Status:
COMPLETED
The Approach Study
Lead Sponsor:
Unity Health Toronto
Conditions:
Critical Care Trial Participation Consent by SDM
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
In the Approach Study, the investigators will study the 'process' by which Substitute Decision Makers (SDMs) are approached for consent for their loved one's participation in critical care research. T...
Detailed Description
Rationale: Conduct of clinical research in the intensive care unit (ICU) presents challenges including the necessity to obtain consent for patients lacking decision-making capacity, operationalize res...
Eligibility Criteria
Inclusion
- SDMs of critically ill adults who are eligible (meet all inclusion criteria and have no exclusion criteria) to participate in a critical care research study in progress in the ICU
Exclusion
- Eligible critically ill adults who die or are transferred out of a participating ICU prior to being screened by a RC
- Critically ill adults capable of providing primary consent for research participation.
- We will limit participation to initial encounters (the same patient will not be included more than once)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01232621
Start Date
July 1 2011
End Date
November 1 2012
Last Update
January 7 2013
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8