The Approach Study

January 4, 2013 updated by: Unity Health Toronto

A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 research protocols under emergency conditions and investigate conditions with high mortality. Most critically ill patients are unable to comprehend or communicate and Substitute Decision Makers (SDMs) typically provide consent for their research participation. SDMs of critically ill patients may be overwhelmed by the patient's circumstances and the amount of medical information presented to them. Preliminary data suggest that SDMs prefer physician involvement in the consent process.

Primary Objective: To demonstrate the ability to implement a randomized controlled trial (RCT) evaluating two different approaches for introducing research coordinators (RC) to SDMs (physician introduction vs. non physician introduction) for participating in ICU research studies.

Secondary Objectives: To describe, among SDMs approached for consent to participate in an ICU research study by either physician or non-physician introduction (e.g., nurse, social worker)]: (a) the proportion of SDMs providing and declining consent, (b) the time between meeting eligibility criteria and sentinel events (being approached for consent, and either providing or declining consent), (c) reasons for SDMs providing or declining consent, and (d) agreement between questionnaires completed by SDMs and RCs and physicians regarding their acceptance of and comfort and satisfaction with the approach utilized.

Study Overview: We will conduct a multicentre pilot RCT of different methods (physician vs. non-physician introduction of research personnel) for approaching SDMs for consent for a loved one to participate in critical care research at 3 ICUs in Ontario.

Study Population: This study will focus on the approach to SDMs (n=99) 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 during the data collection period, and which requires SDM consent.

Interventions: In the intervention arm physicians will introduce RCs and study participation to SDMs using a standardized script. In the control arm RCs will either introduce themselves or be introduced by a non-physician member of the health care teams. RCs will complete an "Event Form" each time a critically ill adult is eligible to participate in a study. "Site Forms" and "Study Forms" will capture ICU-related information and studies in operation over the study period, respectively. We will administer 3 to 8 item questionnaires to SDMs, RCs and physicians involved in consent encounters to describe their acceptance of and comfort and satisfaction with the approach utilized.

Study Outcomes: To demonstrate the feasibility of an RCT evaluating 2 methods of approaching SDMs for consent for research participation. Feasibility will be defined as (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% of encounters. We will demonstrate that ≤ 20% of introductions (following randomization) will be missed due to inability of the research team to contact an identified SDM and at least 70% and 50% of initial and subsequent SDM questionnaires will be returned.

Relevance: The Approach Study will provide valuable information for stakeholders committed to ensuring the ethical basis of critical care research; and will guide the design of a larger RCT examining how to best approach SDMs of critically ill patients. Moreover it will provide insight on how to best approach SDMs to make encounters more comfortable, credible, informed and less burdensome for them. The Approach Study will provide the framework for a larger phase 3 study examining how to best approach SDMs.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcome
Time Frame: 7 days

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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consent Obtained Vs Consent Declined
Time Frame: 7 days
  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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 10-278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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