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Comparison of Outcomes and Access to Care for Heart Failure Trial (COACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674438
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Douglas Lee, Institute for Clinical Evaluative Sciences

Brief Summary:

Heart failure is a condition where the heart pump does not function normally causing the lungs to become congested. The primary symptom of heart failure is shortness of breath, and this often leads to patients visiting the emergency department for care. Decision-making in the emergency department is a high-stakes situation, where there is a need for decision support to guide clinicians to make better decisions about admission to hospital or discharge home. Many low-risk patients who could potentially be managed at home are admitted to hospital whereas some patients who are thought safe to discharge are actually high risk and will have adverse outcomes if they are discharged home from the emergency department.

In this trial, the investigators will study a new strategy for heart failure care, comprised of a computer algorithm to help doctors make decisions in the emergency department about the risk of their patient. For low-risk patients who are discharged home from the emergency department or after a short hospital stay, patients will be referred to a rapid follow-up clinic where the heart specialist team will rapidly assess and treat patients.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Risk stratification and transitional care intervention Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparison of Outcomes and Access to Care for Heart Failure Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Active Intervention

Two components to the intervention: (1) clinical algorithm for prognostication, and (2) post-discharge follow-up in the RAPID-HF clinic

Intervention #1 - Clinical algorithm: the EHMRG30-ST risk score which will be used to categorize patients as high, intermediate, or low risk. The clinical algorithm will be used to guide clinicians to decide on admission to hospital, observation during a short stay hospital admission (3 days or less), or emergency department discharge.

Intervention #2 - Referral to RAPID-HF (Rapid Ambulatory Program for Investigation and Diagnosis of HF) transitional care clinic: visit to RAPID-HF within 48-72 hours of discharge. Care provided in RAPID-HF by cardiologist + nurse for up to 30 days from date of discharge.

Other: Risk stratification and transitional care intervention

Intervention consists of 2 components:

  1. Risk stratification: Determination of risk using the EHMRG 7-day and 30-day risk scores (EHMRG30-ST), where decision to admit, observe, or discharge the patient will be guided by the result of the risk scores
  2. Transitional care: Follow-up care in the RAPID-HF transitional care clinic begins at 48-72 hours after emergency department or hospital discharge. Care provided by cardiologist + nurse for up to 30 days after emergency department or hospital discharge.

No Intervention: Control
Usual care without access to the EHMRG30-ST scoring system, decision algorithm, or RAPID-HF clinic.



Primary Outcome Measures :
  1. Co-primary outcome: 30 day early events [ Time Frame: 30 days ]
    Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day)

  2. Co-primary outcome: 20 month extended events [ Time Frame: 20 month follow-up ]
    Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day)


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 30 days ]
    Time to death

  2. Cardiovascular hospitalization [ Time Frame: 30 days ]
    Time to cardiovascular hospitalization (nonelective, los > 1 day)

  3. Heart failure hospitalization [ Time Frame: 30 days ]
    Time to heart failure hospitalization (nonelective, los > 1 day)

  4. All-cause death [ Time Frame: 20 months ]
    Time to death (nonpalliative)

  5. Cardiovascular hospitalization [ Time Frame: 20 months ]
    Time to cardiovascular hospitalization (nonelective, los > 1 day)

  6. Heart failure hospitalization [ Time Frame: 20 months ]
    Time to heart failure hospitalization (nonelective, los > 1 day)


Other Outcome Measures:
  1. Patient-centered outcome [ Time Frame: 1) 30-day and 2) 20 month ]
    Time to nonelective emergency department visit (CTAS 1-4), death or cardiovascular hospitalization

  2. Early discharge [ Time Frame: 3 days ]
    Proportion of patients discharged within 3 days of emergency presentation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient presenting to an emergency department with heart failure

Exclusion Criteria:

  • Palliative or DNR
  • Dialysis dependent
  • Non-Ontario resident

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674438


Locations
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Canada, Ontario
Toronto Genera Hospital
Toronto, Ontario, Canada, M5G2C4
Sponsors and Collaborators
Institute for Clinical Evaluative Sciences
Investigators
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Principal Investigator: Douglas Lee, MD, PhD University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Douglas Lee, Senior Scientist, Institute for Clinical Evaluative Sciences
ClinicalTrials.gov Identifier: NCT02674438    
Other Study ID Numbers: 2
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to Ontario privacy regulations, unable to share data
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases