Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.

BACKGROUND: Results from the COORDINATE-Diabetes trial demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. METHODS: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. RESULTS: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). CONCLUSIONS: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT03936660.

Coordinating Cardiology clinics randomized trial of interventions to improve outcomes (COORDINATE) - Diabetes: rationale and design.

Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies.

Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial.

PURPOSE: Adults with a triple multimorbidity (hypertension, prediabetes or type 2 diabetes, and overweight or obesity), are at increased risk of serious health complications, but experts disagree on which dietary patterns and support strategies should be recommended. METHODS: We randomized 94 adults from southeast Michigan with this triple multimorbidity using a 2 × 2 diet-by-support factorial design, comparing a very low-carbohydrate (VLC) diet vs a Dietary Approaches to Stop Hypertension (DASH) diet, as well as comparing results with and without multicomponent extra support (mindful eating, positive emotion regulation, social support, and cooking). RESULTS: Using intention-to-treat analyses, compared with the DASH diet, the VLC diet led to greater improvement in estimated mean systolic blood pressure (-9.77 mm Hg vs -5.18 mm Hg; P = .046), greater improvement in glycated hemoglobin (-0.35% vs -0.14%; P = .034), and greater improvement in weight (-19.14 lb vs -10.34 lb; P = .0003). The addition of extra support did not have a statistically significant effect on outcomes. CONCLUSIONS: For adults with hypertension, prediabetes or type 2 diabetes, and overweight or obesity, the VLC diet resulted in greater improvements in systolic blood pressure, glycemic control, and weight over a 4-month period compared with the DASH diet. These findings suggest that larger trials with longer follow-up are warranted to determine whether the VLC diet might be more beneficial for disease management than the DASH diet for these high-risk adults.

Cooking behaviours after Diabetes Prevention Program (DPP) participation among DPP participants in Baltimore, MD.

OBJECTIVE: The Diabetes Prevention Program (DPP) is a widely implemented 12-month behavioural weight loss programme for individuals with prediabetes. The DPP covers nutrition but does not explicitly incorporate cooking skills education. The objective of the current study is to describe food and cooking skills (FACS) and strategies of recent DPP participants. DESIGN: Photo-elicitation in-depth interviews were conducted from June to August, 2021. SETTING: Baltimore, MD, USA. PARTICIPANTS: Thirteen Black women who participated in DPP. RESULTS: The DPP curriculum influenced participants' healthy cooking practices. Many participants reported shifting from frying foods to air-frying and baking foods to promote healthier cooking and more efficient meal preparation. Participants also reported that their participation in DPP made them more mindful of consuming fruits and vegetables and avoiding foods high in carbohydrates, fats, sugars and Na. With respect to food skills, participants reported that they were more attentive to reading labels and packaging on foods and assessing the quality of ingredients when grocery shopping. CONCLUSIONS: Overall, participants reported changing their food preferences, shopping practices and cooking strategies to promote healthier eating after completing the DPP. Incorporating hands-on cooking skills and practices into the DPP curriculum may support sustained behaviour change to manage prediabetes and prevent development of type 2 diabetes among participants.

Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Evidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice. Objective: To assess the effect of a coordinated, multifaceted intervention of assessment, education, and feedback vs usual care on the proportion of adults with type 2 diabetes and atherosclerotic cardiovascular disease prescribed all 3 groups of recommended, evidence-based therapies (high-intensity statins, angiotensin-converting enzyme inhibitors [ACEIs] or angiotensin receptor blockers [ARBs], and sodium-glucose cotransporter 2 [SGLT2] inhibitors and/or glucagon-like peptide 1 receptor agonists [GLP-1RAs]). Design, Setting, and Participants: Cluster randomized clinical trial with 43 US cardiology clinics recruiting participants from July 2019 through May 2022 and follow-up through December 2022. The participants were adults with type 2 diabetes and atherosclerotic cardiovascular disease not already taking all 3 groups of evidence-based therapies. Interventions: Assessing local barriers, developing care pathways, coordinating care, educating clinicians, reporting data back to the clinics, and providing tools for participants (n = 459) vs usual care per practice guidelines (n = 590). Main Outcomes and Measures: The primary outcome was the proportion of participants prescribed all 3 groups of recommended therapies at 6 to 12 months after enrollment. The secondary outcomes included changes in atherosclerotic cardiovascular disease risk factors and a composite outcome of all-cause death or hospitalization for myocardial infarction, stroke, decompensated heart failure, or urgent revascularization (the trial was not powered to show these differences). Results: Of 1049 participants enrolled (459 at 20 intervention clinics and 590 at 23 usual care clinics), the median age was 70 years and there were 338 women (32.2%), 173 Black participants (16.5%), and 90 Hispanic participants (8.6%). At the last follow-up visit (12 months for 97.3% of participants), those in the intervention group were more likely to be prescribed all 3 therapies (173/457 [37.9%]) vs the usual care group (85/588 [14.5%]), which is a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49 to 7.71]; P < .001) and were more likely to be prescribed each of the 3 therapies (change from baseline in high-intensity statins from 66.5% to 70.7% for intervention vs from 58.2% to 56.8% for usual care [adjusted OR, 1.73; 95% CI, 1.06-2.83]; ACEIs or ARBs: from 75.1% to 81.4% for intervention vs from 69.6% to 68.4% for usual care [adjusted OR, 1.82; 95% CI, 1.14-2.91]; SGLT2 inhibitors and/or GLP-1RAs: from 12.3% to 60.4% for intervention vs from 14.5% to 35.5% for usual care [adjusted OR, 3.11; 95% CI, 2.08-4.64]). The intervention was not associated with changes in atherosclerotic cardiovascular disease risk factors. The composite secondary outcome occurred in 23 of 457 participants (5%) in the intervention group vs 40 of 588 participants (6.8%) in the usual care group (adjusted hazard ratio, 0.79 [95% CI, 0.46 to 1.33]). Conclusions and Relevance: A coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease. Trial Registration: ClinicalTrials.gov Identifier: NCT03936660.

Incorporating SGLT2i and GLP-1RA for Cardiovascular and Kidney Disease Risk Reduction: Call for Action to the Cardiology Community.

Multiple sodium glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) have been shown to impart significant cardiovascular and kidney benefits, but are underused in clinical practice. Both SGLT-2i and GLP-1RA were first studied as glucose-lowering drugs, which may have impeded uptake by cardiologists in the wake of proven cardiovascular efficacy. Their significant effect on cardiovascular and kidney outcomes, which are largely independent of glucose-lowering effects, must drive a broader use of these drugs. Cardiologists are 3 times more likely than endocrinologists to see patients with both type 2 diabetes and cardiovascular disease, thus they are ideally positioned to share responsibility for SGLT-2i and GLP-1RA treatment with primary care providers. In order to increase adoption, SGLT-2i and GLP-1RA must be reframed as primarily cardiovascular and kidney disease risk-reducing agents with a side effect of glucose-lowering. Coordinated and multifaceted interventions engaging clinicians, patients, payers, professional societies, and health systems must be implemented to incentivize the adoption of these medications as part of routine cardiovascular and kidney care. Greater use of SGLT-2i and GLP-1RA will improve outcomes for patients with type 2 diabetes at high risk for cardiovascular and kidney disease.

Barriers to Guideline-Based Use of Proton Pump Inhibitors to Prevent Upper Gastrointestinal Bleeding.

PURPOSE: Gastrointestinal (GI) bleeding is one of the most common serious adverse drug events. Guidelines recommend proton pump inhibitor (PPI) gastroprotection to prevent upper GI bleeding in high-risk patients, but this practice is underused. METHODS: To explore prescribing practices and barriers to the use of PPI gastroprotection, including dynamics within and across specialties, we conducted semistructured interviews with physicians in 4 specialties at a single institution. We performed thematic analysis of barriers, organized around the theoretical domains framework. RESULTS: The sample included 5 primary care physicians (PCPs), 4 cardiologists, 3 gastroenterologists, and 3 vascular surgeons. Most PCPs, gastroenterologists, and vascular surgeons seldom prescribed PPI gastroprotection. Cardiologists varied most in their use of PPI gastroprotection, with some prescribing it consistently and others never. Major barriers related to the following 3 themes: (1) knowledge, (2) decision processes, and (3) professional role. Knowledge of guidelines was greatest among cardiologists and gastroenterologists and low among PCPs and vascular surgeons, and PCPs tended to focus on adverse effects associated with PPIs, which made them reluctant to prescribe them. For cardiologists, prevention of bleeding was usually a priority, but they sometimes deferred prescribing to others. For the other 3 specialties, PPI gastroprotection was a low priority. There was unclear delineation of responsibility for prescribing gastroprotection between specialties. CONCLUSIONS: Major barriers to PPI gastroprotection relate to knowledge, decision processes, and professional role, which operate differentially across specialties. Multicomponent interventions will likely be necessary to improve guideline-based use of PPIs to prevent upper GI bleeding.VISUAL ABSTRACT.

