A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Feasibility Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SDMs of critically ill adults who are eligible (meet all inclusion criteria and have no
排除标准
- •) 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)
研究组 & 干预措施
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.
干预措施: Physician Introduction of research personnel (Other)
Non-physician introduction (usual approach)
RCs will either introduce themselves or be introduced by a non-physician member of the health care team.
干预措施: Physician Introduction of research personnel (Other)
结局指标
主要结局
Feasibility Outcome
时间窗: 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.
次要结局
- Consent Obtained Vs Consent Declined(7 days)