Clinical trial NCT06588101: Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU
Official title: Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Members
Recruitment
Clinical Study
Retention
Recruitment of Participants
Study Enrollment
Retention of Participants
Compensation Incentives
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 Design for randomization strategies 2x2 Desgin for retention strategies
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Recruitment percentage
timeFrame: At enrolment
measure: Retention percentage
timeFrame: From enrolment until 6 month follow-up completion
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute, McGill University, Jewish General Hospital
name: Michael J Goldfarb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: