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

Lady Davis Institute

Status: Enrolling

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

Treatments: Other: Compensation; Other: Written informed consent with infographic

Study type: Interventional

Funder types: Other

Identifiers

NCT06588101

2024-4023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Both recruitment strategies

Experimental group

Description:

Consent form with Infographic + Large compensation

Treatment:

Other: Written informed consent with infographic

Other: Compensation

Neither recruitment strategy

No Intervention group

Description:

Consent form + No compensation

One recruitment strategy - Infographic

Experimental group

Description:

Consent form with Infographic + No compensation

Treatment:

Other: Written informed consent with infographic

One recruitment strategy - Compensation

Experimental group

Description:

Consent form + Large compensation

Treatment:

Other: Compensation