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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.

Background: Addressing the opioid epidemic would benefit from primary care clinicians identifying and managing opioid use disorder (OUD) during routine clinical encounters, but current rates are low. Clinical decision support (CDS) systems are a promising way to facilitate such interactions, but will clinicians use them? Methods: We iteratively conducted semi-structured interviews with 8 purposively sampled primary care clinicians participating in a pilot OUD-CDS study to identify attitudes toward discussing OUD and preferences for support in doing so. Five of them had used a pilot version of the CDS for 6 months, while the others were in comparison clinics. Interviews were recorded, transcribed, and analyzed by a multi-disciplinary group of experienced researchers, using an editing organizing style where the analysts independently highlighted relevant text and then discussed to reach a consensus on themes. Results: We identified five themes: 1. Primary care is the right place to address OUD. 2. Both clinician-patient and clinician-clinician relationships affect how and whether clinicians address OUD in a particular patient encounter. 3. The main challenges are limited time and competing priorities for these complex patients. 4. Although a CDS for OUD could be very helpful, it must meet different needs for different clinicians and clinical situations and be simple to use. 5. For optimal benefit, the CDS needs to be complemented by supportive organizational policies and systems as well as local clinician encouragement. Conclusions: With the right design and a supportive organization, these primary care clinicians believe a CDS could help them regularly identify and address OUD among their patients as long as it incorporates their concerns about relationships, competing priorities, patient complexity, and user simplicity.

BACKGROUND: The use of diagnostic imaging with computed tomography (CT) has risen significantly, increasing cumulative life-time exposure to ionizing radiation for patients and raising concerns about increased cancer risk. Lowering the doses would reduce concerns about associated cancer risks. PURPOSE: To determine organizational leaders’ perceptions of barriers to optimizing radiation dose in computed tomography (CT). MATERIALS AND METHODS: An observational study using semi-structured interviews conducted with 26 organizational leaders from 19 health care systems in the United States, Europe, and Japan. Interviews focused on approaches the organizations used to optimize radiation dose and barriers encountered. Data were analyzed using a directed content analysis approach. RESULTS: Analysis identified six primary barriers to dose optimization: 1) resistance to change, 2) limited time and resources, 3) complex organizational structure, 4) lack of leadership support, 5) variations in CT equipment, and 6) variability in CT protocols. CONCLUSION: Barriers to optimizing CT dose across diverse health care organizations were described by organizational leaders tasked with implementing and improving CT imaging. They identified six consistent themes that reflected barriers to optimizing radiation dose at the organizational level. These barriers impeded efforts by health care organizations to optimize radiation doses to patients from CT imaging. Identifying barriers early in any improvement process is an important first step in making meaningful and sustained change.

Introduction: Patient ratings of their experience of care are part of the “Triple Aim”. Improvements are highly valued by health care organizations, but are hard to achieve. Hypothesis: We tested the effect of a telehealth intervention on satisfaction with hypertension care. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in HealthPartners, an integrated health system in Minnesota and Wisconsin. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). CC patients received guideline-based hypertension care in face-to-face visits. TC patients were additionally offered home blood pressure (BP) telemonitoring with pharmacist care management. Patients were surveyed at baseline and after 6 months of study enrollment and asked to rate their hypertension care in the previous 6 months on a scale of 0-10. We compared change in the proportion of patients rating their care at the highest level (9 or 10). Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50% completion) and 1301 (76%) of those completing the baseline survey completed the 6 month survey (goal 75% completion). Baseline survey respondents’ mean age was 62 y (non-respondents 58 y), 46% were men (non-respondents 48%), 19% were black (non-respondents 20%), and mean BP was 164/93 mm Hg (non-respondents 164/95 mm Hg.) Nearly all patients (over 90%) took antihypertensive medications (median 2). Hypertension care ratings of 9 or 10 were 27.9% at baseline and 30.2% at 6 months in CC, compared with 29.0% at baseline and 39.5% at 6 months in TC. The odds ratio (OR) for change over time in 9 or 10 ratings was 1.11 (95% CI 0.87 - 1.42) in CC, and 1.61 (95% CI 1.26 - 2.07) in TC. The OR for change in 9 or 10 ratings over time in TC vs CC was 1.45 (95% CI 1.03 - 2.06). Conclusions: Home BP telemonitoring with pharmacist care management increased the proportion of patients who highly rated their experience of hypertension care, even though only a minority of the TC patients received the intervention.

