Treating elevated blood pressure during hospital stays to see if it changes outcomes

Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes: the ACT-BP Pilot

We are testing whether changing how hospitals respond to briefly high blood pressure in adults on general medical units reduces unnecessary increases in blood-pressure medicines and improves patient outcomes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 4 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 2 sites (Cleveland, Ohio and 1 other locations)
• Trial ID: NCT07208669 on ClinicalTrials.gov

What this trial studies

This unit-level intervention called ACT-BP removes standing orders that prompt automatic physician notification for elevated blood pressures, provides education about potential harms of treating asymptomatic inpatient BP elevations, and suggests alternatives such as more frequent monitoring and nonpharmacologic measures. The intervention is implemented at the hospital-unit level on general medical wards and outcomes include the rate of antihypertensive medication intensification and downstream patient events. The study is designed to generate the key feasibility and outcome data needed to plan a larger cluster-randomized trial that will determine whether inpatient intensification affects readmissions and adverse events. Enrollment excludes patients with hypertensive emergencies, active cardiovascular events, dialysis-dependent renal failure, pregnancy, very short or very long stays, ICU transfers, or systolic BP that remains below 160 mmHg during hospitalization.

Who should consider this trial

Good fit: Adults with hypertension admitted to non-ICU general medical units who have asymptomatic elevated blood pressure readings and do not meet exclusion criteria are the intended candidates.

Not a fit: Patients with hypertensive emergencies or active cardiovascular events, those on dialysis or with end-stage renal disease, pregnant or postpartum women, very short or prolonged hospital stays, ICU transfers, or those whose systolic BP stays below 160 mmHg are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the approach could reduce unnecessary increases in blood-pressure medications and lower related harms such as readmissions and adverse events.

How similar studies have performed: Observational studies have suggested potential harm from inpatient antihypertensive medication intensification, but randomized evidence is lacking and unit-level interventions like ACT-BP are relatively novel.

Eligibility criteria

Inclusion Criteria:

* At the unit level: Medical units that do not typically care for patients requiring step-down care.

Exclusion Criteria:

1. Patients less than 18
2. Patients experiencing hypertensive emergencies or cardiac symptoms
3. Patients with active cardiovascular events, such as

   * Stroke
   * Non-ST-elevation
   * Myocardial infarction
   * End-stage renal disease
   * Patients on dialysis
   * Those with acute decompensated heart failure

3\. Patients on the unit for more than 10 days

4\. Patients transferred in after being in the intensive care unit (ICU)

5\. Pregnant and post-partum women

6\. Patients discharged within 24 hours of admission

7\. Patients whose systolic BP remains below 160 mmHg during hospitalization.

Where this trial is running

Cleveland, Ohio and 1 other locations

• Cleveland Clinic Main Campus — Cleveland, Ohio, United States (RECRUITING)
• Cleveland Clinic Hillcrest — Mayfield Heights, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Elizabeth Pfoh, PhD, MPH — The Cleveland Clinic
• Study coordinator: Elizabeth Pfoh, PhD, MPH

Conditions: Blood Pressure Control, hypertension, inpatient