Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic

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.

Change in the patient's diastolic blood pressure from baseline as measured in mmHg.

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.

Blood pressure change stratified by demographic factors, specifically race. Measured as percentage of black, white, and other.

Blood pressure change stratified by demographic factors, specifically ethnicity. Measured by percentage of Hispanic and non-Hispanic

Blood pressure change stratified by demographic factors, specifically gender. Measured by percentage of male and female.

Blood pressure change stratified by demographic factors, specifically age group. Measured in years.

Blood pressure change stratified by demographic factors, specifically insurance. Measured in number of insurance: Medicare, Medicaid, Commercial, Self-pay.

Change from baseline medication regimen (medication class and dosage).

Pharmacy Fill Data

Sustained blood pressure control resulting in decreased cardiovascular risk: reported myocardial infarction, acute coronary syndrome, stroke, heart failure, arrhythmia, and death.

Assessing acute renal failure by change in glomerular filtration rate (GFR) as measured in milliliters/minute/1.73 meters squared.

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.

Patient reported adverse effects at follow-up visits during intervention. Measured as number of effects reported by patient.

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.

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.

Number of patients in the program attributed to the trained pharmacy providers eligible to deliver the program.

Number of patients in the program attributed to the trained Advanced Practice Providers (APP) eligible to deliver the program.

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.

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.

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.

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.

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.

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.