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

NCT ID: NCT03143881

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2017-01-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: 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.

Control

Control patients will receive ED standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Vishwaratn Asthana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishwaratn Asthana

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

William Peacock

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Other Identifiers

32676

Identifier Type: -

Identifier Source: org_study_id