Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic (IN-HOME BP)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension (HTN)
• Intervention / Treatment: Other: IN-HOME BP

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.

• Study Type: Observational
• Enrollment (Estimated): 1520

Contacts and Locations

• Study Contact: Name: Anita Misra-Hebert, MD, MPH, FACP; Phone Number: 216-445-8542; Email: MISRAA@ccf.org
• Study Contact Backup: Name: Christopher Babuich, MD; Phone Number: 440 204-7400; Email: babiucc@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Per inclusion criteria and that the patient has at least 2 encounters with a HTN diagnosis within the past 24 months; had an encounter within the past 12 months at their PCPs assigned location; had a documented systolic blood pressure of >150 or diastolic blood pressure of >95 at the most recent encounter at the primary care location, and a previous encounter within the health system within the past 24-month qualifying time frame with a documented systolic blood pressure of >150 or diastolic blood pressure of >95.

Description

Inclusion Criteria:

• Hypertension diagnosis, aged 18-85 years old
• Uncontrolled blood pressure, defined as a blood pressure reading of > 150/95

Exclusion Criteria:

• pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure Change	The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period.	Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure Change	Change in the patient's diastolic blood pressure from baseline as measured in mmHg.	The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.
Reach (Actual): Patients Offered, Initiated, Completed	Number of patients who were offered, who initiated, and completed the intensive HTN intervention program. Measured by total number at sorted by each: offered, initiated, completed.	Measured every 3 months for up to 33 months.
Effectiveness: Equity in Outcomes (Race)	Blood pressure change stratified by demographic factors, specifically race. Measured as percentage of black, white, and other.	Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Ethnicity)	Blood pressure change stratified by demographic factors, specifically ethnicity. Measured by percentage of Hispanic and non-Hispanic	Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Gender)	Blood pressure change stratified by demographic factors, specifically gender. Measured by percentage of male and female.	Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Age)	Blood pressure change stratified by demographic factors, specifically age group. Measured in years.	Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Insurance)	Blood pressure change stratified by demographic factors, specifically insurance. Measured in number of insurance: Medicare, Medicaid, Commercial, Self-pay.	Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication change	Change from baseline medication regimen (medication class and dosage).	Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication Adherence	Pharmacy Fill Data	Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Cardiovascular outcomes	Sustained blood pressure control resulting in decreased cardiovascular risk: reported myocardial infarction, acute coronary syndrome, stroke, heart failure, arrhythmia, and death.	Baseline, and every 6 months through maintenance: for up to 33 months.
Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR).	Assessing acute renal failure by change in glomerular filtration rate (GFR) as measured in milliliters/minute/1.73 meters squared.	Every 6 months through maintenance: for up to 33 months.
Effectiveness: PROMIS-10 Survey	See improvement of patient report outcomes captured at pre-visit PROMIS-10 survey(12) administration as part of routine clinical care. As measured by assessing scores over time.	Baseline at intake visit then at 12 months: up to 24-months.
Effectiveness: Adverse Effects	Patient reported adverse effects at follow-up visits during intervention. Measured as number of effects reported by patient.	Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Implementation: Provider views of the Acceptability, Appropriateness, and Feasibility survey	Captured through surveys, provider views of Acceptability, Appropriateness, Feasibility (13). Providers views of intervention may impact adoption of intervention for patients. Measured by change in item scored over time.	Every 6 months starting throughout active implementation and maintenance: for up to 33 months.
Primary Care Provider Adoption	Number of providers in each practice group referring to the Intensive HTN program will be measured by the number of referrals attributed to practice group.	Every 3 months during intervention period: for up to 24 months
Pharmacist Adoption	Number of patients in the program attributed to the trained pharmacy providers eligible to deliver the program.	Every 3 months during intervention period: for up to 24 months.
Advanced Practice Provider Adoption	Number of patients in the program attributed to the trained Advanced Practice Providers (APP) eligible to deliver the program.	Every 3 months during intervention period: for up to 24 months.
Formal Qualitative Assessment of context of high proportion of HTN control and low proportion of HTN control practices: Pre-Implementation	To understand barriers and facilitators to achieving HTN control; Semi-structured interviews with non-patient (employee) key stakeholders at practices with high/low proportion of HTN control; Direct field observations of high-low referral practice sites Qualitative methodologists will analyze the qualitative data (transcripts and descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes.	Pre-Implementation: up to 12 months.
Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels	To examine anticipated barriers and facilitators to implementation and to assess ongoing implementation activities. Qualitative methodologists will analyze the qualitative data (fieldnotes) will be coded to reflect key domains of interest and emergent themes.	Quarterly meetings throughout pre- and active implementation: up to 36 months.
Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low proportion of HTN Control	Inviting a sample of patients receiving the intervention at high and low proportion of HTN control practices to participate in interviews to assess perceptions of acceptability of the intensive HTN management program. Qualitative methodologists will analyze the qualitative data (transcripts) will be coded to reflect key domains of interest and emergent themes.	Baseline, 6 months, 12 months during active implementation: up to 24 months.
Formal Qualitative Assessment: Periodic Reflections with agents of implementation	Periodic reflections conducted with a subgroup of pool of primary care providers, pharmacists, and APPs across practice locations to understand barriers and facilitators to achieving hypertension control. Qualitative methodologists will analyze the qualitative data (descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes.	Monthly or bimonthly throughout active implementation and maintenance: for up to 33 months.
Outcome measure type: Effectiveness (Hospitalizations / Emergency Department Visits)	Hospitalizations and Emergency Department Visits: number of acute care hospitalizations, number of emergency department visits. Determining association between intensive HTN management and acute care utilization.	Every 6 months: up to 33 months.
Outcome Measure Type: Effectiveness (Outpatient Visits)	Outpatient visits other than for the intensive HTN management program. Number of outpatient visits (in-clinic or virtual, primary care and specialty). To determine association between intensive HTN management and acute care utilization.	Every 6 months: up to 33 months.

Collaborators and Investigators

• Sponsor: Anita Misra-Hebert
• Collaborators: Patient-Centered Outcomes Research Institute; The Cleveland Clinic

Publications and helpful links

General Publications

• Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.
• Cuttaree P, Edlund G, Eriksson M, Granberg P, Lager O, Lonberg E, Sjoberg P, Widell K. [Should sick children be kept in bed?]. Lakartidningen. 1971 Mar 24;68(13):1485-8. No abstract available. Swedish.
• Murakami K, Minoshima S, Uno K, Arimizu N, Kobayashi M, Fujita M, Okamoto S, Ikehira H, Fukuda H, Tateno Y. [Imaging of malignant melanoma with In-111-labeled monoclonal antibody (ZME-018) and Ga-67 scintigraphy]. Kaku Igaku. 1989 Jan;26(1):113-9. No abstract available. Japanese.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; pharmacist; home blood pressure; uncontrolled blood pressure; advanced practice provider
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 25-792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data used for this study includes human research participant data that are sensitive and cannot be publicly shared due to legal and ethical restrictions by the Cleveland Clinic regulatory bodies, including the institutional review board and legal counsel. We will make our data sets available on request, under appropriate data use agreements with the specific parties interested in academic collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No