The Approach Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01232621
First received: October 28, 2010
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Critical Care Trial Participation Consent by SDM
Other: Physician Introduction of research personnel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Feasibility Outcome [ Time Frame: 7 days ] [ Designated as safety issue: No ]

    Feasibility of the pilot study will be assessed by the following:

    1. We expect that (i) ≤ 15% of physician introductions will be missed due to lack of physician availability (physician introduction arm) and (ii) cross-overs (from either arm to the other) will occur in ≤ 15% on introductions.
    2. Following randomization, we expect that ≤ 20% of introductions will be missed due to inability of the RC to contact existing SDMs once identified (either intervention or control arm).
    3. We will obtain at least 70% of initial SDM questionnaires Part A and at least 50% of questionnaires Part B.


Secondary Outcome Measures:
  • Consent Obtained Vs Consent Declined [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    1. describe the proportion of SDMs providing and declining consent when approached by a RC or accompanied by the most responsible physician and when an update accompanies an introduction.
    2. determine the time interval between critically ill patients' meeting eligibility criteria and sentinel events.
    3. elucidate reasons why SDMs provide or decline consent
    4. assess agreement between SDMs, RCs and attending physicians acceptance of and comfort and satisfaction with the alternative approaches


Enrollment: 138
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physician introduction
Physicians will introduce Research Coordinators (RCs) by name to SDMs and acknowledge patient eligibility to participate in a study using a standardized script.
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.
Other Names:
  • Approach to Consent
  • Consent
  • Substitute Decision Maker
Active Comparator: Non-physician introduction (usual approach)
RCs will either introduce themselves or be introduced by a non-physician member of the health care team.
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.
Other Names:
  • Approach to Consent
  • Consent
  • Substitute Decision Maker

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232621

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Karen EA Burns, MD, FRCPC, MSc (Epid) St. Michael's Hospital, Toronto and the Keenan Research Centre/Li Ka Shing Knowledge Institute (Toronto)
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01232621     History of Changes
Other Study ID Numbers: 10-278
Study First Received: October 28, 2010
Last Updated: January 4, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 26, 2014