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RecruitingNCT07208669

Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
4 (estimated)
Sponsor
Elizabeth Pfoh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Approximately 50-72% of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension. Hypertension increases the risk of devastating cardiovascular outcomes, such as strokes, heart attacks, and heart failure. Three-quarters of admitted patients experience at least one elevated blood pressure (BP) (\>140/90) during hospitalization. While BP is usually elevated for benign reasons, including pain and anxiety, acutely elevated BP can cause end-organ damage. Currently, no guidelines exist for managing asymptomatically elevated BP in the inpatient setting. There is growing observational evidence that antihypertensive medication intensification for asymptomatically elevated BP can result in adverse outcomes, such as increased readmission. Since observational studies are biased, a large-scale clinical trial is needed to identify whether to treat asymptomatically elevated BPs in the hospital. Yet, it would be unethical and costly to randomize individual patients to receive antihypertensive medication intensification. To overcome these obstacles, this study uses hospital-unit-level intervention, ACT-BP. ACT-BP removes standing orders to call physicians about elevated BPs (which encourages treatment due to social desirability bias), provides education on the potential harm of treating asymptomatically elevated BPs, and suggests alternative procedures (e.g., monitoring BP more frequently). At the end of the study, three specific pieces of knowledge needed to conduct a larger, adequately powered randomized clinical trial will be obtained. First, how much does ACT-BP reduce antihypertensive medication intensification? Second, what refinements will improve its effectiveness? Third, what is the rate of the composite outcome in the intervention and control units?

Conditions

Interventions

TypeNameDescription
OTHERACT-BP InterventionIn 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.

Timeline

Start date
2025-11-11
Primary completion
2026-12-31
Completion
2027-07-31
First posted
2025-10-06
Last updated
2026-01-08

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07208669. Inclusion in this directory is not an endorsement.