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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Elizabeth Pfoh
Study ID
NCT07208669
Status
Recruiting

Conditions

  • Blood Pressure Control

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACT-BP Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 11, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
4 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44195
Emma J Wensink
216-442-5341
Elizabeth Pfoh (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic HillcrestMayfield HeightsOhio44124
Emma J Wensink
216-442-5341
Elizabeth Pfoh (PRINCIPAL_INVESTIGATOR)

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