Implementation outcomes associated with a value-based care model of comprehensive medication management in community pharmacies.

OBJECTIVE: Although the delivery of comprehensive medication management (CMM) in community pharmacies has been shown to improve health outcomes, inconsistent adoption hinders the benefit patients receive. Our objective was to examine the implementation of a novel value-based care model and the impact of educational and coaching support for pharmacists on patient access to CMM. The underlying care model provides a payment for CMM services combined with incentives to document and improve clinical outcomes and patient engagement. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: In addition to fee-for-service payments, performance-based incentives were provided to 12 participating pharmacy organizations to promote pharmacist documentation of clinical values (blood pressure and tobacco status for patients with vascular disease and additionally hemoglobin A1c [HbA1C] for patients with diabetes). To promote patient engagement, pharmacies that engaged a higher proportion of attributed patients received additional incentives. OUTCOME MEASURES: Implementation outcomes included penetration (the proportion of eligible patients who received CMM), adoption (variation in penetration across organizations), and fidelity (documentation of all required clinical values). Comparisons were made using t-tests and chi-square testing. RESULTS: Among 1240 eligible patients, 478 (35.8%) had documentation of any service by a participating pharmacist during a one-year implementation period. Using diabetes as an example, documentation was consistently highest for tobacco status (38.1%), followed by blood pressure (29.7%), and HbA1C (38.1%). CMM recipients on average were older, used more medication, and were more likely to have at least one comorbid condition than non-recipients. 41.8% of patients with vascular disease had documentation of both blood pressure and tobacco status while 24.4% of patients with diabetes had blood pressure, tobacco, and HbA1C documentation. CONCLUSIONS: Improving pharmacist access to a patient's medical records could help improve access to CMM services for patients under value-based care models that rely on patient targeting and clinical measurements.

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.

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.

Seeing the Forest Through the Trees: Improving Adherence Alone Will Not Optimize Medication Use.

Medication adherence is a problem that has received widespread attention in the medical literature and health policy circles. With the increased emphasis on recognizing and rewarding quality in the U.S. health care system, medication adherence measures are increasingly being adopted to assess quality of medication use. However, when adherence is discussed in the literature or evaluated via quality measures, there is rarely any dialogue surrounding adherence in the context of patient-centered issues such as clinical status, individualized medication needs, or personal expectations and social situation. When nonadherence is identified via a comprehensive assessment of all of a patient's medication-related issues, it typically is recognized as only the third most frequent type of medication-related problem. Issues such as requiring a medication that has not been prescribed or receiving a medication prescribed at a dose too low to achieve the intended clinical goal are more frequently experienced. Furthermore, if a patient is nonadherent to a medication because of adverse effects or if the medication prescribed is not appropriate considering the patient's individual clinical situation, promoting adherence can create unintended harm. Therefore, achieving medication adherence as typically evaluated via existing quality metrics such as proportion of days covered is only valid if the medication is first deemed to be indicated, effective, and safe for the patient. Medications are the most common medical intervention for chronic illnesses. As a result, success in achieving the Triple Aim of health care is highly dependent on optimizing medication use. When quality measures for medication use narrowly focus on measuring adherence, the resulting programs of payers and providers will likely ignore the most frequent types of medication problems that prevent improved health, create unnecessary costs, and could negatively impact patients' experience with the health care system. Strong leadership and advocacy on the part of agencies in the position to influence the quality measurement landscape in the U.S. health care system will be critical to achieve widespread awareness of medication nonadherence in the context of the full scope of medication-related problems in health care. DISCLOSURES: No outside funding supported this research. Brummel provides consulting services to other health systems; has received grants from Sanofi and speaking fees from AMCP, APhA, and ASHP; and is on the faculty at the University of Minnesota and employed by Fairview Pharmacy Services. Ekstrand provides consulting services for Alliance for Integrated Medication Management and has received speaking fees from International Diabetes Center and MN Alliance of Physician Assistants. The authors report no other conflict of interest, potential or otherwise. Study concept and design were contributed primarily by Sorensen, Brummel, and Rehrauer, along with the other authors. Rehrauer, Brummel, and Ekstrand collected the data, which were interpreted by Sorensen, Brummel, Rehrauer, and Ekstrand. Pestka and Sorensen wrote and revised the manuscript, with assistance from the other authors.