Family MembersSWATNCT06588101
Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU
A study testing Written informed consent with infographic and Compensation in people with Family Members and Recruitment, run by Lady Davis Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Members, Recruitment, Clinical Study
- What is being tested?
- Written informed consent with infographic and Compensation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has family member admitted to an intensive care unit.
- Expected hospital stay > 48 hours
- Able to participate in English or French
Who cannot join
- Has another family member participating in the trial
- Repeat admissions within the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec
Jillian Kifell, MSc, 5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
About this study
Official title: Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design
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).
Read the detailed description
Family engagement in the ICU is recommended by critical care professional societies, but insufficient evidence of its benefits for patients and family members has hindered clinical uptake. Thus, high-quality evidence is needed to promote and support family engagement practices. A specific unmet need is to identify strategies to improve the recruitment and retention of families in clinical trials in the ICU setting. The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting.
Methodological Approach: Investigators will use a Study Within a Trial (SWAT) design to embed a factorial randomized trial of 160 participants enrolled across investigator group's three ongoing studies involving family members of ICU patients: FAME, VR-Family, and NGAGE. Investigators expect 160 participants to be enrolled over a 6-month period. Participants will be randomized by 2x2 factorial design to selected recruitment and/or retention strategies. The co-primary outcomes will be (1) recruitment rate and (2) retention rate.
- Conditions
- Family Members, Recruitment, Clinical Study, Retention, Recruitment of Participants, Study Enrollment
- Being tested
- Written informed consent with infographic, Compensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written informed consent with infographicOther
Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.
CompensationOther
Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Both recruitment strategies | Experimental | Consent form with Infographic + Large compensation Receives: Other: Written informed consent with infographic; Other: Compensation |
| Neither recruitment strategy | No intervention | Consent form + No compensation |
| One recruitment strategy - Infographic | Experimental | Consent form with Infographic + No compensation Receives: Other: Written informed consent with infographic |
| One recruitment strategy - Compensation | Experimental | Consent form + Large compensation Receives: Other: Compensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment percentage
Family member participants enrolled/ family member participants approached
Measured: At enrolment
Retention percentage
Family member participant completing follow-up/family member participants enrolled
Measured: From enrolment until 6 month follow-up completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Design for randomization strategies 2x2 Desgin for retention strategies
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
- Investigators
- Michael J Goldfarb, MD, MSc, Principal investigator, Lady Davis Institute, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588101
- Sponsor's protocol ID
- 2024-4023
- Acronym
- SWAT
- Status last verified
- May 2025
- First submitted
- 19 Apr 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design
- ClinicalTrials.gov ID
- NCT06588101
- Acronym / sponsor ID
- SWAT / 2024-4023
- Conditions
- Family Members, Recruitment, Clinical Study, Retention, Recruitment of Participants, Study Enrollment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Family engagement in the ICU is recommended by critical care professional societies, but insufficient evidence of its benefits for patients and family members has hindered clinical uptake. Thus, high-quality evidence is needed to promote and support family engagement practices. A specific unmet need is to identify strategies to improve the recruitment and retention of families in clinical trials in the ICU setting. The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting.
Methodological Approach: Investigators will use a Study Within a Trial (SWAT) design to embed a factorial randomized trial of 160 participants enrolled across investigator group's three ongoing studies involving family members of ICU patients: FAME, VR-Family, and NGAGE. Investigators expect 160 participants to be enrolled over a 6-month period. Participants will be randomized by 2x2 factorial design to selected recruitment and/or retention strategies. The co-primary outcomes will be (1) recruitment rate and (2) retention rate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 Design for randomization strategies 2x2 Desgin for retention strategies
| Arm | Type | Receives |
|---|---|---|
| Both recruitment strategies | Experimental | Other: Written informed consent with infographic, Other: CompensationConsent form with Infographic + Large compensation |
| Neither recruitment strategy | No intervention | –Consent form + No compensation |
| One recruitment strategy - Infographic | Experimental | Other: Written informed consent with infographicConsent form with Infographic + No compensation |
| One recruitment strategy - Compensation | Experimental | Other: CompensationConsent form + Large compensation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has family member admitted to an intensive care unit.
- Expected hospital stay > 48 hours
- Able to participate in English or French
Key exclusion criteria (2 listed)
- Has another family member participating in the trial
- Repeat admissions within the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written informed consent with infographicPotential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form. | Other | Both recruitment strategies, One recruitment strategy - Infographic |
| CompensationPotential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire. | Other | Both recruitment strategies, One recruitment strategy - Compensation |
Primary outcome
Recruitment percentage
Time frame: At enrolment
Family member participants enrolled/ family member participants approached
Retention percentage
Time frame: From enrolment until 6 month follow-up completion
Family member participant completing follow-up/family member participants enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Goldfarb, MD, MSc principal investigator
Lady Davis Institute, McGill University, Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written informed consent with infographic and Compensation in people with Family Members and Recruitment, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian Kifell, MSc (5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment percentage (time frame: At enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.