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

NCT06588101 | Recruiting

• 1 other identifier: 2024-4023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Recruitment percentage

  Family member participants enrolled/ family member participants approached

  At enrolment

• Retention percentage

  Family member participant completing follow-up/family member participants enrolled

  From enrolment until 6 month follow-up completion

Study Arms (4)

Both recruitment strategies

EXPERIMENTAL

Consent form with Infographic + Large compensation

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

Other: Written informed consent with infographic

One recruitment strategy - Compensation

EXPERIMENTAL

Consent form + Large compensation

Other: Compensation

Interventions

Written informed consent with infographic 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.

Both recruitment strategies; One recruitment strategy - Infographic

Compensation OTHER

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

Both recruitment strategies; One recruitment strategy - Compensation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lady Davis Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Interventions

Compensation and Redress

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Jurisprudence; Social Control, Formal

Study Officials

• Michael J Goldfarb, MD, MSc

  Lady Davis Institute, McGill University, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Kifell, MSc

CONTACT

5143408222; jillian.kifell.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Model Details: 2x2 Design for randomization strategies 2x2 Desgin for retention strategies

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)