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.

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.

Short-Term Surgical Missions: Role of Pharmacist Volunteers.

Health care professionals often participate in short-term surgical missions in underserved areas of the world. Surgical missions often rely on the use of medications to provide health care to these underserved areas in patients with multiple comorbid conditions. The direct role a pharmacist may have in surgical missions is not well described in the literature; however, numerous opportunities exist for pharmacist involvement to improve patient care and operational processes throughout medication planning and delivery of surgical missions. Pharmacists have specialized knowledge in medication acquisition, preparation, and distribution that result in a unique position to contribute positively to the mission's clinical and operational dynamics. Pharmacists may assist in various activities such as medication ordering, accrual, purchasing and preparing during the surgical mission. Pharmacists may also provide clinical support and offer alternative medications in the setting of drug intolerance or allergies. In 2008, Operation Walk Boston, a short-term surgical mission was established to provide hip and knee joint replacements to patients in the Dominican Republic. Pharmacists and pharmacy residents play a crucial role as members of this surgical mission. Based on our experience, this article aims to describe the evolving role of pharmacists as a member of a surgical mission.

Association of Potentially Modifiable Diabetes Care Factors With Glycemic Control in Patients With Insulin-Treated Type 2 Diabetes.

Importance: Numerous factors are associated with the ability of patients with type 2 diabetes to achieve optimal glycemic control. However, many of these factors are not modifiable by quality improvement interventions. In contrast, the structure of how diabetes care is delivered, such as whether patients visit an endocrinologist or how prescriptions are filled, is potentially modifiable, yet its associations with glycemic control have not been rigorously evaluated. Objective: To investigate the association of diabetes care delivery with glycemic control in patients with type 2 diabetes using insulin. Design, Setting, and Participants: This retrospective cohort study used baseline claims and laboratory insurer data within a large pragmatic trial to identify individuals with type 2 diabetes using insulin with data for at least 1 hemoglobin A1c (HbA1c) test result from before trial randomization (July 1, 2014, to October 5, 2016) and for key nonmodifiable patient factors as well as diabetes care delivery and behavioral factors measured before the HbA1c test. Analyses were conducted from February 4, 2017, to November 13, 2018. Main Outcomes and Measures: Multivariable modified Poisson regression was used to evaluate the independent associations of nonmodifiable patient factors and potentially modifiable diabetes care delivery and patient behavioral factors with achieving adequate diabetes control (ie, HbA1c level <8%). The extent of measured variation explained in glycemic control by these factors was also explored using pseudo R2 and C statistics. Results: Of 1423 patients included, 565 (39.7%) were women, and the mean (SD) age was 56.4 (9.0) years. In total, 690 (48.5%) had HbA1c levels less than 8%. Age (relative risk [RR] per 1-unit increase, 1.01; 95% CI, 1.00-1.02), persistent use of basal insulin (RR, 1.20; 95% CI, 1.00-1.43), more frequent filling of glucose self-testing supplies (RR, 1.01; 95% CI, 1.01-1.02), visiting an endocrinologist (RR, 1.41; 95% CI, 1.19-1.67), and receipt of insulin prescriptions by mail order (RR, 1.23; 95% CI, 1.03-1.48) were all independently associated with adequate control. Measured potentially modifiable diabetes care factors explained more variation in adequate glycemic control than measured nonmodifiable patient factors (C statistic, 0.661 vs 0.598; pseudo R2 = 0.11 vs 0.04). Conclusions and Relevance: These findings suggest that for patients with type 2 diabetes using insulin, the way in which care is delivered may be more strongly associated with achieving adequate control of HbA1c levels than patient factors that cannot be altered are. Given the potential for intervention, these care delivery factors could be the focus of efforts to improve diabetes outcomes.

Development of Patient Education Materials for Total Joint Replacement During an International Surgical Brigade.