Impact of a Pilot Structured Mobile Technology Based Lifestyle Intervention for Patients with Nonalcoholic Fatty Liver Disease.

BACKGROUND AND AIMS: Lifestyle modification is the main treatment for nonalcoholic fatty liver disease (NAFLD), but remains challenging to implement. The aim of this pilot was to assess the acceptability and feasibility of a mobile-technology based lifestyle program for NAFLD patients. METHODS: We enrolled adult patients with NAFLD in a 6-month mobile-technology based program where participants received a FitBit with weekly tailored step count goals and nutritional assessments. Anthropometrics, hepatic and metabolic parameters, Fibroscan, physical function and activity, and health-related quality of life measures were obtained at enrollment and month 6. Semi-structured exit interviews were conducted to assess patient's experience with the program. RESULTS: 40 (63%) eligible patients were enrolled. Median age was 52.5 with 53% males, 93% whites, 43% with diabetes and median BMI 33.9. On baseline Fibroscan, 59% had F0-2 fibrosis and 70% had moderate-severe steatosis. 33 patients completed the study. Median percentage of days with valid FitBit data collection was 91. 4 patients increased and maintained, 19 maintained, and 8 increased but subsequently returned to baseline weekly step count. 59% of patients reported Fitbit was easy to use and 66% felt step count feedback motivated them to increase their activity. Roughly 50% of patients had reduction in weight, triglycerides and Fibroscan liver stiffness, and 75% had improvement in controlled attenuation parameter and physical function. CONCLUSIONS: A 6-month mobile-technology based pilot lifestyle intervention was feasible and acceptable to NAFLD patients. The program promoted physical activity and was associated with improvement in clinical parameters in some patients.

Continuous Glucose Monitoring With Low-Carbohydrate Nutritional Coaching to Improve Type 2 Diabetes Control: Randomized Quality Improvement Program.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control. OBJECTIVE: The aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC). METHODS: This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention. RESULTS: HbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use. CONCLUSIONS: Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.

Development and implementation of a community health centre-based cooking skills intervention in Detroit, MI.

OBJECTIVE: To develop and implement a community-tailored, food agency-based cooking programme at a community health centre (CHC) and evaluate the effect of the intervention on cooking confidence and food waste. DESIGN: This study used an exploratory, sequential mixed methods design. Focus groups (n 38) were conducted to inform the development of a cooking intervention, then six cooking classes (n 45) were planned and piloted in the health centre's teaching kitchen. Changes in cooking confidence and related outcomes were assessed using pre- and post-class surveys. Follow-up interviews (n 12) were conducted 2-4 months post-intervention to assess satisfaction and short-term outcomes. SETTING: A CHC in Detroit, MI. PARTICIPANTS: Spanish- and English-speaking adults aged ≥18 years recruited at the CHC. RESULTS: In the formative focus groups, patients identified multiple barriers to cooking healthy meals, including trade-offs between quality, cost and convenience of food, chronic disease management and lack of time and interest. Each cooking class introduced a variety of cooking techniques and food preservation strategies. Participants demonstrated increased confidence in cooking (P 0·004), experimenting with new ingredients (P 0·006) and knowing how to make use of food before it goes bad (P 0·017). In post-class interviews, participants reported that they valued the social interaction and participatory format and that they had used the recipes and cooking techniques at home. CONCLUSIONS: A community-tailored, hands-on cooking class was an effective way to engage patients at a CHC and resulted in increased cooking confidence.

Can Technology-Based Physical Activity Programs for Chronic Obstructive Pulmonary Disease Be Cost-Effective?

