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).

Telehealth Trends and Hypertension Management Among Rural and Medicaid Patients After COVID-19.

Objective: Examine the associations between rurality and low income with primary care telehealth utilization and hypertension outcomes across multiple years pre- and post-COVID-19 pandemic onset. Methods: We compiled electronic health record data from the mixed rural/urban Dartmouth Health system in New Hampshire, United States, on patients with pre-existing hypertension or diabetes receiving primary care in the period before (January 2018-February 2020) and after the transition period to telehealth during the COVID-19 Pandemic (October 2020-December 2022). Stratifying by rurality and Medicaid enrollment, we examined changes in synchronous (office and telehealth visits, including audio/video use) and asynchronous (patient portal or telephone message) utilization, and control of mean systolic blood pressure (SBP) <140. Results: Analysis included 46,520 patients, of whom 8.2% were Medicaid enrollees, 42.7% urban residents. Telehealth use rates were 12% for rural versus 6.4% for urban, and 15% for Medicaid versus 8.4% non-Medicaid. The overall postpandemic telehealth visit rate was 0.29 per patient per year. Rural patients had a larger increase in telehealth use (additional 0.21 per year, 95% CI, 0.19-0.23) compared with urban, as did Medicaid (0.32, 95% CI 0.29-0.36) compared with non-Medicaid. Among the 38,437 patients with hypertension, SBP control worsened from 83% to 79% of patients across periods. In multivariable analysis, rurality corresponded to worsened control rates compared with urban (additional 2.4% decrease, 95% CI 2.1-2.8%); Medicaid and telehealth use were not associated with worsened control. Conclusions: Telehealth expansion enabled a higher shift to telehealth for rural and low-income patients without impairing hypertension management.

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.

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

BACKGROUND: Individuals 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. OBJECTIVE: This 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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: The 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.

Comparison of a new 3-item self-reported measure of adherence to medication with pharmacy claims data in patients with cardiometabolic disease.

BACKGROUND: Less than half of patients with cardiometabolic disease consistently take prescribed medications. While health insurers and some delivery organizations use claims to measure adherence, most clinicians do not have access during routine interactions. Self-reported scales exist, but their practical utility is often limited by length or cost. By contrast, the accuracy of a new 3-item self-reported measure has been demonstrated in individuals with HIV. We evaluated its concordance with claims-based adherence measures in cardiometabolic disease. METHODS: We used data from a recently-completed pragmatic trial of patients with cardiometabolic conditions. After 12 months of follow-up, intervention subjects were mailed a survey with the 3-item measure that queries about medication use in the prior 30 days. Responses were linearly transformed and averaged. Adherence was also measured in claims in month 12 and months 1-12 of the trial using proportion of days covered (PDC) metrics. We compared validation metrics for non-adherence for self-report (average <0.80) compared with claims (PDC <0.80). RESULTS: Of 459 patients returning the survey (response rate: 43.5%), 50.1% were non-adherent in claims in month 12 while 20.9% were non-adherent based on the survey. Specificity of the 3-item metric for non-adherence was high (month 12: 0.83). Sensitivity was relatively poor (month 12: 0.25). Month 12 positive and negative predictive values were 0.59 and 0.52, respectively. CONCLUSIONS: A 3-item self-reported measure has high specificity but poor sensitivity for non-adherence versus claims in cardiometabolic disease. Despite this, the tool could help target those needing adherence support, particularly in the absence of claims data.

Exploring attitudes of adolescents and caregivers towards community-based delivery of the HPV vaccine: a qualitative study.

BACKGROUND: Human Papillomavirus (HPV) vaccination among adolescents is an important strategy to prevent cervical and other cancers in adulthood. However, uptake remains far below the Healthy People 2020 targets for the US. Given the barriers to population-level vaccination policies and challenges to incorporating additional action items during clinical visits, we sought to explore alternative delivery mechanisms, specifically delivery of the vaccine in community settings. METHODS: We conducted six focus groups (three with adolescents aged 11-14 who had not received the HPV vaccine and three with caregivers of adolescents meeting those criteria) from Black, Latino, and Brazilian communities in Massachusetts. We utilized a framework analysis approach that involved a multi-stage coding process employing both prefigured and emergent codes. Initial interpretations were refined through consultation with an advisory board. RESULTS: Adolescents and caregivers expressed a range of concerns about the HPV vaccine and also described interest in learning more about the vaccine, emphasizing the importance of a relationship with a trusted provider as a facilitator of vaccine acceptance. Regarding community-based delivery of the vaccine, reactions were mainly negative. However, adolescents and caregivers noted that receiving information in community settings that could seed a conversation with a trusted provider would be welcome. Interestingly, the notion of a trusted provider seemed to extend broadly to practitioners linked to the trusted main provider. CONCLUSIONS: The study highlights an opportunity for increasing HPV vaccination among some racial and ethnic minority populations by leveraging trusted community organizations to provide information and seed conversations with a potentially broad group of trusted providers. A task-shifting approach, or reliance on staff with fewer formal credentials, may offer opportunities to support vaccination in resource-constrained settings.

