Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

NCT ID: NCT03634813

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2021-04-17

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

High Blood Pressure Monitoring and Counseling

Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.

Group Type: EXPERIMENTAL

High Blood Pressure Monitor

Intervention Type: DEVICE

High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)

Usual Care

The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: PROCEDURE

Usual Care

Interventions

High Blood Pressure Monitor

High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)

Intervention Type: DEVICE

Usual Care

Usual Care

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Schonberger, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital PreAdmission Testing Clinic

New Haven, Connecticut, United States

Countries

United States

References

Diaz SI, Yan L, Dai F, Zhou B, Burg MM, Schonberger RB. Feasibility of a randomized hypertension screening initiative in the perioperative setting. Perioper Med (Lond). 2021 Nov 22;10(1):39. doi: 10.1186/s13741-021-00210-7.

Reference Type: DERIVED

PMID: 34802471 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000023093

Identifier Type: -

Identifier Source: org_study_id