Introduction: Telehealth and remote monitoring have become critical to patient access to care during the COVID-19 pandemic. We measured the effect of a telehealth care intervention on frequency, sharing methods, and clinical usage of home blood pressure (BP) measurements. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in an integrated health system. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). TC patients were offered home BP telemonitoring with pharmacist care management. Patients were surveyed at baseline (Nov 2017 - Apr 2019) and after 6 mo of study enrollment. Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50%) and 1301 (76%) of those completing the baseline survey completed the 6 mo survey (goal 75%). Baseline survey respondents' mean age was 62, 46% were men, 19% were black, and mean BP was 164/93 mm Hg. Nearly all patients (>90%) took antihypertensive medications (median 2). The odds ratio (OR) for change in measuring BP > 2 times/week vs. less often was 0.97 (95% CI 0.87 - 1.42) in CC, and 2.01 (95% CI 1.56 - 2.59) in TC. The OR for change in frequent measurement in TC vs CC was 2.08 (95% CI 1.45 - 2.97). Conclusions: A telehealth care intervention markedly increased the frequency of home BP self- monitoring, electronic data sharing, and data-driven BP medication changes, even though only a minority of TC patients received the intervention.

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21–1.13], P =0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22–1.08], P =0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00781365.

Background Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice. Objective To analyze the economic outcomes of the Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure (Hyperlink) study, a cluster randomized controlled trial which used home blood pressure telemonitoring and pharmacist case management to achieve better blood pressure control in patients with uncontrolled hypertension. Methods A prospective analysis compared differences in medical costs and encounters in the Hyperlink telemonitoring intervention and usual care groups in the 12 months pre- and post-enrollment using medical and pharmacy insurance claims from a health care sector perspective. Generalized estimating equation models were used to estimate differences between groups over time. These results, combined with previously published prospective study results on intervention costs and blood pressure outcomes, were used to estimate cost-effectiveness measures for blood pressure control and reduction. Findings Total medical costs in the intervention group were lower compared with the usual care group by an average of $281 per person, but this difference was not statistically significant. Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group. Statistically significant differences were found in lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs. Patterns in medical costs were similar for medical encounters. On average, the intervention cost $7337 per person achieving hypertension control and $139 or $265 per mm Hg reduction in systolic or diastolic blood pressure, respectively. Conclusions Home blood pressure monitoring and pharmacist case management to improve hypertension care can be implemented without increasing, and potentially reducing, overall medical care costs.

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.

SummaryWhat is known and objective Hypertension is a leading cause of death and major contributor to heart attacks, strokes, heart and kidney failure. Antihypertensive (HTN medication) non-adherence contributes to uncontrolled hypertension. Effective initiatives to improve uncontrolled hypertension include a team-based approach with home blood pressure (BP) monitoring. Our study objective was to evaluate whether objectively measured medication adherence was influenced by home BP telemonitoring and pharmacist management. Methods We analysed HTN medication adherence in 240 patients who received home BP telemonitoring and pharmacist intervention (TI). Adherence was measured based on prescription fills and the proportion of days covered (PDC). HTN medications continued pre- to post-baseline were similar for telemonitoring intervention (TI) and usual care (UC) patients (rate ratio = 1·00, P = 0·90). Results and discussion More HTN medications were discontinued pre- to post-baseline in TI patients (rate ratio = 1·38, P = 0·04). Similarly, more HTN medications were added in TI patients (rate ratio = 2·46, P < 0·001). The proportion with a mean PDC ≥ 0·8 for HTN medications added after baseline and overall adherence did not differ between groups. What is new and conclusion Medication adherence was high in both groups; however, medication adherence was not significantly altered by the intervention. There were more medication modifications and greater medication intensification among TI patients.

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.

The 2017 ACC/AHA hypertension guideline strongly recommends systematic follow-up and monitoring of treatment using team-based care and telehealth, based on Level A evidence. However, different models for organizing team-based care and telehealth have not been compared. We describe the design of a PCORI-funded pragmatic trial with the following objectives: Aim 1) compare the effects on BP and patient-reported outcomes of two models of team-based care for uncontrolled hypertension, and Aim 2) study how the two models are carried out in the real-world setting of a large health system. The study is a 5-year cluster-randomized trial in 2000 patients age 18-85 with uncontrolled hypertension cared for in 21 primary care clinics at HealthPartners, a large integrated healthcare system in the Twin Cities area of Minnesota and western Wisconsin. Clinic-based care uses recommended best practices and face-to-face visits primarily with physicians, nurses and medical assistants. The telehealth care approach adapts a research-tested model with systematic use of home BP telemonitoring and home-based telehealth care coordinated by a clinical pharmacist or nurse practitioner. Patients in both groups are recruited directly from primary care clinics using electronic health record (EHR) prompts. Exclusions are few: pregnancy, advanced kidney disease, hospice care, and nursing home residence. The primary outcomes for Aim 1 are:1) change in BP over 12 months, and 2) change in patient-reported outcomes over six months, including treatment side effects, experiences with hypertension care, self-monitoring rates, and confidence in self-care. Secondary outcomes include other heart- and stroke-related risk factors and safety. Patients contributed extensively to the selection of the outcomes. Outcomes are collected over 24 months without reliance on research visits: patient-reported outcomes are measured by surveys and BP and other clinical outcomes are measured using routinely collected data documented in the EHR. We also use EHR data supplemented by qualitative data to assess how the two care models are carried out in practice. The results of this comparative effectiveness trial will assess pragmatic methods for implementing hypertension guideline recommendations.

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 =.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. SETTING AND 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

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

Objective. We assessed young African American women's understanding of “dual protection” (DP) (i.e., strategies that simultaneously protect against unintended pregnancies and sexually transmitted diseases [STDs]) and how relationship factors influence their use of DP methods. Methods. We conducted 10 focus groups with African American women ( n=51) aged 15–24 years in Atlanta, Georgia, to identify barriers to and facilitators of their DP use. Focus group participants also completed a brief self-administered questionnaire that assessed demographics and sexual behaviors. We analyzed focus group data by theme: relationships, planning for sex, pregnancy intentions, STD worries, the trade-off between pregnancy and STDs, attitudes toward condoms and contraceptives, and understanding of DP. Results. From the questionnaire, 51% of participants reported that an STD would be the “worst thing that could happen,” and 26% reported that being pregnant would be “terrible.” Focus group data suggested that most participants understood what DP was but thought it was not always feasible. Relationship factors (e.g., trust, intimacy, length of relationship, and centrality) affected pregnancy intentions, STD concerns, and use of DP. Social influences (e.g., parents) and pregnancy and STD history also affected attitudes about pregnancy, STDs, and relationships. Conclusions. Although participants identified risks associated with sex, a complex web of social and relationship factors influenced the extent to which they engaged in protective behavior The extent to which relationship factors influence DP may reflect developmental tasks of adolescence and should be considered in any program promoting sexual health among young African American women.

This paper reports subgroup analysis of a successful cluster-randomized trial to identify attributes of hypertensive patients who benefited more or less from an intervention combining blood pressure (BP) telemonitoring and pharmacist management. The end point was BP 140/90 mm Hg at 6-month follow-up. Fourteen baseline patient characteristics were selected a priori as subgroup variables. Among the 351 trial participants, 44% were female, 84% non-Hispanic white, mean age was 60.9 years, and mean BP was 149/86 mm Hg. The overall adjusted odds ratio for BP control in the intervention versus usual care group was 3.64 (P .001). The effect of the intervention was significantly larger in patients who were younger (interaction P = .02), did not have diabetes (P = .005), had high baseline diastolic BP (P = .02), added salt less than daily in food preparation (P = .007), and took 0-2 (rather than 3-6) antihypertensive medication classes at baseline (P = .02). These findings may help prioritize patients for whom the intervention is most effective.

