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.

Association of an Automated Blood Pressure Measurement Quality Improvement Program With Terminal Digit Preference and Recorded Mean Blood Pressure in 11 Clinics.

Importance: Terminal digit preference has been shown to be associated with inaccurate blood pressure (BP) recording. Objective: To evaluate whether converting from manual BP measurement with aneroid sphygmomanometers to automated BP measurement was associated with terminal digit preference, mean levels of recorded BP, and the rate at which hypertension was diagnosed. Design, Setting, and Participants: This quality improvement study was conducted from May 9, 2021, to March 24, 2022, using interrupted time series analysis of medical record data from 11 primary care clinics in a single health care system from April 2008 to April 2015. The study population was patients aged 18 to 75 years who had their BP measured and recorded at least once during the study period. Exposures: Manual BP measurement before April 2012 vs automated BP measurement with the Omron HEM-907XL monitor from May 2012 to April 2015. Main Outcomes and Measures: The main outcome was the distribution of terminal digits and mean systolic BP (SBP) values obtained during 4 years of manual measurement vs 3 years of automated measurement, assessed using a generalized linear mixed regression model with a random intercept for clinic and adjusted for seasonal fluctuations and patient demographic and clinical characteristics. Results: The study included 1 541 227 BP measurements from 225 504 unique patients during the entire study period, with 849 978 BP measurements from 165 137 patients (mean [SD] age, 47.1 [15.2] years; 58.2% female) during the manual measurement period and 691 249 measurements from 149 080 patients (mean [SD] age, 48.4 [15.3] years; 56.3% female) during the automated measurement period. With manual measurement, 32.8% of SBP terminal digits were 0 (20% was the expected value because nursing staff was instructed to record BP to the nearest even digit). This proportion decreased to 12.4% during the automated measurement period (expected value, 10%) when both even and odd digits were to be recorded. After automated measurement was implemented, the mean SBP estimated with statistical modeling increased by 5.09 mm Hg (95% CI, 4.98-5.19 mm Hg). Fewer BP values recorded during the automated than the manual measurement period were below 140/90 mm Hg (69.9% vs 84.3%; difference, -14.5%; 95% CI, -14.6% to -14.3%) and below 130/80 mm Hg (42.1% vs 60.0%; difference, -17.9%; 95% CI, -18.0% to -17.7%). The proportion of patients with a diagnosis of hypertension was 4.3 percentage points higher (23.4% vs 19.1%) during the automated measurement period. Conclusions and Relevance: In this quality improvement study, automated BP measurement was associated with decreased terminal digit preference and significantly higher mean BP levels. The method of BP measurement was also associated with the rate at which hypertension was diagnosed. These findings may have implications for pay-for-performance programs, which may create an incentive to record BP levels that meet a particular goal and a disincentive to adopt automated measurement of BP.

Primary care physician perspectives on using team care in clinical practice.

BACKGROUND: Primary care physicians were prompted to refer eligible patients with uncontrolled hypertension (HTN) to a program that offered home blood pressure telemonitoring and pharmacist care management. Understanding attitudes, barriers and facilitators, and use of team care in this program provides insight into how physicians incorporate team care into their practice. OBJECTIVE: To understand physician attitudes and use of team care in the context of a study intervention that included telehealth care with pharmacist care management. METHODS: Clinicians who were part of the telehealth intervention arm of the Hyperlink 3 study and had at least 20 opportunities to refer an eligible patient with HTN to a clinical pharmacist were invited to be interviewed. Nine physician interviews were conducted, recorded, and transcribed. Each interview lasted approximately 30 minutes and followed an interview guide, allowing for some variation and deeper dives into content on the basis of the clinician response. Three research staff coded each interview and sorted coded text to identify patterns at the physician level and then identified themes across interviews using a comparative process. RESULTS: Physicians had an overall positive attitude about team care. Communication, access, trust, and perceived role competency of team members influenced physician engagement in team care. Individualized practice styles influenced how physicians used team care and which care team members they involved most often. All physicians felt that their individual style best achieved high-quality care. CONCLUSION: For health care teams to be most effective, an understanding of how a physician's practice style influences their use of team care is likely to be more successful than a one-size-fits-all approach. Incorporating practice style into the key factors necessary for high-functioning teams, such as communication, access, and trust, is necessary for health care teams to thrive.

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.

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists.

OBJECTIVES: The Hyperlink trial tested a 12-month intervention of home blood pressure (BP) telemonitoring with pharmacist case management in adults with uncontrolled hypertension. The intervention resulted in improved BP control compared with usual care at both 6 (72% vs. 45%; P < 0.001) and 12 months (71% vs. 53%; P = 0.005). We sought to investigate factors contributing to intervention success. DESIGN: Mixed-methods analysis of process of care data, patient focus groups, and pharmacist interviews. PARTICIPANTS: Data from 228 intervention patients were examined from the original 450 patients randomly assigned from 16 primary care clinics. Five patient focus groups and 4 pharmacist interviews were conducted to ascertain the patient and pharmacist perspective. Focus group and interview data were coded, and themes relevant to pharmacists were identified. OUTCOME MEASURES: Home BP readings of less than 135/85 mm Hg and patient focus group and pharmacist interview themes. RESULTS: Mean BP at the intake visit was 148/85 mm Hg. Antihypertensive medications were adjusted in 10% of patients at the initial in-person visit, 33% at phone visit 1, 36% at phone visit 2, and 19% at phone visit 3. Thereafter, medication changes declined. The mean home BP for patients at the first phone visit was 136/80 mm Hg, 126/74 mm Hg at 3 months, and 123/73 mm Hg at 5 months, with little change thereafter. Key components of success from patient and pharmacist interviews included a strong patient-pharmacist relationship, individualized treatment plans, and frequent phone contact with the pharmacist. CONCLUSION: Frequent adjustments to the antihypertensive treatment regimen based on home BP telemonitoring resulted in rapid lowering of BP. Our results suggest that an intensive telephone-based intervention with the key components of medication adjustments, a strong patient and pharmacist relationship, and individualized treatment plans can achieve BP control in only 3 months in many patients with uncontrolled hypertension.