The Deferred Consent Model in A Low Risk Study Evaluating Myocardial Injury in the ICU
CCCF ePoster library. Honarmand K. Oct 28, 2015; 114771; P117 Disclosure(s): This study was funded by generous grants provided by Physician Services Incorporated and Hamilton Health Sciences.
Dr. Kimia Honarmand
Dr. Kimia Honarmand
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Abstract
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P117


Topic: Retrospective or Prospective Cohort Study


The Deferred Consent Model in A Low Risk Study Evaluating Myocardial Injury in the ICU



Kimia Honarmand, D. Ulic, E. Belley-Cote, A. Khalifa, A. Gibson, G. McClure, N. Savija, F. Alshamsi, F. D'Aragon, B. Rochwerg, E. Duan, T. Karachi, R. Whitlock, D. Cook

Internal Medicine, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Critical Care and Clinical Epidemiology, McMaster University, Hamilton, Canada | Internal Medicine, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Canada | Population Health Research Institute, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada | Cardiac Surgery, McMaster University, Hamilton, Canada | Critical Care, McMaster University, Hamilton, Canada

Introduction:

Informed consent is a hallmark of ethical clinical research. An inherent challenge in critical care research is obtaining consent in the intensive care unit (ICU) when patients lack decision-making capacity. Substitute decision makers (SDMs) are often approached for consent, but this is limited by their availability and state of mind at the time the patient is admitted ICU. Deferred consent is a solution to this challenge.



Objectives:

The objective of this PRO-TROPICS sub-study is to describe a deferred consent model in a low-risk, minimally invasive study in the ICU.



Methods:

PRO-TROPICS was a prospective, pilot observational study of adult critically ill patients in 3 Hamilton ICUs, involving serial electrocardiograms and cardiac biomarkers during the ICU stay. Newly admitted ICU patients were enrolled over one month. When possible, informed consent was obtained a priori, but largely consent was deferred until investigators could approach the patient or their SDMs. Our local Research Ethics Board approved the study.



Results:

Of 266 patients approached, consent encounters were with patients (n=140, 52.6%) more often than SDMs (n=126, 47.4%), led mostly by residents following a brief training session. Consent encounters were in person (n=221, 83.1%) or by telephone (n=45, 16.9%). The overall consent rate was 80.1% (84.5% at St. Joseph’s Healthcare, 84.4% at the Juravinski Hospital, and 72.6% at the Hamilton General Hospital; p=0.07). The median interval between enrollment and the consent encounter was 1 day (IQR=1-2). There was no difference in consent rates between patients and SDMs (84.3% vs. 75.4%; p=0.09). Of 53 persons declining consent, 37 (69.8%) agreed to the use of data collected to that point.



Conclusion:

While informed consent should be obtained as early as possible, the deferred consent model facilitates timely protocol implementation until the consent encounter is possible. The deferred consent model appears to be a feasible alternative to exclusively a priori consent in low-risk ICU studies.



References: None.
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