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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL116641 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Subjects followed for approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory surgical patients >= 21 years of age presenting for preadmission testing to a tertiary care hospital and who demonstrate elevated clinic blood pressures greater than or equal to 130/85mmHg.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Schonberger, MD/MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital PreAdmission Testing Clinic | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26214552 | Background | Schonberger RB, Dai F, Brandt CA, Burg MM. Balancing Model Performance and Simplicity to Predict Postoperative Primary Care Blood Pressure Elevation. Anesth Analg. 2015 Sep;121(3):632-641. doi: 10.1213/ANE.0000000000000860. | |
| 22075017 | Background | Schonberger RB, Burg MM, Holt N, Lukens CL, Dai F, Brandt C. The relationship between preoperative and primary care blood pressure among veterans presenting from home for surgery: is there evidence for anesthesiologist-initiated blood pressure referral? Anesth Analg. 2012 Jan;114(1):205-14. doi: 10.1213/ANE.0b013e318239c4c1. Epub 2011 Nov 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 200 participants, 188 returned Home BP Cuffs with valid BP data. | Posted | Number | 95% Confidence Interval | proportion | Subjects followed for approximately 1 year |
|
From time of enrollment until participant returned for surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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94% of participants returned Home BP cuffs with at least one valid reading.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Schonberger, PI | Yale School of Medicine | 203-785-2802 | robert.schonberger@yale.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Preidentified Subgroups | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis. | 1 year |
| 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. | 60 days |
| 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. | 60 days |
| Preidentified Subgroup Analysis | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis. | 1 year |
| 24905036 | Background | Schonberger RB. Ideal blood pressure management and our specialty. J Neurosurg Anesthesiol. 2014 Jul;26(3):270-1. doi: 10.1097/ANA.0000000000000012. No abstract available. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| SBP | Mean | Standard Deviation | mmHg |
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| DBP | Mean | Standard Deviation | mmHg |
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| Units |
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| Participants |
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| 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. | Posted | Number | 95% Confidence Interval | Cohen's Kappa coefficient | Approximately 60 days |
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| Secondary | Preidentified Subgroups | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis. | Not Posted | 1 year | Participants |
| 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. | Not Posted | 60 days | Participants |
| 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. | Not Posted | 60 days | Participants |
| Secondary | Preidentified Subgroup Analysis | The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis. | Not Posted | 1 year | Participants |
| 0 |
| 200 |
| 0 |
| 200 |
| 0 |
| 200 |
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