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Enhancing Systems of Care to Improve Hypertension Guideline Implementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563872
Recruitment Status : Withdrawn (Lack of funding)
First Posted : June 20, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph Miller, MD, Henry Ford Health System

Study Description
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Brief Summary:
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.

Condition or disease Intervention/treatment Phase
Hypertension Other: Intervention Other: Active Comparator Not Applicable

Detailed Description:

The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led.

The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Comparator
Team-based care
 Other: Active Comparator
Usual, team-based care
Experimental: Intervention
Enhanced team-based care
 Other: Intervention
Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.


Outcome Measures
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Primary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: 12 months ]
    mean change


Secondary Outcome Measures :
  1. Therapeutic Intensity [ Time Frame: 12 months ]
    Calculated therapeutic intensity score

  2. Change in systolic blood pressure [ Time Frame: 6 months ]
    mean change

  3. Change in diastolic blood pressure [ Time Frame: 12 months ]
    mean change

  4. Treatment Congruence [ Time Frame: 12 months ]
    Proportion of clinical encounters in which treatment is congruent with guidelines


Other Outcome Measures:
  1. Cost effectiveness [ Time Frame: 12 months ]
    within trial cost and long-term projected costs compared to QALY


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years) African Americans
  • Lacks established primary care for BP management
  • History of HTN
  • SBP ≥ 140 mmHg

Exclusion Criteria:

  • Pregnancy
  • Need for hospitalization from ED
  • Serious comorbid conditions
  • Alcohol or drug dependence
  • Suspected resistant HTN
  • Anticipated poor-adherence to study designated primary care clinic
Contacts and Locations
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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): NCT03563872


Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
More Information
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Responsible Party: Joseph Miller, MD, Senior Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03563872    
Other Study ID Numbers: 13455
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Joseph Miller, MD, Henry Ford Health System:
hypertension
team-based
guidelines
implementation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases