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OpenTrials
Completed

NCT Number: NCT03143881

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

Behavioral

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 outcomes

  1. Change in ED revisits

    Time frame: 30 and 90 days

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

  2. Change in hospital readmissions

    Time frame: 30 and 90 days

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

Secondary outcomes

  1. Days alive and out of hospital (DAOH)

    Time frame: 365 days (1 year)

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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 8, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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