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The Approach Study

NCT01232621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2013-01-07

No results posted yet for this study

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. The investigators will randomize SDMs of critically ill patients who are eligible to participate in any research study in operation to either 'physician introduction' of the research team or 'non-physician approach (non-physician)' in which research coordinators are introduced by allied health care team members or introduce themselves directly to SDMs. This study seeks to identify important features of the 'consent to research' process that can be modified to enhance both SDM satisfaction with the consent process and recruitment into critical care research studies.

Conditions

  • Critical Care Trial Participation Consent by SDM

Interventions

OTHER

Physician Introduction of research personnel

Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Karen EA Burns, MD, FRCPC, MSc (Epid) · St. Michael's Hospital, Toronto and the Keenan Research Centre/Li Ka Shing Knowledge Institute (Toronto)

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232621 on ClinicalTrials.gov