Communication technology is a central feature of young people's lives, but its role in romantic and sexual relationships has not been thoroughly examined. This article describes how young adults use communication technology for partnering across relationship stages (formation, maintenance, and dissolution) and types (serious/casual), and proposes implications of usage in relationships. This study analyzed qualitative data from a five-week, prospective, coital diary method with related debriefing interviews (N = 70) of African American and Puerto Rican men and women aged 18 to 25 years in Hartford and Philadelphia. Cell phones, including calls, text messaging, and mobile Internet, were the most common forms of communication technology used for partnering goals. Participants reported using cell phones to pursue partnering goals across all relationship stages, including formation (meeting, screening, and getting to know new partners), maintaining existing relationships, and breaking up. Cell phone uses depended on the type of relationship (serious/casual) and the participants' intentions and desires. Results indicated that cell phones are an important element of communication among young adults in romantic and sexual relationships. Specific features of cell phone communication shape the process and context of partnering. Future research should explore emerging communication technologies and implications for psychosocial development, dating violence, and sexual behavior.

Importance Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (−10.7, −9.7, and −6.6 mm Hg, respectively). Objectives To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care. Design, Setting, and Participants Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015. Interventions A home BP telemonitoring intervention with pharmacist management or usual care. Main Outcomes and Measures Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit. Results Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was −2.5 mm Hg (95% CI, −6.3 to 1.2 mm Hg;P = .18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of −1.0 mm Hg (95% CI, −3.2 to 1.2 mm Hg;P = .37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months. Conclusions and Relevance This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases. Trial Registration ClinicalTrials.gov Identifier:NCT00781365

It is important to understand which components of successful multifaceted interventions are responsible for study outcomes, since some components may be more important contributors to the intervention effect than others.We conducted a mediation analysis to determine which of seven factors had the greatest effect on change in systolic blood pressure (BP) after 6 months in a trial to improve hypertension control.The study was a preplanned secondary analysis of a cluster-randomized clinical trial. Eight clinics in an integrated health system were randomized to provide usual care to their patients (n = 222), and eight were randomized to provide a telemonitoring intervention (n = 228).Four hundred three of 450 trial participants completing the 6-month follow-up visit were included.Intervention group participants received home BP telemonitors and transmitted measurements to pharmacists, who adjusted medications and provided advice to improve adherence to medications and lifestyle modification via telephone visits.Path analytic models estimated indirect effects of the seven potential mediators of intervention effect (defined as the difference between the intervention and usual care groups in change in systolic BP from baseline to 6 months). The potential mediators were change in home BP monitor use, number of BP medication classes, adherence to BP medications, physical activity, salt intake, alcohol use, and weight.The difference in change in systolic BP was 11.3 mmHg. The multivariable mediation model explained 47 % (5.3 mmHg) of the intervention effect. Nearly all of this was mediated by two factors: an increase in medication treatment intensity (24 %) and increased home BP monitor use (19 %). The other five factors were not significant mediators, although medication adherence and salt intake improved more in the intervention group than in the usual care group.Most of the explained intervention effect was attributable to the combination of self-monitoring and medication intensification. High adherence at baseline and the relatively low intensity of resources directed toward lifestyle change may explain why these factors did not contribute to the improvement in BP.

Background/AimsThe Hyperlink trial tested a 12-month intervention combining home blood pressure (BP) telemonitoring with pharmacist case management in patients with uncontrolled hypertension. The intervention resulted in improved BP control compared to usual care at both 6 and 12 months (57% vs. 30%, P = 0.001). The mean number of medication classes increased compared to usual care (0.63 vs. 0.22, P 80%) in only about half of patients, but at subsequent phone visits in >90% of patients. The mean home BP recorded by the pharmacists for patients at the first phone visit was 136/80, and fell steadily to a mean of 126/74 at 3 months, and thereafter declined more slowly to 123/73 at 5 months, with little change thereafter.ConclusionsImproved adherence and appropriate adjustments to the antihypertensive treatment regimen based on home BP telemonitoring resulted in rapid lowering of BP over a 3-month period. Our results imply that intensive intervention may only be needed for about 3 months in many patients with uncontrolled hypertension.

