NCT03143881

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

May 4, 2017

Last Update Submit

May 5, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Days alive and out of hospital (DAOH)

    365 days (1 year)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Education

Control

NO INTERVENTION

Control patients will receive ED standard of care.

Interventions

EducationBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Vishwaratn Asthana

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
  • William Peacock

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

June 1, 2015

Primary Completion

March 31, 2016

Study Completion

January 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05