Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations (IMPACTS)

  • STATUS
    Recruiting
  • End date
    Jun 11, 2023
  • participants needed
    1260
  • sponsor
    Tulane University
Updated on 11 October 2022
diabetes
hypertension
stroke
myocardial infarction
infarct
nephropathy
antihypertensive drugs

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 intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the acceptability, adoption, feasibility, and fidelity of the multifaceted implementation strategy in patients, providers, and healthcare systems.

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, Alabama, 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.

Details
Condition Hypertension, Blood Pressure
Treatment Enhanced usual care, Multicomponent intervention
Clinical Study IdentifierNCT03483662
SponsorTulane University
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
High risk for CVD, defined as history of CVD (myocardial infarction, stroke or heart failure), chronic kidney disease (CKD, estimate glomerular filtration rate (eGFR) <60 ml/min/1.73m2), diabetes, estimated 10-year global CVD risk ≥10%, or age ≥65 years

Exclusion Criteria

Not able to understand English
Pregnant women, women planning to become pregnant in the next 18 months, 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
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
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