Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143881
Other study ID # 32676
Secondary ID
Status Completed
Phase N/A
First received May 4, 2017
Last updated May 5, 2017
Start date June 1, 2015
Est. completion date January 1, 2017

Study information

Verified date May 2017
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date January 1, 2017
Est. primary completion date March 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 and 90 days
Primary 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. 30 and 90 days
Secondary Days alive and out of hospital (DAOH) Days alive and out of hospital (DAOH) over a 365 day period post-index visit 365 days (1 year)
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy