Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU

NCT ID: NCT06588101

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Family Members; Recruitment; Clinical Study; Retention; Recruitment of Participants; Study Enrollment; Retention of Participants; Compensation Incentives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Both recruitment strategies

Consent form with Infographic + Large compensation

Group Type: EXPERIMENTAL

Written informed consent with infographic

Intervention Type: OTHER

Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.

Compensation

Intervention Type: OTHER

Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Neither recruitment strategy

Consent form + No compensation

Group Type: NO_INTERVENTION

No interventions assigned to this group

One recruitment strategy - Infographic

Consent form with Infographic + No compensation

Group Type: EXPERIMENTAL

Written informed consent with infographic

Intervention Type: OTHER

Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.

One recruitment strategy - Compensation

Consent form + Large compensation

Group Type: EXPERIMENTAL

Compensation

Intervention Type: OTHER

Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Interventions

Written informed consent with infographic

Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.

Intervention Type: OTHER

Compensation

Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Has family member admitted to an intensive care unit.
• Expected hospital stay > 48 hours
• Able to participate in English or French

Exclusion Criteria

• Has another family member participating in the trial
• Repeat admissions within the study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Michael Goldfarb

Attending Staff, Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Goldfarb, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Lady Davis Institute, McGill University, Jewish General Hospital

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jillian Kifell, MSc

Role: CONTACT

jillian.kifell.ccomtl@ssss.gouv.qc.ca

5143408222 ext. 25806

Facility Contacts

Jillian Kifell, MSc

Role: primary

jillian.kifell.ccomtl@ssss.gouv.qc.ca

5143408222 ext. 25806

Other Identifiers

2024-4023

Identifier Type: -

Identifier Source: org_study_id