A study to improve communication between clinicians and patients with advanced heart failure: methods and challenges behind the working to improve discussions about defibrillator management trial.
We report the challenges of the Working to Improve Discussions About Defibrillator Management trial, our novel, multicenter trial aimed at improving communication between cardiology clinicians and their patients with advanced heart failure (HF) who have implantable cardioverter defibrillators (ICDs). The study objectives are (1) to increase ICD deactivation conversations, (2) to increase the number of ICDs deactivated, and (3) to improve psychological outcomes in bereaved caregivers. The unit of randomization is the hospital, the intervention is aimed at HF clinicians, and the patient and caregiver are the units of analysis. Three hospitals were randomized to usual care and three to intervention. The intervention consists of an interactive educational session, clinician reminders, and individualized feedback. We enroll patients with advanced HF and their caregivers, and then we regularly survey them to evaluate whether the intervention has improved communication between them and their HF providers. We encountered three implementation barriers. First, there were institutional review board concerns at two sites because of the palliative nature of the study. Second, we had difficulty in creating entry criteria that accurately identified an HF population at high risk of dying. Third, we had to adapt our entry criteria to the changing landscape of ventricular assist devices and cardiac transplant eligibility. Here we present our novel solutions to the difficulties we encountered. Our work has the ability to enhance conduct of future studies focusing on improving care for patients with advanced illness.
Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA; James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA. Electronic address: nathan.goldstein@mssm.edu.
Nathan E
NE
Goldstein
Division of Cardiology, Samuel Bronfman Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jill
J
Kalman
Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Jean S
JS
Kutner
Departments of Medicine, Radiation Medicine, and Nursing, Oregon Health Sciences University, Portland, Oregon, USA.
Erik K
EK
Fromme
Cardiovascular Division, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Mathew D
MD
Hutchinson
Divisions of Geriatrics and Cardiology, Montefiore Medical Center, Bronx, New York, USA; The Montefiore-Einstein Center for Bioethics, Montefiore Medical Center, Bronx, New York, USA.
Hannah I
HI
Lipman
Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Daniel D
DD
Matlock
Division of General Internal Medicine, Department of Medicine, Section of Palliative Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Keith M
KM
Swetz
Section of Cardiology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Rachel
R
Lampert
Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Omarys
O
Herasme
Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA; James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.
R Sean
RS
Morrison
D001601:Bereavement; D017028:Caregivers / Q000523:psychology; D003142:Communication; D017147:Defibrillators, Implantable; D028744:Ethics Committees, Research; D006333:Heart Failure / Q000628:therapy*; D006761:Hospitals; D006801:Humans; D010166:Palliative Care / Q000379:methods*; D010817:Physician-Patient Relations
Heart failure; IRB; communication; intervention; methods; palliative care; randomized controlled trial