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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to involve family members of ICU patients in clinical studies. Researchers are testing four strategies to determine which ones encourage more participation and retention. The strategies include offering compensation and using an infographic to simplify consent forms (written informed consent with infographic). Family members of someone in the ICU for at least two days who can speak English or French may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to enhance patient and family involvement in critical care research.

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 prior data suggests that these recruitment and retention strategies are safe for family members of ICU patients?

This study tests two methods to encourage participation: using infographics and offering compensation.

Research has shown that infographics help people better understand research studies by simplifying complex information. This makes it easier for participants and their families to grasp what the trial involves.

Compensation involves offering money to participants. Studies have found that about half of the family members of ICU patients asked to join trials participated, and more than 80% remained involved through the first follow-up. This suggests that compensation might encourage more people to join and stay in the study.

Both strategies have been used in other contexts without major safety issues, indicating they are generally well-received. Since they are not medical treatments, the focus is on how well they improve participation in the trial, rather than safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve recruitment strategies in the ICU setting. Traditional approaches often involve standard consent forms with no incentives. This trial investigates the impact of using an infographic to make the consent process clearer and more engaging, as well as offering financial compensation to boost participation. By testing these strategies, researchers hope to find more effective methods to involve family members in critical healthcare decisions, potentially leading to better patient outcomes and more inclusive studies.

What evidence suggests that this trial's strategies could be effective for recruiting and retaining family members of ICU patients?

This trial will evaluate different recruitment strategies for family members of ICU patients. One strategy involves offering compensation, which studies have shown can encourage more family members to join trials, with about half of those asked choosing to participate and over 80% completing the first follow-up. Another strategy being tested uses an infographic to explain the consent form. Research shows that this approach makes the information clearer and more engaging, helping families understand the research and their options better. Some participants in this trial will experience both strategies, while others will experience one or neither. Together, these strategies aim to increase the number of participants who join and stay in clinical trials, making the research more effective and efficient. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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'.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11199003/

Recruitment and Retention Strategies for Randomized ... This review found that half of family members of ICU patients approached participated in trials and more than 80% completed the initial follow-up visit.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06588101

Study Details | NCT06588101 | Clinical Trial Recruitment ... The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting.

3. journals.lww.com journals.lww.com/ccejournal/fulltext/2024/07000/recruitment_and_retention_strategies_for.5.aspx

Recruitment and Retention Strategies for Randomized... Findings: This review found that half of family members of ICU patients approached participated in trials and more than 80% completed the initial follow-up ...

4. withpower.com withpower.com/trial/phase-recruitment-4-2024-486fc

Recruitment Strategies for Family Members in the ICU The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1036731425000621

Recruitment and retention of intensive care unit survivors in ... Outcome data included study retention rates, timing and type of recruitment strategies, retention strategies, retention challenges, and reasons cited for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12415862/

Family Support Strategies During Intensive Care Unit The most common relationship to ICU patients was that of a spouse—28.69% in the intervention group and 35.81% in the control group—followed ...