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.

Improving Care for Patients with Chronic Hepatitis B via Establishment of a Disease Registry.

In the United States, there is poor clinician adherence to the American Association for the Study of Liver Disease and other guidelines for chronic hepatitis B virus (CHB) management. This prospective cohort study evaluated whether a CHB registry improves CHB management. We included patients with CHB aged ≥ 18 years and who had a clinical encounter during September 1, 2016-August 31, 2019. We divided patients into three groups based on care received before September 1, 2019: 1) CIH: primary care clinician at HealthPartners Center for International Health, 2) GI: not CIH and seen by gastroenterology within previous 18 months, and 3) primary care (PC): not CIH and not seen by gastroenterology within previous 18 months. We created and implemented a CHB registry at CIH that allowed staff to identify and perform outreach to patients overdue for CHB management. Patients with laboratory testing (i.e., alanine transaminase and hepatitis B virus DNA) and hepatocellular carcinoma screening in the previous 12 months were considered up to date (UTD). We compared UTD rates between groups at baseline (September 1, 2019) and pilot CHB registry end (February 28, 2020). We evaluated 4,872 patients, 52% of whom were female: 213 CIH, 656 GI, and 4,003 PC. At baseline, GI patients were most UTD (69%) followed by CIH (51%) and PC (11%). At pilot end the percent of UTD patients at CIH increased by 11%, GI decreased by 10%, and PC was unchanged. CHB registry use standardized care and increased the percent of CHB patients with recent laboratory testing and HCC screening.

Communication about Sexual Consent and Refusal: A Learning Tool and Qualitative Study of Adolescents' Comments on a Sexual Health Website.

Sexual communication skills are needed to create healthy romantic relationships. Arguably, these skills also can be used to prevent some instances of unwanted sex. This study presents a qualitative analysis of adolescents' comments after reading a teen-friendly article on sexual consent as part of a web-based sexual health promotion intervention. The sample was comprised predominantly of female adolescents recruited from a Midwest urban region in the United States. Adolescents varied with respect to self-efficacy to request, provide, and deny consent, as well as the perceived need to ask for consent in the context of established relationships. Many adolescents perceived that nonverbal methods of communication were sufficient to request, provide, or deny sexual consent. Factors that make it difficult to discuss sexual boundaries and say "no" to unwanted sex included low self-efficacy and an underlying desire to nurture or preserve a relationship. Cultural norms must be changed to support verbal, affirmative sexual consent. In addition, adolescents must be aided in the development of skills to request sexual consent, say "yes" to specific activities, and say "no" to others. Without supportive norms and skills to enhance self-efficacy, adolescents may be unwilling to engage in verbal communication about sexual consent and boundaries.

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.

Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018.

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. Design, Setting, and Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. Main Outcomes and Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013. Conclusions and Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.

An Interactive Website to Reduce Sexual Risk Behavior: Process Evaluation of TeensTalkHealth.

BACKGROUND: Different theoretical frameworks support the use of interactive websites to promote sexual health. Although several Web-based interventions have been developed to address sexual risk taking among young people, no evaluated interventions have attempted to foster behavior change through moderated interaction among a virtual network of adolescents (who remain anonymous to one another) and health professionals. OBJECTIVE: The objective was to conduct a summative process evaluation of TeensTalkHealth, an interactive sexual health website designed to promote condom use and other healthy decision making in the context of romantic and sexual relationships. METHODS: Evaluation data were obtained from 147 adolescents who participated in a feasibility and acceptability study. Video vignettes, teen-friendly articles, and other content served as conversation catalysts between adolescents and health educators on message boards. RESULTS: Adolescents' perceptions that the website encouraged condom use across a variety of relationship situations were very high. Almost 60% (54/92, 59%) of intervention participants completed two-thirds or more of requested tasks across the 4-month intervention. Adolescents reported high levels of comfort, perceived privacy, ease of website access and use, and perceived credibility of health educators. Potential strategies to enhance engagement and completion of intervention tasks during future implementations of TeensTalkHealth are discussed, including tailoring of content, periodic website chats with health educators and anonymous peers, and greater incorporation of features from popular social networking websites. CONCLUSIONS: TeensTalkHealth is a feasible, acceptable, and promising approach to complement and enhance existing services for youth.