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

July 4, 2025 updated by: Jiang He, MD, PhD, Tulane University

Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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) 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • 26 FQHC Primary Care Clinics in Louisiana
    • Mississippi
      • Biloxi, Mississippi, United States, 39530
        • 10 FQHC Primary Care Clinics in Mississippi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multicomponent Intervention
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
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.
Active Comparator: Enhanced Usual Care
Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings
Behavioral: Enhanced Usual Care
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in mean change of systolic BP
Time Frame: Baseline to 18 months
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.
Time Frame: Baseline to 18 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with systolic blood pressure <120 mm Hg
Time Frame: Baseline to 18 months
The differences in the proportion of patients with systolic blood pressure <120 mm Hg between the intervention and control groups at 18 months will be assessed.
Baseline to 18 months
Proportion of patients with systolic blood pressure <130 mm Hg
Time Frame: Baseline to 18 months
The differences in the proportion of patients with systolic blood pressure <130 mm Hg between the intervention and control groups at 18 months will be assessed.
Baseline to 18 months
Proportion of patients with a >30 mm Hg reduction in systolic blood pressure
Time Frame: Baseline to 18 months
The differences in the proportion of patients with a >30 mm Hg reduction in systolic blood pressure between the intervention and control groups at 18 months will be assessed.
Baseline to 18 months
Difference in mean change of diastolic blood pressure
Time Frame: Baseline to 18 months
The difference in mean change of diastolic blood pressure from baseline to 18 months between intervention and control groups will be assessed.
Baseline to 18 months
Health-related quality of life (SF-12)
Time Frame: Baseline to 18 months
Health-related quality of life will be assessed using the 12-Item Short Form Survey (SF-12). Physical component summary (PCS-12) and mental component summary (MCS-12) scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Baseline to 18 months
Intensification of treatment (fidelity)
Time Frame: Baseline to 18 months
Survey data and electronic health record data will be used to assess whether providers add new antihypertensive medications or titrate existing medications. Intensification of antihypertension treatment is a binary outcome variable, with 1 representing the initiation of a new medication or an increase in the current medication dosage, and 0 representing no change in medication.
Baseline to 18 months
Medication adherence (fidelity)
Time Frame: Baseline to 18 months
Patient medication adherence will be assessed by questionnaire. Binary variable: 1=high adherence and 0=low adherence
Baseline to 18 months
Self-reported home BP monitoring (fidelity)
Time Frame: Baseline to 18 months
Patient home BP monitoring will be assessed by questionnaire. Binary variable: 1=yes and 0=no
Baseline to 18 months
Self-reported health education at previous clinic visits (fidelity)
Time Frame: Baseline to 18 months
Patient health education at previous clinic visits will be assessed by questionnaire. Binary variable: 1=yes and 0=no.
Baseline to 18 months
Satisfaction with antihypertensive medications
Time Frame: Baseline to 18 months
The satisfaction of patients with antihypertensive medications was assessed at baseline and follow-up visits using the question, 'How satisfied are you with antihypertensive medications you have received?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Baseline to 18 months
Satisfaction with BP-related care
Time Frame: Baseline to 18 months
The satisfaction of patients with BP-related care was assessed at baseline and follow-up visits using the question, 'How satisfied are you with the care you have received for your blood pressure?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Baseline to 18 months
Acceptance to intensive BP target by providers in intervention clinics
Time Frame: Baseline to 18 months
Survey among providers
Baseline to 18 months
Adherence to clinical appointments in the intervention group
Time Frame: Baseline to 18 months
Study administrative data
Baseline to 18 months
Adherence to health coach session in the intervention group
Time Frame: Baseline to 18 months
Study administrative data
Baseline to 18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensification of Treatment (fidelity)
Time Frame: Baseline to 18 months
Electronic health record data will be used to assess whether providers add new antihypertensive medications or titrate existing medications.
Baseline to 18 months
Medication Adherence (fidelity)
Time Frame: Baseline to 18 months
Patient medication adherence will be assessed by questionnaire.
Baseline to 18 months
Other implementation outcomes: acceptability, adoption, appropriateness, and feasibility
Time Frame: Baseline to 30 months
Other implementation outcomes will be obtained at baseline and follow-up visits using questionnaire surveys and administrative (EHR) data.
Baseline to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tulane University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie A Krousel-Wood, MD, MPH, Tulane University
  • Principal Investigator: Jiang He, MD, PhD, Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HL133790 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository. The study data will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." At the completion of the project, the investigators will make all intervention materials and procedure manuals available to the public according to the approved plan for making data and materials available to the scientific community, lay public, and the NIH.

IPD Sharing 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.

IPD Sharing Access Criteria

The investigators will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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