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

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ClinicalTrials.gov Identifier: NCT03483662
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University

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 acceptability, adoption, feasibility, fidelity, and sustainability of the multifaceted implementation strategy in patients, providers, and healthcare systems.

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Behavioral: Multicomponent Intervention Behavioral: Enhanced Usual Care Not Applicable

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, fidelity, and sustainability of implementing the program in underserved patients with hypertension in Louisiana, Alabama, 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, adoptable, and sustainable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Quality of life [ Time Frame: Baseline to 18 months ]
    Health-related quality of life will be assessed using the Medical Outcomes Study 20-Item Short-Form Health Survey (MOS-20).


Other Outcome Measures:
  1. 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.

  2. Medication Adherence (fidelity) [ Time Frame: Baseline to 18 months ]
    Patient medication adherence will be assessed by questionnaire.

  3. Other implementation outcomes: acceptability, adoption, appropriateness, feasibility, and sustainability [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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 for Study Participants:

  • Not able to read and 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483662


Contacts
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Contact: Erin Peacock, PhD 504-988-1075 epeacoc@tulane.edu
Contact: Katherine T Mills, PhD 504-988-4749 kmills4@tulane.edu

Sponsors and Collaborators
Tulane University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jiang He, MD, PhD Tulane University
Principal Investigator: Marie A Krousel-Wood, MD, MPH Tulane University

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Responsible Party: Jiang He, MD, PhD, Professor and Department Chair, Tulane University
ClinicalTrials.gov Identifier: NCT03483662    
Other Study ID Numbers: R01HL133790 ( U.S. NIH Grant/Contract )
R01HL133790 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiang He, MD, PhD, Tulane University:
hypertension
blood pressure
medication adherence
lifestyle modification
blood pressure control
implementation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases