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

Not Applicable

Recruiting

• Conditions: Family Members; Recruitment; Clinical Study; Retention; Recruitment of Participants; Study Enrollment; Retention of Participants; Compensation Incentives
• Interventions: Other: Written informed consent with infographic; Other: Compensation

• Registration Number: NCT06588101
• Lead Sponsor: Lady Davis Institute

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.

Study Timeline

• Study First Submitted: 2024-04-19
• Study Start: 2024-05-01
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Both recruitment strategies	Written informed consent with infographic	Consent form with Infographic + Large compensation
Both recruitment strategies	Compensation	Consent form with Infographic + Large compensation
One recruitment strategy - Infographic	Written informed consent with infographic	Consent form with Infographic + No compensation
One recruitment strategy - Compensation	Compensation	Consent form + Large compensation

Primary Outcome Measures

Name	Time	Method
Recruitment percentage	At enrolment	Family member participants enrolled/ family member participants approached
Retention percentage	From enrolment until 6 month follow-up completion	Family member participant completing follow-up/family member participants enrolled

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada