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

Last updated: December 18, 2024
Sponsor: Lady Davis Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Written informed consent with infographic

Compensation

Clinical Study ID

NCT06588101
2024-4023
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has family member admitted to an intensive care unit.

  • Expected hospital stay > 48 hours

  • Able to participate in English or French

Exclusion

Exclusion Criteria:

  • Has another family member participating in the trial

  • Repeat admissions within the study period

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Written informed consent with infographic
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Jewish General Hospital

    Montreal, Quebec
    Canada

    Active - Recruiting

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