Palliative Care for Patients With Advanced Heart Disease

NCT02302014 | Completed Phase 2

• 1 other identifier: Marie Curie FLAME trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Congestive Cardiac Failure; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  EuroQoL5D

  6 months

Secondary Outcomes (4)

• Hospital Readmissions

  6 months

• Place of Death

  6 months

• DNACPR status documented

  6 months

• Mortality

  6 months

Study Arms (2)

Palliative Care Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual Care

Interventions

Palliative Care Intervention OTHER

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.

Palliative Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (2)

• Denvir MA, Highet G, Robertson S, Cudmore S, Reid J, Ness A, Hogg K, Weir C, Murray S, Boyd K. Future Care Planning for patients approaching end-of-life with advanced heart disease: an interview study with patients, carers and healthcare professionals exploring the content, rationale and design of a randomised clinical trial. BMJ Open. 2014 Jul 14;4(7):e005021. doi: 10.1136/bmjopen-2014-005021.

  PMID: 25023130 BACKGROUND

• Anand A, Cudmore S, Robertson S, Stephen J, Haga K, Weir CJ, Murray SA, Boyd K, Gunn J, Iqbal J, MacLullich A, Shenkin SD, Fox KAA, Mills N, Denvir MA. Frailty assessment and risk prediction by GRACE score in older patients with acute myocardial infarction. BMC Geriatr. 2020 Mar 13;20(1):102. doi: 10.1186/s12877-020-1500-9.

  PMID: 32164580 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Martin A Denvir, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: August 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

GB (1)