NCT00355511

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

July 18, 2006

Last Update Submit

April 25, 2015

Conditions

Keywords

heart failure, congestivepatient care teamrandomized controlled trialdisease managementdrug therapydiet therapyhospitalizationmortality

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (3)

  • 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

    6 months

  • Description of the implementation of the rapid assessment clinic

    6 months

  • Patient satisfaction

    6 months

Interventions

education on heart failure self care; medication initiation and titration, frequent follow-up

Eligibility Criteria

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

You may qualify if:

  • Patients presenting to the emergency department (ED) with signs and symptoms of heart failure with a plan to discharge home from the ED .

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Dosage FormsSelf CareDiet

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesTherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ross T Tsuyuki, PharmD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 24, 2006

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations