Recruiting

ACT-BP

Sponsor:

Elizabeth Pfoh

Code:

NCT07208669

Conditions

Blood Pressure Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACT-BP Intervention

Study Details

Brief summary:

The vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. There are no guidelines for managing asymptomatically elevated BPs in the inpatient setting, and growing observational evidence suggests that antihypertensive medication intensification increases harm. The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is scientifically necessary for designing a cluster-randomized clinical trial that identifies the impact of intensification after experiencing an asymptomatically elevated BP on patient outcomes.

Conditions

Blood Pressure Control

Study ID

NCT07208669

Start date

Nov 11, 2025

Status verified date

Jan, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

The ACT-BP protocol will be implemented in the intervention units. First, the study team will implement an order on the unit that prompts the nurses to follow the ACT-BP algorithm when a patient has an asymptomatic elevated BP between 160mmHg and 199mmHg. This protocol does not apply to patients who are experiencing hypertensive emergencies or cardiac symptoms. To increase adherence to the ACT-BP protocol, knowledge related to treating the potential underlying causes of an asymptomatically elevated BP and the current state of the evidence will be shared through posters, information sheets and knowledge sessions.

At the the intervention hospital, the study team will provide caregivers (including physicians) with knowledge related to the state of the evidence for treating asymptomatically elevated BPs through emails, information sheets and one-pagers.

no intervention: Control Arm

In the control units, care will continue as usual.

At the the control hospital, caregivers (including physicians) will receive knowledge related to the state of the evidence for treating asymptomatically elevated BPs through an email.

Interventions

ACT-BP Intervention

In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.

Primary outcome measure

  • Primary Outcome [ Time Frame: From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months. ]

Central Contacts and Locations

Central contacts

Elizabeth Pfoh, PhD, MPH

12162963034pfohe@ccf.org

Locations

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emma J Wensink

216-442-5341wensine2@ccf.org

Principal Investigator:

Elizabeth Pfoh

Cleveland Clinic Hillcrest

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Emma J Wensink

216-442-5341wensine2@ccf.org

Principal Investigator:

Elizabeth Pfoh

More Information

Sponsor

Elizabeth Pfoh

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • hypertension
  • inpatient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elizabeth Pfoh on 2026-01-08.