Background/Aims Patients with high blood pressure (BP) visit a physician on average 4 times per year though fewer than half achieve BP control. Practical, effective, and sustainable models are needed to improve BP management. Hyperlink is a clinic-randomized trial testing an intervention that combines home BP telemonitoring with pharmacist case management in patients with uncontrolled hypertension.

Background: Patients with high blood pressure (BP) visit a physician on average 4 times per year, but fewer than half have controlled BP. Practical, effective, and sustainable models are needed to improve BP management. Accumulating evidence supports the effectiveness of team-based models for care and home telemonitoring, but few studies have examined whether effects persist after intervention completion. Aims: Hyperlink is a clinic-randomized trial testing an intervention combining home BP telemonitoring with pharmacist case management in patients with uncontrolled hypertension. Methods: We enrolled 450 patients with uncontrolled BP from 16 primary care clinics, 8 randomized to usual care (UC, 222 patients) and 8 to telemonitoring intervention (TI, 228 patients). TI patients received home telemonitors that transmit BP data to a secure database. Pharmacists met with TI patients by phone and adjusted drug therapy based on home BP data. The intervention had an ‘intensive’ phase for the first 6 months and a ‘maintenance’ phase with less frequent pharmacist support through 12 months. Patients were followed through 18 months to observe durability of effects on BP control ( Results: Enrollees were 45% female, 82% white, and 12% black, with mean age of 61 years. Mean BP at baseline was 148/85 mm Hg in both groups. Results indicate a significant effect on BP control in the TI group. Around 71% of TI patients achieved BP control at each time point, while UC BP control was 45.2% at 6 months, 52.8% at 12 months and 57.1% at 18 months. The mean difference in BP change (mm Hg) between groups from baseline was -10.7/-6.0 at 6 months, -9.7/-5.1 at 12 months, and -6.6/-3.0 at 18 months (Table 1, attached). Mean number of drugs per patient increased in TI from 1.5 at baseline to 2.2 at 6 months, persisting through 18 months. A small increase was observed in UC, with 1.4 at baseline, 1.6 at 6 and 12 months, and 1.7 at 18 months. Conclusions: Home telemonitoring with pharmacist case management was effective at reducing BP for 12 months, with a persistent effect 6 months later. Further long-term follow-up of study participants is planned.

Background/Aims: In the US heart disease is the number one cause of death and stroke is the leading cause of adult disability. Early treatment, received within three-hours after a heart attack or a stroke, is critical to lowering the risk of disability and/or death. Understanding the symptoms and signs of heart attacks and strokes are important not only in saving lives, but also in preserving quality of life. Findings from recent research have yielded that the prevalence of cardiovascular disease risk factors are higher in rural populations, suggesting that adults living in rural locales may be at higher risk for heart attack and/or stroke. Knowledge of heart attack and stroke symptomology as well as calling 911 as the appropriate first response to suspected heart attack or stroke are essential first steps in seeking care. This study sought to examine the knowledge of heart attack and stroke symptoms among rural adults in comparison to non-rural adults living in the US. Methods: Using multivariate techniques, a cross-sectional analysis of an amalgamated multi-year Behavioral Risk Factor Surveillance Survey (BRFSS) database was performed. The dependent variable for this analysis was low heart attack and stroke knowledge score. The covariates for the analysis were: age, sex, race/ethnicity, annual household income, attained education, health insurance status, health care provider (HCP), timing of last routine medical check-up, medical care deferment, self-defined health status and geographic locale. Results: Logistic regression analysis revealed that those US adults who had low composite heart attack and stroke knowledge scores were more likely to be rural (OR=1.218 95%CI 1.216-1.219) rather than non-rural residents. Furthermore, those with low scores were more likely to be: male (OR=1.353 95%CI 1.352-1.354), >65 years of age (OR=1.369 95%CI 1.368-1.371), African American (OR=1.892 95%CI 1.889-1.894), not educated beyond high school (OR=1.400 955CI 1.3991.402), uninsured (OR=1.308 95%CI 1.3-6-1.310), without a HCP (OR=1.216 95%CI 1.215-1.218), and living in a household with

