Status:
COMPLETED
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)
Lead Sponsor:
Tulane University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for...
Detailed Description
Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP\<120 mm Hg) reduced major cardiovascular disease (CVD) ...
Eligibility Criteria
Inclusion
- Eligibility Criteria for Clinics:
- Affiliated with participating FQHCs and not sharing providers or nurses/pharmacists with other clinics.
- Predominantly managing underserved populations with health disparities (ethnic minorities, low-income groups, and residents of rural areas and inner cities).
- Having electronic medical record systems.
- Serving \>200 hypertension patients (ICD-10-CM I10-I15) during the previous year.
- Not participating in other hypertension control programs.
- Inclusion Criteria for Study Participants:
- Men or women aged ≥40 years who receive primary care from the participating FQHC clinics.
- Systolic BP ≥140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications.
- Exclusion Criteria for Study Participants:
- Not able to understand English
- Pregnant women, women planning to become pregnant in the next 18 months, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent.
- Plans to change to a primary healthcare provider outside of the FQHC clinic during the next 18 months.
- Diagnosis of end-stage renal disease, defined as dialysis or transplantation.
- Individuals unlikely to complete the study, such as those who plan to move out the study area during the next 18 months, temporary migrant workers, and homeless persons.
- Patients with immediate family members who are staff at their FQHC clinic.
Exclusion
Key Trial Info
Start Date :
June 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT03483662
Start Date
June 27 2018
End Date
February 15 2024
Last Update
July 9 2025
Active Locations (2)
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1
26 FQHC Primary Care Clinics in Louisiana
New Orleans, Louisiana, United States, 70112
2
10 FQHC Primary Care Clinics in Mississippi
Biloxi, Mississippi, United States, 39530