Implementing Hypertension Screening Guidelines in Primary Care (NCT03480217) | Clinical Trial Compass
CompletedNot Applicable
Implementing Hypertension Screening Guidelines in Primary Care
United States1,186 participantsStarted 2018-04-01
Plain-language summary
The goal of this study is to use a cluster-randomized design (1:1 ratio) among 8 primary care clinics affiliated with New York-Presbyterian Hospital to test the effectiveness of a theory-informed multifaceted implementation strategy designed to increase the uptake of the 2015 United States Preventive Services Task Force (USPSTF) hypertension screening guidelines. The primary outcome is the ordering of out-of-office blood pressure testing, either ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM), by primary care clinicians for patients with newly elevated office blood pressure (BP), as recommended by the 2015 guidelines.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient Inclusion Criteria (as per electronic medical records):
* Elevated blood pressure (BP) (systolic BP\>=140 mmHg or diastolic BP \>=90 mmHg) at a scheduled clinic visit with a primary care provider from a clinic that is participating in the study; if multiple BP readings were taken from a visit, then the average of the readings will be used
Patient Exclusion Criteria (as per electronic medical records):
* Prior diagnosis of hypertension
* Prior diagnosis of white-coat hypertension
* Prior evaluation for white-coat hypertension by 24-hr ABPM or HBPM
* Prescribed antihypertensive medication
* Manual office BP \<140/90 mmHg
* Severely elevated BP (systolic BP\>=180 mmHg or diastolic BP\>=110 mmHg)
* Evidence of target-organ damage (chronic kidney disease, cardiovascular disease)
Clinic Inclusion Criteria:
* Primary care clinics that are part of the New York-Presbyterian Hospital Ambulatory Care Network and were not part of implementation development
Clinic Exclusion Criteria:
* Medical director of clinic declines to participate in cluster randomized trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period
Timeframe: 6 months (Pre-Implementation period)
2
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period