Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease: A Cluster Randomized Clinical Trial.

Importance: Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes. Objective: To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs). Design, Setting, and Participants: This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention. Interventions: A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations. Main Outcomes and Measures: One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control). Results: Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P < .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001). Conclusions and Relevance: The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk. Trial Registration: ClinicalTrials.gov Identifier: NCT03001713.

Implementing a prediabetes clinical decision support system in a large primary care system: Design, methods, and pre-implementation results.

BACKGROUND: Early detection of prediabetes and management of cardiovascular (CV) risk factors to prevent CV disease is essential, but clinicians are often slow to address this risk. Clinical decision support (CDS) systems, with appropriate implementation, can potentially improve prediabetes identification and treatment. METHODS/DESIGN: 34 Midwestern primary care clinics were randomized to receive or not receive access to a prediabetes (PreD) CDS tool. Between October 2016 and December 2019, primary care clinicians (PCPs) received Pre-D CDS alerts during visits with adult patients identified with prediabetes and who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP Pre-D CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Study outcomes included total modifiable CV risk, six modifiable CV risk factors, use of CV medications, and referrals. The Consolidated Framework for Implementation Research was used to examine CDS implementation processes. DISCUSSION: This cluster-randomized pragmatic trial allowed PCPs the opportunity to improve CV risk in a timely manner for patients with prediabetes. Effectiveness will be assessed using an intent-to-treat analysis. Implementation processes and outcomes will be assessed through interviews, surveys, and electronic health record data harvested by the CDS tool itself. Pre-implementation interviews and activities identified key strategies to incorporate as part of the Pre-D CDS implementation process to ensure acceptability and high use rates. Analyses are ongoing and trial results are expected in mid-2021.

Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.

BACKGROUND: We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. METHODS/DESIGN: Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit: age 18-75, laboratory criteria for stage 3 or 4 CKD (eGFR 15-59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes. DISCUSSION: We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.

Challenges involved in establishing a web-based clinical decision support tool in community health centers.

Implementation lessons: Establishing a shared 'hub-and-spoke,' web-based clinical decision support system (CDSS) in an EHR shared by >600 community health centers incurred a myriad of challenges, which are summarized here to guide others seeking to use similar CDSS. Legal and compliance challenges involved ensuring secure data exchanges, determining which entity maintains data records, and deciding which data are sent to the CDSS. Technical challenges involved using lab data from multiple sources and improving the CDSS' cache routine performance in its new setting. Clinical implementation challenges involved identifying optimal strategies for generating data on CDSS use rates, modifying the CDSS functionality for obtaining clinician/staff feedback, and customizing the risk thresholds that trigger the CDSS for the new setting.

Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure.

BACKGROUND: Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S. POPULATION: Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care. AIMS/OBJECTIVES: To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research. METHODS: The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects. CONCLUSION: This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.

Clinical decision support directed to primary care patients and providers reduces cardiovascular risk: a randomized trial.

Objective: To test the hypothesis that use of a clinical decision support (CDS) system in a primary care setting can reduce cardiovascular (CV) risk in patients. Materials and Methods: Twenty primary care clinics were randomly assigned to usual care (UC) or CDS. For CDS clinic patients identified algorithmically with high CV risk, rooming staff were prompted by the electronic health record (EHR) to print CDS that identified evidence-based treatment options for lipid, blood pressure, weight, tobacco, or aspirin management and prioritized them based on potential benefit to the patient. The intention-to-treat analysis included 7914 adults who met high CV risk criteria at an index clinic visit and had at least one post-index visit, accounted for clustering, and assessed impact on predicted annual rate of change in 10-year CV risk over a 14-month period. Results: The CDS was printed at 75% of targeted visits, and providers reported 85% to 98% satisfaction with various aspects of the intervention. Predicted annual rate of change in absolute 10-year CV risk was significantly better in CDS clinics than in UC clinics (-0.59% vs. +1.66%, -2.24%; P < .001), with difference in 10-year CV risk at 12 months post-index favoring the CDS group (UC 24.4%, CDS 22.5%, P < .03). Discussion: Deploying to both patients and providers within primary care visit workflow and limiting CDS display and print burden to two mouse clicks by rooming staff contributed to high CDS use rates and high provider satisfaction. Conclusion: This EHR-integrated, web-based outpatient CDS system significantly improved 10-year CV risk trajectory in targeted adults.

Clinical Decision Support for Recognition and Management of Hypertension: A Randomized Trial.

OBJECTIVES: Although blood pressure (BP) is routinely measured in outpatient visits, elevated BP and hypertension are often not recognized. We evaluated whether an electronic health record-linked clinical decision support (CDS) tool could improve the recognition and management of hypertension in adolescents. METHODS: We randomly assigned 20 primary care clinics within an integrated care system to CDS or usual care. At intervention sites, the CDS displayed BPs and percentiles, identified incident hypertension on the basis of current or previous BPs, and offered tailored order sets. The recognition of hypertension was identified by an automated review of diagnoses and problem lists and a manual review of clinical notes, antihypertensive medication prescriptions, and diagnostic testing. Generalized linear mixed models were used to test the effect of the intervention. RESULTS: Among 31 579 patients 10 to 17 years old with a clinic visit over a 2-year period, 522 (1.7%) had incident hypertension. Within 6 months of meeting criteria, providers recognized hypertension in 54.9% of patients in CDS clinics and 21.3% of patients in usual care (P ≤ .001). Clinical recognition was most often achieved through visit diagnoses or documentation in the clinical note. Within 6 months of developing incident hypertension, 17.1% of CDS subjects were referred to dieticians or weight loss or exercise programs, and 9.4% had additional hypertension workup versus 3.9% and 4.2%, respectively (P = .001 and .046, respectively). Only 1% of patients were prescribed an antihypertensive medication within 6 months of developing hypertension. CONCLUSIONS: The CDS had a significant, beneficial effect on the recognition of hypertension, with a moderate increase in guideline-adherent management.

