Hypertension
Conditions
Keywords
Hypertension, Perioperative Care
Brief summary
This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control.
Detailed description
A convenience sample of presurgical patients seen in a preadmission testing clinic were enrolled and sent home with a home blood pressure monitor that stored up to 50 readings. Participants were asked to return the BP cuff on the day of their surgery.
Interventions
None listed
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory patients \>= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.
Exclusion criteria
* Inability or unwillingness to independently operate a home blood pressure monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of Blood Pressure Referral Threshold | Subjects followed for approximately 1 year | The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure \>135/85mmHg will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures. | 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. |
| Preidentified Subgroups | 1 year | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis. |
| Patient Perspectives | 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. |
| Patient Adherence | 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. |
| Preidentified Subgroup Analysis | 1 year | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Included Participants |
|---|---|
| Age, Continuous | 64.42 years STANDARD_DEVIATION 12.8 |
| DBP | 88.39 mmHg STANDARD_DEVIATION 9.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) White | 149 Participants |
| SBP | 156.26 mmHg STANDARD_DEVIATION 14.11 |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
Performance of Blood Pressure Referral Threshold
The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure \>135/85mmHg will be calculated.
Time frame: Subjects followed for approximately 1 year
Population: Of the 200 participants, 188 returned Home BP Cuffs with valid BP data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Included Participants | Performance of Blood Pressure Referral Threshold | .841 proportion |
Secondary
Patient Adherence
The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
Time frame: 60 days
Secondary
Patient Perspectives
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.
Time frame: 60 days
Secondary
Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.
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.
Time frame: Approximately 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Included Participants | Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures. | .158 Cohen's Kappa coefficient |
Secondary
Preidentified Subgroup Analysis
The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.
Time frame: 1 year
Secondary
Preidentified Subgroups
The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.
Time frame: 1 year