BACKGROUND: Temporary brigade trips to deliver international surgical care are increasingly common. For the purposes of this work, we use the term brigade to describe self-contained short-term medical or surgical mission trips where healthcare professionals are brought in from foreign regions to provide care to an underserved population. Many brigade programs have begun to collect and publish data on outcomes and complications, but few have examined their own patient education practices. METHODS: We used evidence-based readability and suitability analyses along with patient interviews to develop improved patient education materials for a total joint replacement surgical brigade in the Dominican Republic. RESULTS: Existing patient education materials required an eighth grade reading level and lacked suitability based on the principles of educational theory. The redesigned materials required fifth grade reading skills or less and had superior suitability. Pilot testing with patients from the target population suggested that the materials were appealing and appropriate. CONCLUSIONS: Patient education may play an important role in optimizing outcomes in the setting of medical or surgical brigades where resources and access to follow-up care are limited. More research is needed to bring attention to the importance of patient education during brigades, and programs should work with patients to develop educational materials that are suitable and effective.

The accuracy of self-reported blood pressure in the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial: Implications for pragmatic trials.

Self-report of health conditions and behaviors is one potential strategy to increase the pace of enrollment into pragmatic clinical trials. In this study, we assessed the accuracy of self-reported poorly controlled hypertension among adults in the community who were screened for participation in the MedISAFE-BP trial. Of individuals who self-reported poorly controlled hypertension using the online trial enrollment platform, 64% had a systolic blood pressure less than 140 mm Hg when measured at home. Although we identified several characteristics associated with accurate self-report including older age (odds ratio [OR] 1.02 per year, 95% CI 1.01-1.03), diabetes (OR 1.59, 95% CI 1.17-2.14), and low health activation (OR 1.56 95% CI 1.17-2.07), we were unable to identify patients for whom self-reported hypertension would be a reliable method for their inclusion in a pragmatic trial.

The uptake of family screening in hypertrophic cardiomyopathy and an online video intervention to facilitate family communication.

BACKGROUND: Individuals with hypertrophic cardiomyopathy (HCM), even when asymptomatic, are at-risk for sudden cardiac death and stroke from arrhythmias, making it imperative to identify individuals affected by this familial disorder. Consensus guidelines recommend that first-degree relatives (FDRs) of a person with HCM undergo serial cardiovascular evaluations. METHODS: We determined the uptake of family screening in patients with HCM and developed an online video intervention to facilitate family communication and screening. Family screening and genetic testing data were collected through a prospective quality improvement initiative, a standardized clinical assessment and management plan (SCAMP), utilized in an established cardiovascular genetics clinic. Patients were prescribed an online video if screening of their FDRs was incomplete and a pilot study on video utilization and family communication was conducted. RESULTS: Two-hundred and sixteen probands with HCM were enrolled in SCAMP Phase I and 190 were enrolled in SCAMP Phase II. In both phases, probands reported that 51% of FDRs had been screened (382/749 in Phase I, 258/504 in Phase II). Twenty patients participated in a pilot study on video utilization and family communication. Nine participants reported watching the video and six participants reported sharing the video with relatives; however only one participant reported sharing the video with relatives who were not yet aware of the diagnosis of HCM in the family. CONCLUSION: Despite care in a specialized cardiovascular genetics clinic, approximately one half of FDRs of patients with HCM remained unscreened. Online interventions and videos may serve as supplemental tools for patients communicating genetic risk information to relatives.

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.

Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Patient adherence to antidiabetic medications, especially insulin, remains poor, leading to adverse outcomes and increased costs. Most adherence interventions have only been modestly effective, partly because they are not targeted to patients who could benefit most. Objective: To evaluate whether delivering more intensive insulin-adherence interventions only to individuals with type 2 diabetes predicted to benefit most was more effective than delivering a lower-intensity intervention to a larger group of unselected individuals. Design, Setting, and Participants: This 3-arm pragmatic randomized clinical trial used data from Horizon, the largest health insurer in New Jersey, on 6000 participants 18 years or older with type 2 diabetes who were receiving basal insulin. Patients were excluded if they were insured by Medicaid or Medicare or had fewer than 3 months of continuous enrollment. The study was conducted from July 7, 2016, through October 5, 2017. Analyses were conducted from February 5 to September 24, 2018. Interventions: Eligible patients were randomized to 3 arms in a 1:1:1 ratio. Randomization was stratified based on baseline availability of 1 or more glycated hemoglobin A1c (HbA1c) test values. All arms were designed to cost the same, and each cohort received a tailored pharmacist telephone consultation varying based on (1) proportion receiving the intervention and (2) intensity, including follow-up frequency and cointerventions. Arm 1 offered a low-intensity intervention to all patients. Arm 2 offered a moderate-intensity intervention to 60% of patients based on their predicted risk of insulin nonadherence. Arm 3 offered a high-intensity intervention to 40% of patients based on glycemic control and predicted risk of insulin nonadherence. Main Outcomes and Measures: The primary outcome was insulin persistence. Secondary outcomes were changes in HbA1c level and health care utilization. Outcomes were evaluated in arms 2 and 3 vs arm 1 using claims data, intention-to-treat principles, and multiple imputation for missing values in the 12-month follow-up. Results: Among 6000 participants, mean (SD) age was 55.9 (11.0) years and 3344 (59.8%) were male. Compared with arm 1, insulin nonpersistence did not differ in arm 2 (relative risk, 0.88; 95% CI, 0.75-1.03) or arm 3 (relative risk, 0.91; 95% CI, 0.77-1.06). Glycemic control was similar in arm 2 and arm 1 (absolute HbA1c level difference, -0.15%; 95% CI, -0.34% to 0.05%) but was better in arm 3 (absolute HbA1c level difference, -0.25%; 95% CI, -0.43% to -0.06%). Total spending and office visits did not differ, but arm 2 (moderate intensity intervention) had more hospitalizations (odds ratio, 1.22; 95% CI, 1.06-1.41) and emergency department visits (odds ratio, 1.38; 95% CI, 1.24-1.53) than did arm 1 (low intensity intervention). Conclusions and Relevance: Compared with an untargeted low-intensity intervention, delivering a highly targeted high-intensity intervention did not improve insulin persistence but modestly improved mean glycemic control. A partially targeted moderate-intensity intervention did not change insulin persistence or HbA1c level but was associated with a small increase in hospitalizations. Trial Registration: ClinicalTrials.gov Identifier: NCT02846779.

Reasons for Guideline Nonadherence at Heart Failure Discharge.

Background Cardiology has advanced guideline development and quality measurement. Recognizing the substantial benefits of guideline-directed medical therapy, this study aims to measure and explain apparent deviations in heart failure ( HF ) guideline adherence by clinicians at hospital discharge and describe any impact on readmission rates. Methods and Results The extent of decongestion and prescription of neurohormonal therapy were recorded prospectively for 226 HF discharges, including 132 (58%) from an academic hospital and 94 (42%) from a community hospital. Among all discharges, 25% were discharged with residual congestion (30% academic versus 18% community, P=0.070). Among discharges of patients with HF with reduced ejection fraction, 37% (45% academic versus 18% community, P<0.001) were discharged without ß-blocker therapy or with lower doses than at admission. Moreover, 46% of patients with HF with reduced ejection fraction (48% academic versus 39% community, P=0.390) were discharged without an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker or with lower doses than at admission. Renal dysfunction was the most common reason for discharge with congestion, and hypotension the most common reason for discharge with no or decreased neurohormonal therapy. There was a trend toward higher 90-day readmission rates after discharge with residual congestion. Conclusions Clinicians frequently deviate from guidelines in both academic and community hospitals; however, this deviation may not always indicate poor quality. Application of guidelines recommended for stable populations is increasingly limited for hospitalized patients by hypotension, renal dysfunction, and inotrope use. Patients with renal dysfunction, hypotension, and recent inotrope use merit further study to determine best practices and possibly to adjust quality metrics for HF severity.

Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial.

