Trial Outcomes & Findings for Perioperative Blood Pressures and Chronic Hypertension (NCT NCT02136810)

Last Updated: 2023-06-05

Results Overview

The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure \>135/85mmHg will be calculated.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

Subjects followed for approximately 1 year

Results posted on

2023-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Included Participants A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Blood Pressures and Chronic Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Included Participants n=200 Participants A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
Age, Continuous	64.42 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
SBP	156.26 mmHg STANDARD_DEVIATION 14.11 • n=5 Participants
DBP	88.39 mmHg STANDARD_DEVIATION 9.81 • n=5 Participants

PRIMARY outcome

Timeframe: Subjects followed for approximately 1 year

Population: Of the 200 participants, 188 returned Home BP Cuffs with valid BP data.

The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure \>135/85mmHg will be calculated.

Outcome measures

Outcome measures
Measure	Included Participants n=188 Participants A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
Performance of Blood Pressure Referral Threshold	.841 proportion Interval 0.78 to 0.89

SECONDARY outcome

Timeframe: Approximately 60 days

In secondary analyses, the agreement between patients' self-reported blood pressure control (binary outcome) and home blood pressure monitor-determined blood pressure status (binary outcome) will we assessed via Cohen's kappa and raw indices of agreement.

Outcome measures

Outcome measures
Measure	Included Participants n=188 Participants A convenience sample of 200 ambulatory patients scheduled for surgery was recruited during their preadmission visit at Yale-New Haven Hospital between November 2015 and December 2016. Inclusion criteria were age ≥21 years and a screening BP ≥ 130/85 mm Hg.
Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.	.158 Cohen's Kappa coefficient Interval 0.062 to 0.254

SECONDARY outcome

Timeframe: 1 year

The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days

The possible association of self-reported availability of primary care (5 point LIKERT scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days

The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.

Outcome measures

Outcome data not reported

Adverse Events

Included Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Schonberger, PI

Yale School of Medicine

Phone: 203-785-2802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place