Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: High Blood Pressure Monitor; Procedure: Usual Care

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale-New Haven Hospital PreAdmission Testing Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: High Blood Pressure Monitor; High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
Active Comparator: 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.	Procedure: Usual Care; Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Robert Schonberger, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): April 17, 2021

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2000023093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes