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
About this trial
This is an interventional treatment trial for Heart Failure
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.
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
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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