Importance: Medication nonadherence accounts for up to half of uncontrolled hypertension. Smartphone applications (apps) that aim to improve adherence are widely available but have not been rigorously evaluated. Objective: To determine if the Medisafe smartphone app improves self-reported medication adherence and blood pressure control. Design, Setting, and Participants: This was a 2-arm, randomized clinical trial (Medication Adherence Improvement Support App For Engagement-Blood Pressure [MedISAFE-BP]). Participants were recruited through an online platform and were mailed a home blood pressure cuff to confirm eligibility and to provide follow-up measurements. Of 5577 participants who were screened, 412 completed consent, met inclusion criteria (confirmed uncontrolled hypertension, taking 1 to 3 antihypertensive medications), and were randomized in a ratio of 1:1 to intervention or control. Interventions: Intervention arm participants were instructed to download and use the Medisafe app, which includes reminder alerts, adherence reports, and optional peer support. Main Outcomes and Measures: Co-primary outcomes were change from baseline to 12 weeks in self-reported medication adherence, measured by the Morisky medication adherence scale (MMAS) (range, 0-8, with lower scores indicating lower adherence), and change in systolic blood pressure. Results: Participants (n = 411; 209 in the intervention group and 202 controls) had a mean age of 52.0 years and mean body mass index, calculated as weight in kilograms divided by height in meters squared, of 35.5; 247 (60%) were female, and 103 (25%) were black. After 12 weeks, the mean (SD) score on the MMAS improved by 0.4 (1.5) among intervention participants and remained unchanged among controls (between-group difference: 0.4; 95% CI, 0.1-0.7; P = .01). The mean (SD) systolic blood pressure at baseline was 151.4 (9.0) mm Hg and 151.3 (9.4) mm Hg, among intervention and control participants, respectively. After 12 weeks, the mean (SD) systolic blood pressure decreased by 10.6 (16.0) mm Hg among intervention participants and 10.1 (15.4) mm Hg among controls (between-group difference: -0.5; 95% CI, -3.7 to 2.7; P = .78). Conclusions and Relevance: Among individuals with poorly controlled hypertension, patients randomized to use a smartphone app had a small improvement in self-reported medication adherence but no change in systolic blood pressure compared with controls. Trial Registration: clinicaltrials.gov Identifier: NCT02727543.

A Conceptual Model for the Evaluation of Surgical Missions.

BACKGROUND: Medical missions to low and middle-income countries are increasingly frequent, with an estimated 6,000 trips sponsored by U.S. organizations accounting for approximately 200,000 surgical cases and $250 million in costs annually. However, these missions have received little critical evaluation. This paper describes the research program Operation Walk (Op-Walk) Boston, and proposes an evaluation model for similar surgical missions. METHODS: We propose an evaluation model, borrowing from the work of Donabedian and enriched by evidence from our research program. The model calls for evaluation of the salient contextual factors (culture and beliefs), system management (structure, process, and outcomes), and sustainability of the program's interventions. We used these domains to present findings from the quantitative and qualitative research work of Op-Walk Boston. RESULTS: Op-Walk's qualitative research findings demonstrated that cultural factors are important determinants of patients' perceptions of arthritis etiology, physical activity patterns, and treatment preferences. Quantitative assessments documented that Dominican patients had worse lower-extremity functional status (mean Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function score of 33.6) and pain preoperatively than patients undergoing total hip or knee replacement in the U.S. (WOMAC function score of 43.3 to 54), yet they achieved excellent outcomes (50-point improvement), comparable to those of their U.S. counterparts. Assessments of the quality and sustainability of the Op-Walk program showed that the quality of care provided by Op-Walk Boston meets Blue Cross Blue Shield Centers of Excellence (Blue Distinction) criteria, and that sustainable changes were transferred to the host hospital. CONCLUSIONS: Our proposed model offers a method for formal assessment of medical missions that addresses the call for evidence of their merit. We suggest that surgical missions adopt quantitative and qualitative strategies to document their impact, identify areas of improvement, and justify program continuation, growth, and support.

Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries.

The influenza ('flu') vaccination is low cost1 and effective, typically reducing the likelihood of infection by 50-60%2. It is recommended for nearly everyone older than 6 months of age3; yet, only 40% of Americans are immunized each year. Vaccination rates are higher among at-risk groups, such as those ≥65 years of age, but still only 6 in 10 receive it4. There have been numerous attempts to improve vaccination rates using strategies such as school-based programmes, financial incentives and reminders, but these have generally had limited success5-7. Of the attempts that are successful, most are expensive-limiting scalability-and have not been evaluated in the elderly8. Conversely, lower-cost interventions, such as mailed information, hold promise for a scalable solution, but their limited effectiveness may result from how they have been designed. We randomly assigned 228,000 individuals ≥66 years of age to one of five versions of letters intended to motivate vaccination, including versions with an implementation intention prompt and an enhanced active choice implementation prompt. We found that a single mailed letter significantly increased influenza vaccination rates compared with no letter. However, there was no difference in vaccination rates across the four different letters tailored with behavioural science techniques.

