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.

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.

Predicting hospitalizations from electronic health record data.

OBJECTIVES: Electronic health record (EHR) data have become increasingly available and may help inform clinical prediction. However, predicting hospitalizations among a diverse group of patients remains difficult. We sought to use EHR data to create and internally validate a predictive model for clinical use in predicting hospitalizations. STUDY DESIGN: Retrospective observational cohort study. METHODS: We analyzed EHR data in patients 18 years or older seen at Atrius Health from June 2013 to November 2015. We selected variables among patient demographics, clinical diagnoses, medications, and prior utilization to train a logistic regression model predicting any hospitalization within 6 months and validated the model using a separate validation set. We performed sensitivity analysis on model performance using combinations of EHR-derived, claims-derived, or both EHR- and claims-derived data. RESULTS: After exclusions, 363,855 patient-months were included for analysis, representing 185,388 unique patients. The strongest features included sickle cell anemia (odds ratio [OR], 52.72), lipidoses and glycogenosis (OR, 8.44), heart transplant (OR, 6.12), and age 76 years or older (OR, 5.32). Model testing showed that EHR-only data had an area under the receiver operating characteristic curve (AUC) of 0.84 (95% CI, 0.838-0.853), which was similar to the claims-only data (AUC, 0.84; 95% CI, 0.831-0.848) and combined claims and EHR data (AUC, 0.846; 95% CI, 0.838-0.853). CONCLUSIONS: Prediction models using EHR-only, claims-only, and combined data had similar predictive value and demonstrated strong discrimination for which patients will be hospitalized in the ensuing 6 months.

A Novel Information Retrieval Tool to Find Hospital Care Team Members: Development and Usability Study.

BACKGROUND: Hospital communication among members of a patient's care team is a central part of clinical workflow and consumes a large amount of a health care provider's time. Oftentimes the complexity of hospital care leads to difficulty in finding the appropriate contact, which can lead to inefficiencies and frustration. Squire is a Web-based information retrieval app created to improve the speed and efficiency in reaching the appropriate team member during the care of a hospitalized patient. OBJECTIVE: The objective of the study was to design and develop Squire and to evaluate the usage, usability, and perceived effect of the app on finding the correct contact within a hospital. METHODS: We used a mixed-methods design using a before-after survey methodology combined with one-on-one interviews to understand the perceived effect of Squire. The study took place at an academic medical center with internal medicine resident physicians. We surveyed residents on demographics, as well as time and efficiency of hospital communication before and after the use of Squire. After using Squire, participants were also asked to evaluate Squire's Net Promoter Score (NPS). A subset of voluntary participants participated in one-on-one interviews and completed the System Usability Scale (SUS). We performed descriptive statistics on participant characteristics, app usage data, and responses to surveys. Survey results were compared before and after Squire adoption using the Wilcoxon rank-sum test and a general linear model. Interview data were analyzed using content analysis with a qualitative description approach to review and categorize feedback from participants. RESULTS: There was a 67.9% (74/109) response rate to the pre-Squire survey and 89.9% (98/109) response rate to the post-Squire survey. At baseline, there was an average of 22.2 (95% CI 18.4-26.0) minutes/day spent searching for the right contact, and this decreased to 16.3 (95% CI 13.9-18.7) minutes/day after Squire was launched (P=.01). There were favorable usability scores, with an average SUS of 84.7, and a marginal NPS of +6.1. Overall, the use of Squire included 22,283 page views, most commonly to contact the admissions office or portable chest x-ray technician. Interviews highlighted common benefits of Squire, including decreased perceived time spent on hold with operators and improvement in connecting with the appropriate contact in specialized, complex departments. Future opportunities were also identified to improve Squire including adding a two-way communication between physician and nursing staff and providing offline access. CONCLUSIONS: Squire decreased the perceived time required to find an appropriate contact and had a favorable usability score; however, the NPS was marginal and several opportunities were identified to improve Squire for future use.

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.

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.

Implementation of a post-cardiac arrest care bundle including therapeutic hypothermia and hemodynamic optimization in comatose patients with return of spontaneous circulation after out-of-hospital cardiac arrest: a feasibility study.

Patients who present to the emergency department (ED) with return of spontaneous circulation after cardiac arrest generally have poor outcomes. Guidelines for treatment can be complicated and difficult to implement. This study examined the feasibility of implementing a care bundle including therapeutic hypothermia (TH) and early hemodynamic optimization for comatose patients with return of spontaneous circulation after out-of-hospital cardiac arrest. The study included patients over a 2-year period in the ED and intensive care unit of an academic tertiary-care medical center. The first year (prebundle) provided a historical control, followed by a prospective observational period of bundle implementation during the second year. The bundle elements included (a) TH initiated; (b) central venous pressure/central venous oxygen saturation monitoring in 2 h; (c) target temperature in 4 h; (d) central venous pressure greater than 12 mmHg in 6 h; (e) MAP greater than 65 mmHg in 6 h; (f) central venous oxygen saturation greater than 70% in 6 h; (g) TH maintained for 24 h; and (h) decreasing lactate in 24 h. Fifty-five patients were enrolled, 26 patients in the prebundle phase and 29 patients in the bundle phase. Seventy-seven percent of bundle elements were completed during the bundle phase. In-hospital mortality in bundle compared with prebundle patients was 55.2% vs. 69.2% (P = 0.29). In the bundle patients, those patients who received all elements of the care bundle had mortality 33.3% compared with 60.9% in those receiving some of the bundle elements (P = 0.22). Bundle patients tended to achieve good neurologic outcome compared with prebundle patients, Cerebral Performance Category 1 or 2 in 31 vs. 12% patients, respectively (P = 0.08). Our study demonstrated that a post-cardiac arrest care bundle that incorporates TH and early hemodynamic optimization can be implemented in the ED and intensive care unit collaboratively and can achieve similar clinical benefits compared with those observed in previous clinical trials.