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

NCT03483662 | Completed DMC

• 1 other identifier: R01HL133790
• Study Type: interventional
• Target: 1,272
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Hypertension; Blood Pressure

Keywords

hypertension; blood pressure; medication adherence; lifestyle modification; blood pressure control; implementation

Outcome Measures

Primary Outcomes (2)

• Difference in mean change of systolic BP

  The primary outcome is the difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups. Blood pressure will be measured 3 times each at two baseline, one 6-month, one 12-month, and two termination visits according to a standard protocol.

  Baseline to 18 months

• Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.

  A fidelity summary score includes adherence to antihypertensive medications, initiation or intensification of treatment, home BP monitoring, and health education over the intervention period. The fidelity summary score ranges from 0 (worst) to 4 (best)

  Baseline to 18 months

Secondary Outcomes (14)

• Proportion of patients with systolic blood pressure <120 mm Hg

  Baseline to 18 months

• Proportion of patients with systolic blood pressure <130 mm Hg

  Baseline to 18 months

• Proportion of patients with a >30 mm Hg reduction in systolic blood pressure

  Baseline to 18 months

• Difference in mean change of diastolic blood pressure

  Baseline to 18 months

• Health-related quality of life (SF-12)

  Baseline to 18 months

Study Arms (2)

Multicomponent Intervention

EXPERIMENTAL

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

Behavioral: Multicomponent Intervention

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

Multicomponent Intervention BEHAVIORAL

The core component of the intervention is protocol-based treatment using the SPRINT BP management algorithm. The following implementation strategies are adaptable components that will be modified to fit specific federally-qualified health center (FQHC) settings: 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.

Multicomponent Intervention

Enhanced Usual Care BEHAVIORAL

The investigators will provide an up-to-date clinical guideline for hypertension management to providers. A webinar education session on the new American College of Cardiology (ACC)/American Heart Association (AHA) hypertension guideline and findings from the SPRINT trial will be conducted. Otherwise, the investigators will not conduct any active intervention and all control clinics will follow their routine clinic practice in the management of hypertensive patients

Enhanced Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

26 FQHC Primary Care Clinics in Louisiana

New Orleans, Louisiana, 70112, United States

Location

10 FQHC Primary Care Clinics in Mississippi

Biloxi, Mississippi, 39530, United States

Location

Related Publications (2)

• Mills KT, Peacock E, Chen J, Zimmerman A, He H, Cyprian A, Davis G, Fuqua SR, Gilliam DS, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic. J Am Heart Assoc. 2021 Feb 2;10(3):e018510. doi: 10.1161/JAHA.120.018510. Epub 2020 Dec 3.

  PMID: 33267723 DERIVED

• Mills KT, Peacock E, Chen J, Zimmerman A, Brooks K, He H, Cyprian A, Davis G, Fuqua SR, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial. Am Heart J. 2020 Dec;230:13-24. doi: 10.1016/j.ahj.2020.08.009. Epub 2020 Aug 19.

  PMID: 32827458 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jiang He, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

• Marie A Krousel-Wood, MD, MPH

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: March 30, 2018
• Study Start: June 27, 2018
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 9, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data sets will be submitted to the study NHLBI study Program Official no later than 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• Access Criteria: The investigators will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.

Locations

US (2)