Rationale and design of the ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic trial.

BACKGROUND: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making). OBJECTIVE: To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes. METHODS/DESIGN: ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data. CONCLUSIONS: This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes.

Rationale and design of the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial.

BACKGROUND: Hypertension is a major contributor to the health and economic burden imposed by stroke, heart disease, and renal insufficiency. Antihypertensives can prevent many of the harmful effects of elevated blood pressure, but medication nonadherence is a known barrier to the effectiveness of these treatments. Smartphone-based applications that remind patients to take their medications, provide education, and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing. METHODS/DESIGN: The MedISAFE-BP study is a prospective, randomized control trial designed to evaluate the impact on blood pressure and medication adherence of an mhealth application (Medisafe). Four hundred thirteen patients with uncontrolled hypertension have been enrolled and randomized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform. Patients will be followed up for 12 weeks and the trial's co-primary outcomes will be change in systolic blood pressure and self-reported medication adherence. DISCUSSION: The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application's effect on blood pressure and medication adherence. The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes.

A Decision-Making Algorithm for Initiation and Discontinuation of RRT in Severe AKI.

BACKGROUND AND OBJECTIVES: AKI is an increasingly common and devastating complication in hospitalized patients. Severe AKI requiring RRT is associated with in-hospital mortality rates exceeding 40%. Clinical decision making related to RRT initiation for patients with AKI in the medical intensive care unit is not standardized. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a 13-month (November of 2013 to December of 2014) prospective cohort study in an academic medical intensive care unit involving the implementation of an AKI Standardized Clinical Assessment and Management Plan, a decision-making algorithm to assist front-line clinicians caring for patients with AKI. The Standardized Clinical Assessment and Management Plan algorithms provided recommendations about optimal indications for initiating and discontinuing RRT on the basis of various clinical parameters; 176 patients managed by nine nephrologists were included in the study. We captured reasons for deviation from the recommended algorithm as well as mortality data. RESULTS: Patients whose clinicians adhered to the Standardized Clinical Assessment and Management Plan recommendation to start RRT had lower in-hospital mortality (42% versus 63%; P<0.01) and 60-day mortality (46% and 68%; P<0.01), findings that were confirmed after multivariable adjustment for age, albumin, and disease severity. There was a differential effect of Standardized Clinical Assessment and Management Plan adherence in low (<50% mortality risk) versus high (≥50% mortality risk) disease severity on in-hospital mortality (interaction term P=0.02). In patients with low disease severity, Standardized Clinical Assessment and Management Plan adherence was associated with lower in-hospital mortality (odds ratio, 0.21; 95% confidence interval, 0.08 to 0.54; P=0.001), but no significant association was evident in patients with high disease severity. CONCLUSIONS: Physician adherence to an algorithm providing recommendations on RRT initiation was associated with lower in-hospital mortality.

Implementation of a Risk Stratification and Management Pathway for Acute Chest Pain in the Emergency Department.

OBJECTIVES: Chest pain is a common complaint in the emergency department, and a small but important minority represents an acute coronary syndrome (ACS). Variation in diagnostic workup, risk stratification, and management may result in underuse, misuse, and/or overuse of resources. METHODS: From July to October 2014, we conducted a prospective cohort study in an academic medical center by implementing a Standardized Clinical Assessment and Management Plan (SCAMP) for chest pain based on the HEART score. In addition to capturing adherence to the SCAMP algorithm and reasons for any deviations, we measured troponin sample timing; rates of stress test utilization; length of stay (LOS); and 30-day rates of revascularization, ACS, and death. RESULTS: We identified 239 patients during the enrollment period who were eligible to enter the SCAMP, of whom 97 patients were entered into the pathway. Patients were risk stratified into one of 3 risk tiers: high (n = 3), intermediate (n = 40), and low (n = 54). Among low-risk patients, recommendations for troponin testing were not followed in 56%, and 11% received stress tests contrary to the SCAMP recommendation. None of the low-risk patients had elevated troponin measurements, and none had an abnormal stress test. Mean LOS in low-risk patients managed with discordant plans was 22:26 h/min, compared with 9:13 h/min in concordant patients (P < 0.001). Mean LOS in intermediate-risk patients with stress testing was 25:53 h/min, compared with 7:55 h/min for those without (P < 0.001). At 30 days, 10% of intermediate-risk patients and 0% of low-risk patients experienced an ACS event (risk difference 10% [0.7%-19%]); none experienced revascularization or death. The most frequently cited reason for deviation from the SCAMP was lack of confidence in the tool. CONCLUSIONS: Compliance with SCAMP recommendations for low- and intermediate-risk patients was poor, largely due to lack of confidence in the tool. However, in our study population, outcomes suggest that deviation from the SCAMP yielded no additional clinical benefit while significantly prolonging emergency department LOS.

