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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElizabeth Pfoh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients less than 18

Patients experiencing hypertensive emergencies or cardiac symptoms

Patients with active cardiovascular events, such as

Stroke

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACT-BP Intervention

    Other 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.

Treatment groups

4 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary Outcome

The number of new orders for antihypertensive medications or increased doses of an antihypertensive medication for patients who experience an elevated systolic BP (≥160 mmHg and ≤199 mmHg).

Time frame
From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elizabeth Pfoh

Lead sponsor

The Cleveland Clinic

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator