Protocol of a patient randomized clinical trial to improve medication adherence in primary care.

BACKGROUND: Enhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. METHODS: The original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18-74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months. Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. CONCLUSION: This manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges.

Reach in a pragmatic hypertension trial: A critical RE-AIM component.

BACKGROUND: Hypertension control is falling in the US yet efficacious interventions exist. Poor patient reach has limited the ability of pragmatic trials to demonstrate effectiveness. This paper uses quantitative and qualitative data to understand factors influencing reach in Hyperlink 3, a pragmatic hypertension trial testing an efficacious pharmacist-led Telehealth Care intervention in comparison to a physician-led Clinic-based Care intervention. Referrals to both interventions were ordered by physicians. METHODS: A sequential-explanatory mixed methods approach was used to understand barriers and facilitators to reach. Reach was assessed quantitatively using EHR data, defined as the proportion of eligible patients attending intended follow-up hypertension care and qualitatively, via semi-structured interviews with patients who were and were not reached. Quantitative data were analyzed using descriptive and inferential statistics. Qualitative data were analyzed via combined deductive and inductive content analysis. RESULTS: Of those eligible, 27% of Clinic-based (n = 532/1945) and 21% of Telehealth patients (n = 385/1849) were reached. In both arms, the largest drop was between physician-signed orders and patients attending initial intended follow-up care. Qualitative analyses uncovered patient barriers related to motivation, capability, and opportunity to attend follow-up care. CONCLUSIONS: Although the proportion of eligible patients with signed orders was high in both arms, the proportion ultimately reached was lower. Patients described barriers related to the influence of one's own personal beliefs or priorities, decision making processes, logistics, and patient perceptions on physician involvement on reach. Addressing these barriers in the design of pragmatic interventions is critical for future effectiveness. TRIAL REGISTRATION: NCT02996565.

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.

Development and Validation of a Patient Satisfaction Survey for Comprehensive Medication Management.

BACKGROUND: Comprehensive medication management (CMM) services are a relatively new standard for clinical practice. A patient satisfaction tool for pharmacists providing comparable pharmacy services is essential for measuring quality and sustainability. OBJECTIVE: To develop a psychometrically valid questionnaire for measuring patient satisfaction for CMM services. METHODS: A patient satisfaction survey tool was developed through a multiphase development process. Validation studies were conducted across 2 urban ambulatory care health system settings providing CMM services. The survey consisted of 10 items related to 3 domains: medication-related needs, pharmacist-patient engagement, and overall satisfaction. Using a 4-point scale, the surveys were mailed, collected, and analyzed for descriptive statistics, internal consistency, and factorial composition. RESULTS: Total surveys returned for analysis numbered 195, with an overall survey response rate of 19.2%. Factor analysis and item analysis identified 1 factor of pharmacists' patient care services. The factor was named "patient satisfaction." CONCLUSIONS: The instrument that was developed provided 1 factor of CMM services. This brief patient satisfaction tool appears to be reliable and valid and may serve other CMM providers to assess 1 measure of quality assurance upon further evaluation.