Potential Misclassification of Blood Pressure Status in Children and Adolescents With Short or Tall Stature.

Blood pressure (BP) is measured in percentiles that are adjusted for sex, age, and height percentile in children and adolescents. Standard tables for the conversion of BP percentiles do not present exact BP percentile cutoffs for extremes in stature, either short (<5th percentile) or tall (>95th percentile). An algorithm can be used to calculate exact BP percentiles across a range of height z scores. We compared values from standard BP tables with exact calculations of BP percentiles to see which were better at identifying hypertension in more than 5,000 children with either short or tall stature. Study subjects were 3-17-year-old patients within HealthPartners Medical Group, an integrated health care delivery system in Minnesota, at any time between 2007 and 2012. Approximately half of the subjects who met the criteria for hypertension using exact calculation would be misclassified as normal using available thresholds in the published BP tables instead of the recommended algorithm, which was not included in the tables.

TeenBP: Development and Piloting of an EHR-Linked Clinical Decision Support System to Improve Recognition of Hypertension in Adolescents.

CONTEXT: Blood pressure (BP) is routinely measured in children and adolescents during primary care visits. However, elevated BP or hypertension is frequently not diagnosed or evaluated further by primary care providers. Barriers to recognition include lack of clinician buy-in, competing priorities, and complexity of the standard BP tables. CASE DESCRIPTION: We have developed and piloted TeenBP- a web-based, electronic health record (EHR) linked system designed to improve recognition of prehypertension and hypertension in adolescents during primary care visits. MAJOR THEMES: Important steps in developing TeenBP included the following: review of national BP guidelines, consideration of clinic workflow, engagement of clinical leaders, and evaluation of the impact on clinical sites. Use of a web-based platform has facilitated updates to the TeenBP algorithm and to the message content. In addition, the web-based platform has allowed for development of a sophisticated display of patient-specific information at the point of care. In the TeenBP pilot, conducted at a single pediatric and family practice site with six clinicians, over a five-month period, more than half of BPs in the hypertensive range were clinically recognized. Furthermore, in this small pilot the TeenBP clinical decision support (CDS) was accepted by providers and clinical staff. Effectiveness of the TeenBP CDS will be determined in a two-year cluster-randomized clinical trial, currently underway at 20 primary care sites. CONCLUSION: Use of technology to extract and display clinically relevant data stored within the EHR may be a useful tool for improving recognition of adolescent hypertension during busy primary care visits. In the future, the methods developed specifically for TeenBP are likely to be translatable to a wide range of acute and chronic issues affecting children and adolescents.

Educating resident physicians using virtual case-based simulation improves diabetes management: a randomized controlled trial.

PURPOSE: To test a virtual case-based Simulated Diabetes Education intervention (SimDE) developed to teach primary care residents how to manage diabetes. METHOD: Nineteen primary care residency programs, with 341 volunteer residents in all postgraduate years (PGY), were randomly assigned to a SimDE intervention group or control group (CG). The Web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models. Eighteen distinct learning cases (L-cases) were assigned to SimDE residents over six months from 2010 to 2011. Impact was assessed using performance on four virtual assessment cases (A-cases), an objective knowledge test, and pre-post changes in self-assessed diabetes knowledge and confidence. Group comparisons were analyzed using generalized linear mixed models, controlling for clustering of residents within residency programs and differences in baseline knowledge. RESULTS: The percentages of residents appropriately achieving A-case composite clinical goals for glucose, blood pressure, and lipids were as follows: A-case 1: SimDE = 21.2%, CG = 1.8%, P = .002; A-case 2: SimDE = 15.7%, CG = 4.7%, P = .02; A-case 3: SimDE = 48.0%, CG = 10.4%, P < .001; and A-case 4: SimDE = 42.1%, CG = 18.7%, P = .004. The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants. CONCLUSIONS: A virtual case-based simulated diabetes education intervention improved diabetes management skills, knowledge, and confidence for primary care residents.

Using simulation technology to teach diabetes care management skills to resident physicians.

BACKGROUND: Simulation is widely used to teach medical procedures. Our goal was to develop and implement an innovative virtual model to teach resident physicians the cognitive skills of type 1 and type 2 diabetes management. METHODS: A diabetes educational activity was developed consisting of (a) a curriculum using 18 explicit virtual cases, (b) a web-based interactive interface, (c) a simulation model to calculate physiologic outcomes of resident actions, and (d) a library of programmed feedback to critique and guide resident actions between virtual encounters. Primary care residents in 10 U.S. residency programs received the educational activity. Satisfaction and changes in knowledge and confidence in managing diabetes were analyzed with mixed quantitative and qualitative methods. RESULTS: Pre- and post-education surveys were completed by 92/142 (65%) of residents. Likert scale (five-point) responses were favorably higher than neutral for general satisfaction (94%), recommending to colleagues (91%), training adequacy (91%), and navigation ease (92%). Finding time to complete cases was difficult for 50% of residents. Mean ratings of knowledge (on a five-point scale) posteducational activity improved by +0.5 (p < .01) for use of all available drug classes, +0.9 (p < .01) for how to start and adjust insulin, +0.8 (p < .01) for interpreting blood glucose values, +0.8 (p < .01) for individualizing treatment goals, and +0.7 (p < .01) for confidence in managing diabetes patients. CONCLUSIONS: A virtual diabetes educational activity to teach cognitive skills to manage diabetes to primary care residents was successfully developed, implemented, and well liked. It significantly improved self-assessed knowledge and confidence in diabetes management.