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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Blood Pressure Monitoring and Counseling | Experimental | 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. |
|
| Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Blood Pressure Monitor | Device | High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL) |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Schonberger, MD | 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 |
|---|---|---|---|
| 34802471 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL) |
| FG001 | 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. Usual Care: Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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 | Posted | Count of Participants | Participants | 60 days |
|
60 days
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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 | 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. High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert B. Schonberger, Director of Clinical Scientist Track Program | Yale School of Medicine | 203-785-3941 | robert.schonberger@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2020 | Jun 3, 2021 | Prot_SAP_001.pdf |
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2 cohort parallel
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| Usual Care | Procedure | Usual Care |
|
| BG001 | 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 National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure". 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. Usual Care: Usual Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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. Usual Care: Usual Care |
|
|
| Primary | 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. | The overall number of participants analyzed were those successfully reached or whose ehr information enabled determination of the outcome in each arm. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | 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. | 61 total patients that completed the questionnaire. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Other Pre-specified | 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. | 3 of the devices were not returned. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure". 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. Usual Care: Usual Care | 0 | 51 | 0 | 51 | 0 | 51 |
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