Background: Patients with high blood pressure (BP) visit a physician on average 4 times per year, though fewer than half achieve BP control. Practical, effective, and sustainable models are needed to improve BP management. Aims: Hyperlink is a clinic-randomized trial testing an intervention that combines home BP telemonitoring with pharmacist case management in patients with uncontrolled hypertension. Methods: We enrolled 450 patients with uncontrolled BP from 16 primary care clinics. Eight clinics (222 patients) were randomized to usual care and 8 clinics (228 patients) to intervention. Intervention patients received home telemonitors that transmit BP data to a secure database. Pharmacists consult with patients by phone and adjust antihypertensive therapy based on home BP data. The intervention lasts 12 months with follow-up to 18 months to observe durability. The primary outcome is BP control at 6 and 12 months, defined as BP ≤140/90 mm Hg (or ≤130/80 mm Hg in patients with chronic kidney disease or diabetes). Data on demographics, medication use and adherence, and satisfaction with care were also gathered. Here we report 6-month BP outcomes. General and generalized linear mixed models are used to accommodate the cluster-randomization. Results: Enrollees were 45% female, 83% white, and 13% black, with mean age of 61 years. Mean BP at baseline was 148/85 mm Hg in both treatment groups. Of the 403 attending the 6-month visit (197 usual care, 206 intervention), 45.2% in usual care and 71.8% in intervention achieved BP control (p Conclusions: Home telemonitoring with pharmacist case management was effective at reducing BP for hypertensive patients over 6 months. This intervention may be cost-effective for managing hypertensive patients with uncontrolled BP, especially if results are sustained during the maintenance and post-intervention phases of follow-up.

Background This study describes contraceptive understanding, sources of information and consequences of contraceptive misunderstandings among urban, young adults. Study Design We used qualitative data from 16 focus groups and 53 interviews with Puerto Rican and African American men and women aged 18–25 years from Philadelphia and Hartford. We categorized and compared assertions made about all contraceptive methods' side effects, effectiveness and use using an iterative process. Results Participants considered contraceptive use worthwhile but felt that it carried risks of problematic side effects and contraceptive failure, with variation among methods. Men knew most about condoms and withdrawal and trusted both more than women. Personal or second-hand experience was the dominant source of information on contraceptive understanding. Misunderstandings about contraception affected their relationships and risk of unintended pregnancy. Conclusion Contraceptive understanding is a powerful determinant of contraceptive use and limits the options perceived by young adults to prevent pregnancy. Research is needed to strengthen contraceptive counseling and outreach in ways that better leverage peer influence.

CONTEXT: Heterosexual anal sex is not uncommon in the United States, and it poses risk for STDs. However, who engages in it and why are not well understood, particularly among young adults. METHODS: In 2006–2008, data on sexual health–related topics were collected in surveys (483 respondents) and qualitative interviews (70 participants) with black and Puerto Rican 18–25-year-olds in Hartford and Philadelphia. Bivariate and multivariate analyses of survey data assessed predictors of anal sex with the most recent serious heterosexual partner. Interview transcripts were analyzed for anal sex experiences and reasons for and against engaging in this behavior. RESULTS: Some 34% of survey respondents had had anal sex; this behavior was more common with serious partners than with casual partners (22% vs. 8%). Black respondents were less likely than Puerto Ricans to report anal sex (odds ratio, 0.3); women were more likely to do so than were men (2.9). In the qualitative cohort, perceptions of anal sex as painful and unappealing were the predominant reasons for not having anal sex, whereas sexual pleasure and, in serious relationships, intimacy were the main reasons for engaging in it. Condom use during anal sex was rare and was motivated by STD or hygiene concerns. CONCLUSIONS: Heterosexual anal sex is not an infrequent behavior and should be considered in a broad sexual health context, not simply as an indicator of STD risk. Health providers should address it openly and, when appropriate, as a positive sexual and emotional experience.

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.

Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07).Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.clinicaltrials.gov Identifier: NCT00781365.

Background/Aims Guidelines for blood pressure (BP) treatment thresholds and goals have been derived from measurements obtained in research clinics (RC), but few studies have compared BP measurements obtained in RC and routine primary care practice (PCP) settings, where decisions about BP treatment occur.