Postoperative Pain Management Among Dominican and American Health-Care Providers: A Qualitative Analysis.

BACKGROUND: U.S. practitioners have prescribed opioid analgesics increasingly in recent years, contributing to what has been declared an opioid epidemic by the U.S. Centers for Disease Control and Prevention (CDC). Opioids are used frequently in the preoperative and postoperative periods for patients undergoing total joint replacement in developed countries, but cross-cultural comparisons of this practice are limited. An international medical mission such as Operation Walk Boston, which provides total joint replacement to financially vulnerable patients in the Dominican Republic, offers a unique opportunity to compare postoperative pain management approaches in a developed nation and a developing nation. METHODS: We interviewed American and Dominican surgeons and nurses (n = 22) during Operation Walk Boston 2015. We used a moderator's guide with open-ended questions to inquire about postoperative pain management and factors influencing prescribing practices. Interviews were recorded and transcripts were analyzed using content analysis. RESULTS: Providers highlighted differences in the patient-provider relationship, pain medication prescribing variability, and access to medications. Dominican surgeons emphasized adherence to standardized pain protocols and employed a paternalistic model of care, and American surgeons reported prescribing variability and described shared decision-making with patients. Dominican providers described limited availability of potent opioid preparations in the Dominican Republic, in contrast to American providers, who discussed opioid accessibility in the United States. CONCLUSIONS: Our findings suggest that cross-cultural comparisons provide insight into how opioid prescribing practices, approaches to the patient-provider relationship, and medication access inform distinct pain management strategies in American and Dominican surgical settings. Integrating lessons from cross-cultural pain management studies may yield more effective pain management strategies for surgical procedures performed in the United States and abroad.

Development of Standardized Clinical Assessment and Management Plans (SCAMPs) in Plastic and Reconstructive Surgery.

BACKGROUND: With rising cost of healthcare, there is an urgent need for developing effective and economical streamlined care. In clinical situations with limited data or conflicting evidence-based data, there is significant institutional and individual practice variation. Quality improvement with the use of Standardized Clinical Assessment and Management Plans (SCAMPs) might be beneficial in such scenarios. The SCAMPs method has never before been reported to be utilized in plastic surgery. METHODS: The topic of immediate breast reconstruction was identified as a possible SCAMPs project. The initial stages of SCAMPs development, including planning and implementation, were entered. The SCAMP Champion, along with the SCAMPs support team, developed targeted data statements. The SCAMP was then written and a decision-tree algorithm was built. Buy-in was obtained from the Division of Plastic Surgery and a SCAMPs data form was generated to collect data. RESULTS: Decisions pertaining to "immediate implant-based breast reconstruction" were approved as an acceptable topic for SCAMPs development. Nine targeted data statements were made based on the clinical decision points within the SCAMP. The SCAMP algorithm, and the SDF, required multiple revisions. Ultimately, the SCAMP was effectively implemented with multiple iterations in data collection. CONCLUSIONS: Full execution of the SCAMP may allow better-defined selection criteria for this complex patient population. Deviations from the SCAMP may allow for improvement of the SCAMP and facilitate consensus within the Division. Iterative and adaptive quality improvement utilizing SCAMPs creates an opportunity to reduce cost by improving knowledge about best practice.