Clinical Trial Radar

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.

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.