At a glance
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A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study
In Brief
A Phase 2 clinical trial evaluating Physician Introduction of research personnel for Critical Care Trial Participation Consent by SDM. Completed, enrolled 138 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script.