Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)

Tulane University

Status: Completed

Conditions: Hypertension; Blood Pressure

Treatments: Behavioral: Multicomponent Intervention; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03483662

R01HL133790 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.

Full 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) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mm Hg) among hypertensive patients aged ≥50 years. SPRINT clearly answered the question - Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in underserved patients. The IMPACTS trial is an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention program for more intensive BP treatment and the feasibility and fidelity of implementing the program in underserved patients with hypertension in Louisiana and Mississippi. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including dissemination of SPRINT study findings among patients, providers and policymakers; team-based collaborative care using a stepped-care protocol adapted from the SPRINT intensive-treatment algorithm, BP audit and feedback, and home BP monitoring; and health coaching on antihypertensive medication adherence and lifestyle modification. The investigators will collaborate with 36 federally qualified health center clinics that serve low-income populations in Louisiana and Mississippi to recruit 1,260 trial participants and conduct the IMPACTS trial. The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months. The fidelity of the intervention, measured by intensification of treatment by providers and adherence to medications in patients, will be the primary implementation outcome. This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.

Enrollment: 1,272 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,272 participants in 2 patient groups

Multicomponent Intervention

Experimental group

Description:

Protocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification

Treatment:

Behavioral: Multicomponent Intervention

Enhanced Usual Care

Active Comparator group

Description:

Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings

Treatment:

Behavioral: Enhanced Usual Care