 2021;111:106602.Abstract
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 is being 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.