Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial - 26/11/20

Doi : 10.1016/j.ahj.2020.08.009

Katherine T. Mills, PhD ^a,^c, Erin Peacock, PhD ^b, Jing Chen, MD, MSc ^a,^b,^c, Amanda Zimmerman, MPH ^a, Kenya Brooks, MPH ^a, Hua He, PhD ^a,^c, Alecia Cyprian, PhD ^d, Gerrelda Davis, MBA ^e, Sonja R. Fuqua, PhD, RN ^f, Angelique Greer, MPH ^g, Lea Gray-Winfrey, DNP, APRN ^h, Shondra Williams, PhD, APRN ⁱ, Gary M. Wiltz, MD ^j, Keith L. Winfrey, MD, MPH ^k, Paul K. Whelton, MD, MSc ^a,^b,^c, Marie Krousel-Wood, MD, MSPH ^a,^b,^c, Jiang He, MD, PhD ^a,^b,^c,^{^⁎}
^a Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA
^b Department of Medicine, Tulane University School of Medicine, New Orleans, LA
^c Tulane University Translational Sciences Institute, New Orleans, LA
^d Southeast Community Health Systems, Greensburg, LA
^e Louisiana Primary Care Association, Baton Rouge, LA
^f Community Health Center Association of Mississippi, Jackson, MS
^g Coastal Family Health Center, Biloxi, MS
^h EXCELth, Inc., New Orleans, LA
ⁱ InclusivCare, Avondale, LA
^j Teche Action Board, Inc., Franklin, LA
^k NOELA Community Health Center, New Orleans, LA

^⁎Reprint requests: Jiang He, MD, PhD, Tulane University School of Public Health and Tropical Medicine, 1440 Canal St, Suite 2000, New Orleans, LA 70112Tulane University School of Public Health and Tropical Medicine1440 Canal St, Suite 2000New OrleansLA70112

Abstract

Background

The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.

Methods

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0–mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.

Conclusions

IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.

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Plan

Methods

Objectives and specific aims

Study setting and participants

Multifaceted intervention program

Clinical effectiveness and implementation outcomes

Data collection

Adverse events

Data analysis and statistical power

Protection of human subjects

Funding sources

Study enrollment and timeline

Conclusions

☆	Declarations of interest: None.
☆☆	Trial registration: Clinicaltrials.gov number NCT03483662.

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Vol 230

P. 13-24 - décembre 2020 Retour au numéro

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Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial - 26/11/20

Abstract

Background

Methods

Conclusions

Plan

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