Recruitment Strategies for Family Members in the ICU

(SWAT Trial)

Overseen By Jillian Kifell, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Another family member, repeat admissions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for Recruitment Strategies for Family Members in the ICU?

Research shows that using audiovisual modules and bundled consent processes can improve understanding and satisfaction with the informed consent process in the ICU, suggesting these strategies may be effective in recruiting family members by enhancing communication and clarity. ^{1 2 3 4 5}

Is the consent process in ICU research safe for participants?

The research does not provide specific safety data about the consent process itself, but it focuses on improving communication and understanding for family members, which suggests a focus on participant well-being. ^{1 2 3 4 6}

How does this treatment differ from other treatments for family members in the ICU?

This treatment is unique because it focuses on improving communication and satisfaction for family members of ICU patients through a 'bundled' consent process during early family meetings, rather than directly treating a medical condition. This approach is novel as it addresses the emotional and informational needs of families, which is not typically the focus of standard ICU treatments. ^{2 4 6 7 8}

What is the purpose of this trial?

There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit (ICU) patients. The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies (2 recruitment and 2 retention) will be tested. Investigators will integrate the strategies into three existing studies that involve family members of ICU patients. Participants will be randomized using a 2x2 factorial design. The co-primary outcomes are recruitment percentage (participants enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).

Research Team

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Eligibility Criteria

This trial is for family members of ICU patients. It's designed to test ways to get more people involved and keep them in clinical studies. To join, participants must be related to an ICU patient currently enrolled in one of the three existing studies.

Inclusion Criteria

I can communicate in English or French.

Expected hospital stay > 48 hours

Has family member admitted to an intensive care unit

Exclusion Criteria

Has another family member participating in the trial

Repeat admissions within the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Retention Strategy Evaluation

Participants are randomized to evaluate recruitment and retention strategies using a 2x2 factorial design

6 months

Follow-up

Participants are monitored for recruitment and retention outcomes

6 months

Treatment Details

Interventions

• Compensation
• Written informed consent with infographic

Trial Overview The study tests four different strategies: two aimed at recruiting family members into trials and two focused on keeping them until the end. Participants will be randomly assigned a combination of these strategies using a special design called '2x2 factorial'.

Participant Groups

Group I: One recruitment strategy - Infographic Experimental Treatment 1 Intervention

Consent form with Infographic + No compensation

Group II: One recruitment strategy - Compensation Experimental Treatment 1 Intervention

Consent form + Large compensation

Group III: Both recruitment strategies Experimental Treatment 2 Interventions

Consent form with Infographic + Large compensation

Group IV: Neither recruitment strategy Active Control 1 Intervention

Consent form + No compensation

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A review of 48 Canadian-led ICU/PICU randomized controlled trials involving 17,558 patients found that while most studies (90%) used prior informed consent, alternate consent models are becoming more common, with a notable increase in their use from 2000 to 2019.

The consent rates varied significantly, with prior informed consent yielding rates between 54-91% in ICU and 43-94% in PICU, while trials using alternate consent models had higher rates of 78-100% in ICU and 74-87% in PICU, indicating that these models may enhance participant engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consent models in Canadian critical care randomized controlled trials: a scoping review. O'Hearn, K., Gibson, J., Krewulak, K., et al.[2022]

The invasiveness of a study did not affect who patients and relatives preferred to give consent for ICU research, but it did increase the desire for multiple consent givers and decreased acceptance of deferred or two-step consent.

A significant portion of respondents (up to 31%) preferred someone other than the patient to provide consent, even when the patient was conscious, indicating a reluctance to take on the responsibility of consent alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICU research: the impact of invasiveness on informed consent. Gigon, F., Merlani, P., Chenaud, C., et al.[2021]

An audiovisual module designed to explain eight common ICU procedures showed a significant improvement in knowledge among patients and caregivers without a healthcare background, with scores increasing from 7.7 to 8.3 out of 11 questions.

Overall, 75% of participants found the video easy to understand, and 70% felt it enhanced their comprehension of ICU procedures, suggesting that such educational tools can effectively support informed consent in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study. Loftus, TJ., Alfaro, ME., Anderson, TN., et al.[2022]

Introducing a bundled informed consent process in the ICU significantly improved family satisfaction scores, with an average FS-ICU score of 95.4 in the intervention group compared to 78.2 in the control group (P<.001).

Nursing staff also reported higher satisfaction levels with care in the intervention group, indicating that improved communication and understanding of ICU procedures positively impacted both families and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of using a "bundled" consent for intensive care unit procedures as part of an early family meeting. Dhillon, A., Tardini, F., Bittner, E., et al.[2018]

The study highlights that key factors like information, understanding, and involvement in decision-making significantly influence patient satisfaction with the informed consent process in the ICU, based on a large database of patient feedback.

Providing specific information about advance directives, patient rights, and organ donation greatly enhances patient evaluations of the informed consent process, indicating that these elements are highly valued by ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive care patients' evaluations of the informed consent process. Clark, PA.[2015]

A study involving 96 substitute decision makers (SDMs) revealed that those who consented to research participation in the ICU were primarily motivated by the belief that research could help others and contribute to medical progress, with 91% citing potential benefits for others as a key reason.

Conversely, SDMs who declined participation often felt too anxious to consider research and expressed concerns about the risks and potential for experimental treatments, indicating that emotional state and fear of harm significantly influence their decision-making process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Mehta, S., Quittnat Pelletier, F., Brown, M., et al.[2021]

A study involving 1409 participants, including ICU patients, their relatives, and healthcare practitioners, revealed that most stakeholders support the idea of relatives acting as substitute decision makers (SDMs) for critically ill patients in research, as they are perceived to understand the patient's wishes well.

Participants expressed a strong desire for reassurance that patient care would take priority over research recruitment, highlighting the need for clear communication about the safeguards in place to protect patients during the consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study. Paddock, K., Woolfall, K., Kearney, A., et al.[2022]

In a study involving 38 patients scheduled for elective cardiac surgery, 22% were unaware they had participated in a research study, and 25% could not recall its purpose or risks, highlighting potential issues with informed consent in ICU settings.

Patients who did not remember their participation had longer ICU stays, suggesting that better communication and repeated information about study involvement may be necessary for ethical research practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed consent for research in ICU obtained before ICU admission. Chenaud, C., Merlani, P., Ricou, B.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Consent models in Canadian critical care randomized controlled trials: a scoping review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

ICU research: the impact of invasiveness on informed consent. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Benefit of using a "bundled" consent for intensive care unit procedures as part of an early family meeting. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Intensive care patients' evaluations of the informed consent process. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Informed consent for research in ICU obtained before ICU admission. [2018]