Association Between Recurrence and Re-Excision for Close and Positive Margins Versus Observation in Patients with Benign Phyllodes Tumors.

BACKGROUND: Breast lesions not sampled prior to surgery or initially diagnosed as fibroepithelial lesions on core biopsy may have a diagnosis of phyllodes tumor (PT) on excision. Historically, re-excision for close or positive margins has been the standard of care. We examined the rate of re-excision for close or positive margins in patients with benign phyllodes and compared recurrence rates among those undergoing re-excision versus observation. METHODS: We identified all patients with phyllodes tumor diagnosed between 2003 and 2013. Operative and surgical pathology reports were reviewed for clinical, pathologic, and follow-up data. RESULTS: Among 246 cases, 216 (88%) were benign PT and 30 (12%) borderline/malignant tumors. In the group of benign PT (n = 216), margins were negative in 64 patients (29.6%), 50 (23%) were close, and 102 (47%) were positive. Of those with close margins, 22 (44%) underwent reexcision and residual benign PT was found in 2 (9%). In patients with positive margins, 45 (44%) had re-excision and residual benign PT was detected in 4 (8.8%). After a median follow-up of 35.5 months, there were 4 (1.9%) recurrences among patients with benign PT. There was no difference in recurrence among patients who had re-excision for positive or close margins versus observation (p = 0.7 and 0.21, respectively). CONCLUSIONS: Among patients with close or positive margins, there was no significant difference in disease recurrence between patients who underwent reexcision and those who were observed. Based on these results, it may be reasonable to manage these patients conservatively with close follow-up.

Leveraging Habits to Improve Adherence to Gout Medications: A Qualitative Study.

OBJECTIVE: This study investigates patients' medication-taking routines and the feasibility of harnessing habit formation through context cues and rewards to improve medication adherence. METHODS: Semistructured qualitative interviews with patients with gout from an urban health care system were conducted to explore typical medication-taking behavior, experiences using electronic pill bottles, barriers to adherence, existing context cues, and potential cues and rewards for habit-forming behavior. Medication-taking patterns were recorded for six weeks using electronic pill bottles before interviews to inform discussion. Transcribed interviews were analyzed to generate themes using codes developed by the study team, with representative quotations selected as illustrations. RESULTS: We conducted interviews with 15 individuals (mean age 60.6 [SD 20.3] years, three women [20%], and nine White patients [60%]). Pill bottle-recorded adherence to urate-lowering therapy (ULT) was high (mean 0.91 [SD 0.10]), and one patient was experiencing an active gout flare. Five key themes emerged: (1) reasons for nonadherence, (2) internal and external motivations for adherence, (3) structured routines around taking medications, (4) rewards for good medication adherence, and (5) the role of pill cap technology in medication-taking. CONCLUSION: The importance of a predictable, structured routine in which participants could incorporate their medication-taking behavior emerged as a key factor that promoted consistent adherence. Further, identifying context cues and reminders seemed to promote incorporation of medication-taking into routines. Therefore, habit-based interventions that use context cues to establish routines around medication-taking may be a feasible strategy to improve adherence in patients with chronic conditions such as gout.

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.

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.

Comparison of measures of medication adherence from pharmacy dispensing and insurer claims data.

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.

Out-of-Pocket Expenditures for Delivery for Maternity Waiting Home Users and Non-users in Rural Zambia.

