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Heart Failure Evaluation Acute Referral Team Trial (HEARTT)

Primary Purpose

Heart Failure, Congestive

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
education: disease, medication, self-care, diet
Sponsored by
University of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring heart failure, congestive, patient care team, randomized controlled trial, disease management, drug therapy, diet therapy, hospitalization, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients presenting to the emergency department (ED) with signs and symptoms of heart failure with a plan to discharge home from the ED . Exclusion Criteria: < 18 years of age planned follow-up with Cardiology or Internal Medicine post discharge from ED heart transplant candidate or recipient current Heart Function Clinic patient left ventricular ejection fraction >0.40 unable or unwilling to attend clinic visits heart failure requiring admission to hospital patients living outside the Capital Health catchment area participation in another heart failure clinical trial

Sites / Locations

  • University of Alberta Hospital

Outcomes

Primary Outcome Measures

Difference in the composite endpoint of emergency room visits, hospitalizations, and mortality at 6 months between the intervention and usual care group.

Secondary Outcome Measures

Difference in the following between the intervention and usual care groups at 6 months: emergency room visits, hospitalizations, mortality, proportion of patients utilizing evidence-based therapies, quality of life
Description of the implementation of the rapid assessment clinic
Patient satisfaction

Full Information

First Posted
July 18, 2006
Last Updated
April 25, 2015
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT00355511
Brief Title
Heart Failure Evaluation Acute Referral Team Trial (HEARTT)
Official Title
Heart Failure Evaluation Acute Referral Team Trial (HEARTT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
unable to recruit patients
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the impact of a multidisciplinary team clinic including a clinical pharmacist, a registered nurse (RN), dietician and physician providing short-term sub-acute management of patients with heart failure on patient outcomes and the quality of medication use. Patients being discharged from the emergency department with a diagnosis of heart failure will be eligible for this study. We believe that emergency room visits, hospitalization and deaths secondary to heart failure will decrease secondary to this program.
Detailed Description
BACKGROUND: Heart failure (HF)accounts for morbidity and mortality in Canada. In contrast to coronary heart disease, the mortality rate attributed to HF has decreased minimally, only 14%, over the last 35 years. This is despite a plethora of new therapeutic modalities proven to decrease mortality in HF. HF is also one of the leading causes of hospitalizations accounting for the second highest total number of hospital days and the third highest number of patients affected. It has been estimated that approximately 20-50% of patients will be readmitted to hospital with one year. Patients seen in the emergency department (ED)and discharged home from the ED are also at high risk for readmissions. A local study by our group indicated that 44% of patients seen for HF in the ED have this disposition and as such have a strikingly 50% higher readmission rate at 30 days compared to those admitted to hospital. This difference could be explained by a "care gap" as evidence by a low utilization of both angiotensin converting enzyme inhibitors and beta-blockers in this group. However, a lack of patient education on self-care and follow-up post ED discharge could also attribute to these rates. We propose testing a intervention employing a multidisciplinary team to facilitate follow-up, provide HF education, including self-care, and improve utilization of proven drug-therapy in patients discharged with HF from the ED on the outcomes of hospitalizations and mortality. PURPOSE: To improve the quality of care for patient with HF HYPOTHESIS: Multidisciplinary team management of patients with HF has be shown to decrease both morbidity and mortality in HF patients. A multifaceted program including rapid referral, early short-term follow-up, medication initiation and titration and HF education in collaboration with a dietician, nurse, pharmacist and physician will improve HF patient care in terms of clinical outcomes, quality of life and evidence-based medication utilization. STUDY DESIGN: The study will utilize an unblinded randomized controlled trial (RCT) design. Eligible patients will included patient discharged from the ED with a diagnosis of heart failure. All patients referred from the ED will be seen in a rapid referral clinic within 1 week. Eligible patients will then randomized to an intervention arm or usual care. The usual care group will have a consultation letter with recommendations sent their family doctor and will receive a booklet on heart failure. The intervention arm will be followed in clinic monthly by the multidisciplinary team. Medication will be initiated and titrated to target dose. Patients will receive education regarding heart failure, medications, lifestyle, diet and self-management. Communication will the patient's primary care provider will also be enhanced. SIGNIFICANCE: The literature describes a plethora of therapeutic modalities aimed at improving the care of patients with HF. However, in terms of multifaceted disease management interventions, the majority of HF studies have examined high risk patients that were admitted to hospital or stable outpatients. This proposed study would examine a unique population of patients being discharged from the emergency department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
heart failure, congestive, patient care team, randomized controlled trial, disease management, drug therapy, diet therapy, hospitalization, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
education: disease, medication, self-care, diet
Intervention Description
education on heart failure self care; medication initiation and titration, frequent follow-up
Primary Outcome Measure Information:
Title
Difference in the composite endpoint of emergency room visits, hospitalizations, and mortality at 6 months between the intervention and usual care group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in the following between the intervention and usual care groups at 6 months: emergency room visits, hospitalizations, mortality, proportion of patients utilizing evidence-based therapies, quality of life
Time Frame
6 months
Title
Description of the implementation of the rapid assessment clinic
Time Frame
6 months
Title
Patient satisfaction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting to the emergency department (ED) with signs and symptoms of heart failure with a plan to discharge home from the ED . Exclusion Criteria: < 18 years of age planned follow-up with Cardiology or Internal Medicine post discharge from ED heart transplant candidate or recipient current Heart Function Clinic patient left ventricular ejection fraction >0.40 unable or unwilling to attend clinic visits heart failure requiring admission to hospital patients living outside the Capital Health catchment area participation in another heart failure clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross T Tsuyuki, PharmD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://www.epicore.ualberta.ca
Description
Related Info

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Heart Failure Evaluation Acute Referral Team Trial (HEARTT)

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