Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Palliative Care for Patients With Advanced Heart Disease (FLAME)

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: NCT02302014
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Patients admitted as an unscheduled hospital admission with either a acute heart failure syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated to receive a holistic care intervention based around the creation of a detailed Future (anticipatory) Care Plan which is agreed with the patient and their family and which is shared with the Family Doctor and Emergency Services including ambulance teams. Primary endpoint is quality of life assessed by questionnaire.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Congestive Cardiac Failure Palliative Care Other: Palliative Care Intervention Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Trial of Early Versus Delayed Future Care Planning for Patients and Families Living With Advanced Heart Disease
Study Start Date : August 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Palliative Care Intervention
Baseline interview with trial cardiologist and trial nurse lasting for up to 1 hour Creation of a Future Care Plan (FCP) document following this baseline interview Sharing of FCP document with primary care and unscheduled care organisations 6 week interview with trial nurse lasting for up to 1 hour to review FCP 12 week interview with trial nurse lasting for up to 1 hour to review FCP Continuous access to trial nurse by mobile telephone 9am - 5pm Monday-Friday for 12 weeks Trial nurse will - ensure FCP is appropriately shared with primary and secondary care, patient is registered on primary care palliative care register and will liaise with specialist PC services and the general practitioner as needed.
Other: Palliative Care Intervention
Baseline interview with trial cardiologist and trial nurse lasting for up to 1 hour Creation of a Future Care Plan (FCP) document following this baseline interview Sharing of FCP document with primary care and unscheduled care organisations 6 week interview with trial nurse lasting for up to 1 hour to review FCP 12 week interview with trial nurse lasting for up to 1 hour to review FCP Continuous access to trial nurse by mobile telephone 9am - 5pm Monday-Friday for 12 weeks Trial nurse will - ensure FCP is appropriately shared with primary and secondary care, patient is registered on primary care palliative care register and will liaise with specialist PC services and the general practitioner as needed.

No Intervention: Usual Care
Usual Care



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
    EuroQoL5D


Secondary Outcome Measures :
  1. Hospital Readmissions [ Time Frame: 6 months ]
    Unscheduled or non-elective admissions to hospital

  2. Place of Death [ Time Frame: 6 months ]
    Hospital, hospice or home

  3. DNACPR status documented [ Time Frame: 6 months ]
    Evidence of a discussion and agreed plan for Resuscitation Status of the patient

  4. Mortality [ Time Frame: 6 months ]
    All cause mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Age > 18 years Unscheduled hospital admission due to congestive heart failure and or acute coronary syndrome 12 month estimated mortality risk of 20% or greater Optimal tolerated medical and device therapy

Exclusion Criteria:

Expected survival < 28 days Other life limiting non-cardiac condition likely to cause death within 12 months Moderate or severe dementia Moderate or severe cognitive impairment


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): NCT02302014


Locations
Layout table for location information
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Investigators
Layout table for investigator information
Principal Investigator: Martin A Denvir, MBChB University of Edinburgh
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02302014    
Other Study ID Numbers: Marie Curie FLAME trial
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Acute Coronary Syndrome
Heart Failure
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases