Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

Blood Pressure Clinical Trial

Official title:

Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634813
• Other study ID #: 2000023093
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: April 17, 2021

Study information

• Verified date: November 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.

Description:

The intervention and control groups will be defined by, 1) preoperative home blood pressure monitoring with a detailed report sent to the patient, and 2) usual standard of care including a suggestion during the pre-operative clinic appointment to follow up with Primary Care. Both groups will receive a brief questionnaire about their blood pressure treatment and medication adherence. We will examine the rate of primary care follow-up and changes in hypertension treatment at 60 days post-operative, through a telephone call. This information, along with information regarding patient acceptance of the intervention will be used to inform the design of a future clinical trial powered to outcomes, including follow-up visits and blood pressure management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 17, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• We propose to recruit patients who present for ambulatory surgery, aged >18 years, with a preoperative blood pressure > 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.

Exclusion Criteria:

• Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
• Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• High Blood Pressure Monitor
High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)

Procedure:
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital PreAdmission Testing Clinic	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients Demonstrating HBPM Elevation.	The proportion of patients demonstrating HBPM elevation was measured. Specific cut-offs for the interpretation of home blood pressure are controversial. The mean home blood pressure threshold was > 135/85 mmHg as indicating hypertension, in-line with recommendations from the American Heart Association.	1 year
Primary	Patients Reporting Primary Care Follow-up	For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days	60 days
Primary	Patients Reporting New/Adjusted Hypertension Treatment.	For the primary analysis, we will estimate the proportion reporting new/adjusted hypertension treatment within 60 days. The count of participants is the number of patients for whom it was determined that they had new or adjusted hypertension treatment.	60 days
Secondary	Patient Acceptance/Satisfaction With Blood Pressure Care	Patient Acceptance/Satisfaction With Blood Pressure Care. A questionnaire was provided to all participants, these data were not intended to be compared between treatment arms. The count of participants is the number of participants that reported they were moderately to very satisfied with their care.	60 days