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Assessment Of Educational Strategies In Heart Failure Patients Presenting To The Emergency Department For Care

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a pre-existing documented diagnosis of HF presenting to the ED

Exclusion Criteria:

  • 1) Patients in unstable condition requiring immediate medical attention, 2) hemodynamically unstable, 3) age < 18 years, and/or 4) incarcerated.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Intervention patients will receive personalized education regarding their condition, pre- and post-testing of their HF knowledge base, and ED standard of care during the enrollment (index) visit. Patients will then be contacted via telephone 30 days post-index visit for re-testing and reinforcement of previously learned material.

    Control patients will receive ED standard of care.

    Outcomes

    Primary Outcome Measures

    Change in ED revisits
    Change in the number of HF-specific ED revisits over the 30- and 90-day periods, pre- and post-index visit.
    Change in hospital readmissions
    Change in the number of HF-specific hospital readmissions over the 30- and 90-day periods, pre- and post-index visit.

    Secondary Outcome Measures

    Days alive and out of hospital (DAOH)
    Days alive and out of hospital (DAOH) over a 365 day period post-index visit

    Full Information

    First Posted
    May 4, 2017
    Last Updated
    May 5, 2017
    Sponsor
    Baylor College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03143881
    Brief Title
    Assessment Of Educational Strategies In Heart Failure Patients Presenting To The Emergency Department For Care
    Official Title
    Assessment Of Patient Knowledge And Effects Of Educational Strategies In Un- And Under-Insured Heart Failure Patients Presenting To The Emergency Department For Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    March 31, 2016 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baylor College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the impact of a new education-based intervention on outcomes in un- and under-insured Heart Failure (HF) patients presenting to the Emergency Department (ED) for care. Intervention patients will receive personalized education regarding their condition, pre- and post-testing of their HF knowledge base, and ED standard of care during the enrollment (index) visit. Patients will then be contacted via telephone 30 days post-index visit for re-testing and reinforcement of previously learned material. Patients in the control group will receive ED standard of care.
    Detailed Description
    In 2015, 12.8% of adults ages 19-64 in the United States lacked any form of health insurance. An even greater number fell under the umbrella of under-insured. Studies indicate that the un- and under-insured receive less preventive care, are diagnosed at more advanced disease stages, and have higher mortality rates than their insured counterparts, due to the lack of accessible primary care services. These issues are most readily evident in patients with chronic conditions. When a preventable, chronic condition worsens, these patients have no choice but to visit the ED to address their most immediate health concerns, leaving the underlying chronic problem untreated. HF is a particularly burdensome chronic problem for patients of all socioeconomic statuses and one of the leading causes of ED and hospital readmissions. Numerous educational efforts have been tested in an attempt to reduce HF readmissions but have met with mixed results. Consequently, HF patients are generally seen as refractory to educational and management strategies. The investigators propose here a new, targeted educational intervention designed to improve patient outcomes and readmission rates in un- and underinsured HF patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention patients will receive personalized education regarding their condition, pre- and post-testing of their HF knowledge base, and ED standard of care during the enrollment (index) visit. Patients will then be contacted via telephone 30 days post-index visit for re-testing and reinforcement of previously learned material.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control patients will receive ED standard of care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education
    Intervention Description
    Standardized information on the etiology of HF, mechanisms and side effects of medications prescribed, strategies for minimizing exacerbations, and warning signs of worsening clinical status will be discussed with the patient.
    Primary Outcome Measure Information:
    Title
    Change in ED revisits
    Description
    Change in the number of HF-specific ED revisits over the 30- and 90-day periods, pre- and post-index visit.
    Time Frame
    30 and 90 days
    Title
    Change in hospital readmissions
    Description
    Change in the number of HF-specific hospital readmissions over the 30- and 90-day periods, pre- and post-index visit.
    Time Frame
    30 and 90 days
    Secondary Outcome Measure Information:
    Title
    Days alive and out of hospital (DAOH)
    Description
    Days alive and out of hospital (DAOH) over a 365 day period post-index visit
    Time Frame
    365 days (1 year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a pre-existing documented diagnosis of HF presenting to the ED Exclusion Criteria: 1) Patients in unstable condition requiring immediate medical attention, 2) hemodynamically unstable, 3) age < 18 years, and/or 4) incarcerated.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vishwaratn Asthana
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    William Peacock
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Assessment Of Educational Strategies In Heart Failure Patients Presenting To The Emergency Department For Care

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