Objective: To evaluate the cost-effectiveness of a technology-based physical activity (PA) intervention for chronic obstructive pulmonary disease (COPD). Design: A secondary data analysis was performed from a randomized controlled trial in COPD of an activity monitor alone or an activity monitor plus a web-based PA intervention. Models estimated cost per quality-adjusted life year (QALY) and incremental cost-effectiveness ratios (ICERs) compared with usual care. Results: The estimated ICER for both groups was below the willingness-to-pay threshold of $50,000/QALY (activity monitor alone = $10,437/QALY; website plus activity monitor intervention = $13,065/QALY). A probabilistic simulation estimated 76% of the activity monitor-alone group and 78% of the intervention group simulations to be cost-effective. Conclusion(s): Both the activity monitor-alone group and the activity monitor plus website group were cost-effective at the base case by using conventional willingness-to-pay thresholds. Further research would benefit from a more direct estimate of health utilities and downstream health care costs. Clinical Trials.gov NCT01102777.

Physicians' Perceptions of Proton Pump Inhibitor Risks and Recommendations to Discontinue: A National Survey.

OBJECTIVE: To provide contemporary estimates of internists' perceptions of adverse effects associated with proton pump inhibitors (PPIs) and self-reported clinical use. METHODS: We invited 799 internists, including specialists and postgraduate trainees, to complete an online survey. Topics included perceptions of PPI adverse effects (AEs) and effectiveness for upper gastrointestinal bleeding (UGIB) prevention, changes in prescribing, and management recommendations for patients using PPIs for gastroesophageal reflux disease or UGIB prevention. We used logistic regression to identify factors associated with appropriate PPI continuation in the scenario of a patient at high risk for UGIB. RESULTS: Among 437 respondents (55% response rate), 10% were trainees and 72% specialized in general medicine, 70% were somewhat/very concerned about PPI AEs, and 76% had somewhat/very much changed their prescribing. A majority believed PPIs increase the risk for 6 of 12 AEs queried. Fifty-two percent perceived PPIs to be somewhat/very effective for UGIB prevention. In a gastroesophageal reflux disease scenario in which PPI can be safely discontinued, 86% appropriately recommended PPI discontinuation. However, in a high-risk UGIB prevention scenario in which long-term PPI use is recommended, 79% inappropriately recommended discontinuation. In this latter scenario, perceived effectiveness for bleeding prevention was strongly associated with continuing PPI (odds ratio 7.68, P < 0.001 for moderately; odds ratio 17.3, P < 0.001 for very effective). Other covariates, including concern about PPI AEs, had no significant association. DISCUSSION: Most internists believe PPIs cause multiple AEs and recommend discontinuation even in patients at high risk for UGIB. Future interventions should focus on ensuring that PPIs are prescribed appropriately according to individual risks and benefits.

Availability of Sexually Transmitted Infection Screening and Expedited Partner Therapy at Federally Qualified Health Centers in Michigan.

Via secret shopper study, we assessed: (1) availability of sexually transmitted infection (STI) screening; (2) provision of expedited partner therapy; and (3) wait times for new patient STI screening appointments at Michigan federally qualified health centers. Of the 147 clinics with STI screening availability, 10.2% (15) confirmed expedited partner therapy provision.

Insurance Coverage and Use of Hormones Among Transgender Respondents to a National Survey.

PURPOSE: We undertook a study to assess the associations between barriers to insurance coverage for gender-affirming hormones (either lack of insurance or claim denial) and patterns of hormone use among transgender adults. METHODS: We used data from the US Transgender Survey, a large national sample of 27,715 transgender adults, collected from August to September 2015. We calculated weighted proportions and performed multivariate logistic regression analyses. RESULTS: Of 12,037 transgender adults using hormones, 992 (9.17%) were using nonprescription hormones. Among insured respondents, 2,528 (20.81%) reported that their claims were denied. Use of nonprescription hormones was more common among respondents who were uninsured (odds ratio = 2.64; 95% CI, 1.88-3.71; P <.001) or whose claims were denied (odds ratio = 2.53; 95% CI, 1.61-3.97; P <.001). Uninsured respondents were also less likely to be using hormones (odds ratio = 0.37; 95% CI, 0.24-0.56; P <.001). CONCLUSIONS: Lack of insurance coverage for gender-affirming hormones is associated with lower overall odds of hormone use and higher odds of use of nonprescription hormones; such barriers may thus be linked to unmonitored and unsafe medication use, and increase the risks for adverse health outcomes. Ensuring access to hormones can decrease the economic burden transgender people face, and is an important part of harm-reduction strategies.

More frequent cooking at home is associated with higher Healthy Eating Index-2015 score.

