NCT07232017

Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,520 (estimated)
• Sponsor: Anita Misra-Hebert · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Detailed description

Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections. Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months) * Quantitative assessment of practice variation in HTN control. * Qualitative assessment of practice barriers and facilitators to HTN management. * Creation of a clinical decision support tool for program referral. * Creation of project-specific patient and employee Advisory Panel. * Pharmacist and advanced practice provider (APP) training for delivery of the program. * Practice facilitation training with the Cleveland Clinic continuous improvement team. * Community Health Worker/Primary Care Navigator Training for Patient Outreach. * Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months) * Stepped wedge rollout of intensive HTN management program. * Implementation of the clinical decision support tool at implementation sites. * Community Health Worker/Primary Care Navigator outreach to patients. * Delivery of Presentations at primary care staff meetings. * Practice Facilitation at Implementation Sites. * Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility. * Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility. * Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months) * Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase. * Capture practice-level adaptations with comparison to the active implementation phase. * Complete final data collection and analyses.

Conditions

• Hypertension (HTN)

Interventions

Type	Name	Description
OTHER	IN-HOME BP	A team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Timeline

• Start date: 2026-01-06
• Primary completion: 2029-04-01
• Completion: 2029-07-01
• First posted: 2025-11-18
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States