Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial
Orla M Smith, Ellen McDonald, Nicole Zytaruk, Denise Foster, Andrea Matte, France Clarke, Suzie Fleury, Katie Krause, Tracey McArdle, Yoanna Skrobik, Deborah J Cook, Orla M Smith, Ellen McDonald, Nicole Zytaruk, Denise Foster, Andrea Matte, France Clarke, Suzie Fleury, Katie Krause, Tracey McArdle, Yoanna Skrobik, Deborah J Cook
Abstract
Background: Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers.
Objective: To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143).
Methods: 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively.
Results: We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies).
Conclusion: We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies.
Keywords: Clinical research; Critical care; Informed consent; Intensive care; Randomized trials; Studies; Substitute decision-makers.
Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed