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ADRENAL Consent Substudy

ANZICS CTG Endorsed Study

ADRENAL Consent Substudy

A multicentre, prospective, observational study of the process of obtaining consent from potential participants or their substitute decision-makers in the adjunctive corticosteroid treatment in critically ill patients with septic shock (ADRENAL) Study

Study Description

The ADRENAL Consent Study is a multicentre, prospective, observational study which aims to describe the process through which written informed consent is sought from potential participants or their substitute decision-makers for the adjunctive corticosteroid treatment in critically ill patients with septic shock (ADRENAL) Study. The ADRENAL study is a randomised controlled trial of the effect of hydrocortisone on mortality in critically ill patients with septic shock.

Aims:

  1. To describe the rates of consent for enrolment and continued participation in the ADRENAL Study.
  2. To describe professional characteristics of the person seeking consent and the contextual features of the consent encounter, including coenrolment and readability of the information and consent form.
  3. To determine the time required by research coordinators to obtain a consent decision from potential ADRENAL participants or their substitute decision-makers.

Management Committee

Heidi Buhr (Chair), Deborah Cook, David Gattas, Julie Potter, Dorrilyn Rajbhandari, Kelly Thompson, Bala Venkatesh and Leonie Weisbrodt.

Funding

Intensive Care Foundation $5,000

Project Status as of June 2018

Data analysis in progress.

Reference

CTG 1213‐003

Contact

Heidi Buhr (email)