Clinical trial NCT01232621: The Approach Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Care Trial Participation Consent by SDM
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility 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)

Primary outcomes:
measure: Feasibility Outcome
timeFrame: 7 days
Secondary outcomes:
measure: Consent Obtained Vs Consent Declined
timeFrame: 7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, Toronto and the Keenan Research Centre/Li Ka Shing Knowledge Institute (Toronto)
name: Karen EA Burns, MD, FRCPC, MSc (Epid)
role: PRINCIPAL_INVESTIGATOR
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