OBJECTIVE: To examine the association between cooking frequency and Healthy Eating Index (HEI)-2015, overall and by income, among US adults. DESIGN: Cross-sectional analysis using multivariable linear regression models to examine the association between cooking frequency and total HEI-2015 score adjusted for sociodemographic variables, overall and stratified by income. SETTING: Nationally representative survey data from the USA. PARTICIPANTS: Adults aged ≥20 years (with 2 d of 24 h dietary recall data) obtained from the 2007 to 2010 National Health and Nutrition Examination Survey (n 8668). RESULTS: Compared with cooking dinner 0-2 times/week, greater cooking frequency was associated with higher HEI-2015 score overall (≥7 times/week: +3·57 points, P < 0·001), among lower-income adults (≥7 times/week: +2·55 points, P = 0·001) and among higher-income adults (≥7 times/week: +5·07 points, P < 0·001). Overall, total HEI-2015 score was higher among adults living in households where dinner was cooked ≥7 times/week (54·54 points) compared with adults living in households where dinner was cooked 0-2 times/week (50·57 points). In households in which dinner was cooked ≥7 times/week, total HEI-2015 score differed significantly based on income status (lower-income: 52·51 points; higher-income: 57·35 points; P = 0·003). Cooking frequency was associated with significant differences in HEI-2015 component scores, but associations varied by income. CONCLUSIONS: More frequent cooking at home is associated with better diet quality overall and among lower- and higher-income adults, although the association between cooking and better diet quality is stronger among high-income adults. Strategies are needed to help lower-income Americans consume a healthy diet regardless of how frequently they cook at home.

Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study.

BACKGROUND: Hypertension is a prevalent and costly burden in the United States. Clinical pharmacists within care teams provide effective management of hypertension, as does home blood pressure monitoring; however, concerns about data quality and latency are widespread. One approach to close the gap between clinical pharmacist intervention and home blood pressure monitoring is the use of mobile health (mHealth) technology. OBJECTIVE: We sought to investigate the feasibility, acceptability, and preliminary effectiveness of BPTrack, a clinical pharmacist-led intervention that incorporates patient- and clinician-facing apps to make electronically collected, patient-generated data available to providers in real time for hypertension management. The patient app also included customizable daily medication reminders and educational messages. Additionally, this study sought to understand barriers to adoption and areas for improvement identified by key stakeholders, so more widespread use of such interventions may be achieved. METHODS: We conducted a mixed methods pilot study of BPTrack, to improve blood pressure control in patients with uncontrolled hypertension through a 12-week pre-post intervention. All patients were recruited from a primary care setting where they worked with a clinical pharmacist for hypertension management. Participants completed a baseline visit, then spent 12 weeks utilizing BPTrack before returning to the clinic for follow-up. Collected data from patient participants included surveys pre- and postintervention, clinical measures (for establishing effectiveness, with the primary outcome being a change in blood pressure and the secondary outcome being a change in medication adherence), utilization of the BPTrack app, interviews at follow-up, and chart review. We also conducted interviews with key stakeholders. RESULTS: A total of 15 patient participants were included (13 remained through follow-up for an 86.7% retention rate) in a single group, pre-post assessment pilot study. Data supported the hypothesis that BPTrack was feasible and acceptable for use by patient and provider participants and was effective at reducing patient blood pressure. At the 12-week follow-up, patients exhibited significant reductions in both systolic blood pressure (baseline mean 137.3 mm Hg, SD 11.1 mm Hg; follow-up mean 131.0 mm Hg, SD 9.9 mm Hg; P=.02) and diastolic blood pressure (baseline mean 89.4 mm Hg, SD 7.7 mm Hg; follow-up mean 82.5 mm Hg, SD 8.2 mm Hg; P<.001). On average, patients uploaded at least one blood pressure measurement on 75% (SD 25%) of study days. No improvements in medication adherence were noted. Interview data revealed areas of improvement and refinement for the patient experience. Furthermore, stakeholders require integration into the electronic health record and a modified clinical workflow for BPTrack to be truly useful; however, both patients and stakeholders perceived benefits of BPTrack when used within the context of a clinical relationship. CONCLUSIONS: Results demonstrate that a pharmacist-led mHealth intervention promoting home blood pressure monitoring and clinical pharmacist management of hypertension can be effective at reducing blood pressure in primary care patients with uncontrolled hypertension. Our data also support the feasibility and acceptability of these types of interventions for patients and providers. TRIAL REGISTRATION: ClinicalTrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8059.

Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial.

BACKGROUND: Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE: The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS: Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS: The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P<.001) with no between-group differences at 6 months (P=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS: Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12526.

Patients' Perceptions of Proton Pump Inhibitor Risks and Attempts at Discontinuation: A National Survey.

OBJECTIVES: Little is known about how reports on the adverse effects of proton pump inhibitors (PPIs) impact patients' perceptions of these drugs and medication use. We sought to determine patients' level of concern about PPI adverse effects and its association with attempts to discontinue these drugs. METHODS: This study is an online survey of US adults who use PPIs for gastroesophageal reflux disease. Topics included awareness of and concern about PPI adverse effects, prior discussion with providers, and attempts to stop PPI because of concern about adverse effects. For the primary analysis, we used logistic regression to identify associations between having attempted to stop PPI and concern about PPI-related adverse effects, a provider's recommendation to stop, risk of upper gastrointestinal bleeding (UGIB), age, and gender. RESULTS: Among 755 patient participants, mean age was 49 years (s.d. 16), 71% were women, and 24% were at high risk of UGIB. Twenty percent of patients were able to write in ≥1 reported adverse effect, and 46% endorsed awareness of ≥1 adverse effect when presented with a list, most commonly chronic kidney disease (17%). Thirty-three percent of patients were slightly concerned, 32% somewhat concerned, and 14% extremely concerned about adverse effects. Twenty-four percent of patients had discussed PPI risks and benefits with a provider, and 9% had been recommended to stop. Thirty-nine percent had attempted to stop their PPI, most (83%) without a provider recommendation. Factors associated with an attempt at stopping PPI included: (i) provider recommendation to stop (odds ratio [OR] 3.26 [1.82-5.83]); (ii) concern about adverse effects (OR 5.13 [2.77-9.51] for slightly, 12.0 [6.51-22.2] for somewhat, and 19.4 [9.75-38.7] for extremely concerned); and (iii) female gender (OR 1.64 [1.12-2.39]). Patients at high risk of UGIB were as likely to have attempted to stop as others (OR 0.98 [0.66-1.44]). CONCLUSIONS: Concern about PPIs is common and strongly associated with attempts at discontinuation, even without a provider's recommendation. Notably, individuals at high risk of UGIB, who benefit from PPIs, were equally likely to have tried stopping PPIs as others. Providers should proactively discuss the risks and benefits of PPIs with their patients, who may otherwise make unwise decisions about PPI management on their own.

Variation in Physicians' Electronic Health Record Documentation and Potential Patient Harm from That Variation.

BACKGROUND: Physician-to-physician variation in electronic health record (EHR) documentation not driven by patients' clinical status could be harmful. OBJECTIVE: Measure variation in completion of common clinical documentation domains. Identify perceived causes and effects of variation and strategies to mitigate negative effects. DESIGN: Sequential, explanatory, mixed methods using log data from a commercial EHR vendor and semi-structured interviews with outpatient primary care practices. PARTICIPANTS: Quantitative: 170,332 encounters led by 809 physicians in 237 practices. Qualitative: 40 interviewees in 10 practices. MAIN MEASURES: Interquartile range (IQR) of the proportion of encounters in which a physician completed documentation, for each documentation category. Multilevel linear regression measured the proportion of variation at the physician level. KEY RESULTS: Five clinical documentation categories had substantial and statistically significant (p < 0.001) variation at the physician level after accounting for state, organization, and practice levels: (1) discussing results (IQR = 50.8%, proportion of variation explained by physician level = 78.1%); (2) assessment and diagnosis (IQR = 60.4%, physician-level variation = 76.0%); (3) problem list (IQR = 73.1%, physician-level variation = 70.1%); (4) review of systems (IQR = 62.3%, physician-level variation = 67.7%); and (5) social history (IQR = 53.3%, physician-level variation = 62.2%). Drivers of variation from interviews included user preferences and EHR designs with multiple places to record similar information. Variation was perceived to create documentation inefficiencies and risk patient harm due to missed or misinterpreted information. Mitigation strategies included targeted user training during EHR implementation and practice meetings focused on documentation standardization. CONCLUSIONS: Physician-to-physician variation in EHR documentation impedes effective and safe use of EHRs, but there are potential strategies to mitigate negative consequences.