Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

Not Applicable

Completed

• Conditions: Blood Pressure

• Registration Number: NCT03634813
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2018-08-31
• Primary Completion: 2020-05-01
• Study Completion: 2021-04-17
• Results First Submitted: 2021-04-30
• Results First Submitted QC: 2021-04-30
• Results First Posted: 2021-05-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patients Reporting Primary Care Follow-up	60 days	For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days
Patients Reporting New/Adjusted Hypertension Treatment.	60 days	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.

Secondary Outcome Measures

Name	Time	Method
Patient Acceptance/Satisfaction With Blood Pressure Care	60 days	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.

Trial Locations

Locations (1)

Yale-New Haven Hospital PreAdmission Testing Clinic; 🇺🇸 New Haven, Connecticut, United States