BACKGROUND: Utilizing maternity waiting homes (MWHs) is a strategy to improve access to skilled obstetric care in rural Zambia. However, out-of-pocket (OOP) expenses remain a barrier for many women. We assessed delivery-related expenditure for women who used MWHs and those who did not who delivered at a rural health facility. METHODS: During the endline of an impact evaluation for an MWH intervention, household surveys (n = 826) were conducted with women who delivered a baby in the previous 13 months at a rural health facility and lived >10 km from a health facility in seven districts of rural Zambia. We captured the amount women reported spending on delivery. We compared OOP spending between women who used MWHs and those who did not. Amounts were converted from Zambian kwacha (ZMW) to US dollar (USD). RESULTS: After controlling for confounders, there was no significant difference in delivery-related expenditure between women who used MWHs (US$40.01) and those who did not (US$36.66) (P=.06). Both groups reported baby clothes as the largest expenditure. MWH users reported spending slightly more on accommodation compared to those did not use MWHs, but this difference represents only a fraction of total costs associated with delivery. CONCLUSION: Findings suggest that for women coming from far away, utilizing MWHs while awaiting delivery is not costlier overall than for women who deliver at a health facility but do not utilize a MWH.

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.

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).

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.

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).

A Qualitative Exploration of Community Ownership of a Maternity Waiting Home Model in Rural Zambia.

CONTEXT: Ownership is an important construct of sustainability for community-based health programming, though it is often not clearly defined or measured. We implemented and evaluated a community-driven maternity waiting home (MWH) model in rural Zambia. We engaged stakeholders at all levels and provided intensive mentorship to an MWH governance committee comprised of community-selected members. We then examined how different stakeholders perceive community ownership of the MWH. METHODS: We conducted 42 focus group discussions with community stakeholders (pregnant women, fathers, elders, and community health volunteers) and 161 in-depth interviews with MWH stakeholders (health facility staff, district health officials, and MWH governance committee and management unit members) at multiple time-points over 24 months. We conducted a content analysis and triangulated findings to understand community ownership of the MWH and observe changes in perceptions of ownership over time. RESULTS: Community members' perceptions of ownership were related to their ability to use the MWH and a responsibility toward its success. Community and MWH stakeholders described increasingly more specific responsibilities over time. Governance committee and management unit members perceived their ability to represent the community as a crucial component of their role. Multiple respondent types saw collaboration between the governance committee and the health facility staff as key to allowing the MWH to meet its goal of serving the community. CONCLUSION: The perceptions of community ownership evolved as the intervention became more established. Use of the MWH, and clear understanding of roles and responsibilities in management of the MWH, seemed to foster feelings of community ownership. To improve the sustainability of community-based maternal and child health programs, interventions should be accessible to target communities and clear roles should be established among stakeholders.

Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic randomized trial.

BACKGROUND: Many factors contribute to suboptimal diabetes control including insufficiently-intensive treatment and non-adherence to medication and lifestyle. Determining which of these is most relevant for individual patients is challenging. Patient engagement techniques may help identify contributors to suboptimal adherence and address barriers (using motivational interviewing) and help facilitate choices among treatment augmentation options (using shared decision-making). These methods have not been used in combination to improve diabetes outcomes. OBJECTIVE: To evaluate the impact of a telephone-based patient-centered intervention on glycosylated hemoglobin (HbA1c) control for individuals with poorly-controlled diabetes. DESIGN: Two-arm pragmatic randomized control trial within an explanatory sequential mixed-methods design. SUBJECTS: 1,400 participants 18-64 years old with poorly-controlled type 2 diabetes. INTERVENTION: The intervention was delivered over the telephone by a clinical pharmacist and consisted of a 2-step process that integrated brief negotiated interviewing and shared decision-making to identify patient goals and options for enhancing diabetes management. MAIN MEASURES: The primary outcome was change in HbA1c. Secondary outcomes were medication adherence measures. Outcomes were evaluated using intention-to-treat principles; multiple imputation was used for missing values in the 12-month follow-up. We used information from pharmacist notes to elicit factors to potentially explain the intervention's effectiveness. KEY RESULTS: Participants had a mean age of 54.7 years (SD:8.3) and baseline HbA1c of 9.4 (SD:1.6). Change in HbA1c from baseline was -0.79 (SD:2.01) in the control arm and -0.75 (SD:1.76) in the intervention arm (difference:+0.04, 95%CI: -0.22, 0.30). There were no significant differences in adherence. In as-treated analyses, the intervention significantly improved diabetes control (-0.48, 95%CI: -0.91, -0.05). Qualitative findings provided several potential explanations for the findings, including insufficiently addressing patient barriers. CONCLUSIONS: A novel telephone-based patient-centered intervention did not improve HbA1c among individuals with poorly-controlled diabetes, though as-treated analyses suggest that the intervention was effective for those who received it. TRIAL REGISTRATION: ClinicalTrials.gov NCT02910089.