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.

A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work?

BACKGROUND: 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. OBJECTIVE: 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. DESIGN: 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). PARTICIPANTS: Four hundred three of 450 trial participants completing the 6-month follow-up visit were included. INTERVENTIONS: 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. MAIN MEASURES: 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. KEY RESULTS: 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. CONCLUSIONS: 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.

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.

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.

Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial.

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.

Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial.

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.

Patient characteristics associated with greater blood pressure control in a randomized trial of home blood pressure telemonitoring and pharmacist management.

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.