Use of a Trial Innovation Network (TIN) Recruitment Innovation Center (RIC) Survey to Improve Subject Recruitment and Enrollment in an Adolescent Concussion Study: CARE4Kids
Meeryo Choe1, Kelsee Meyerhoffer2, Christopher Miles3, Larry Cook2, Gerard Gioia4, Fred Rivara5, Christopher Giza6
1Pediatrics, UCLA Mattel Children's Hospital, 2Pediatrics, University of Utah, 3Wake Forest Baptist Health, 4Childrens National Hospital, 5Pediatrics, University of Washington, 6UCLA, Depts of Pediatrics and Neurosurgery
Objective:
To identify barriers and strategies to improve enrollment in multi-site pediatric and adolescent concussion studies.
Background:
The NINDS-funded CARE4Kids (C4K) Consortium (
https://www.care4kidsstudy.com/) is currently recruiting the first of two adolescent concussion cohorts (development, validation) to develop a clinical algorithm to predict those who will have prolonged recovery. However, enrollment in pediatric and adolescent concussion studies can be challenging. We hypothesized that utilizing the Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN) would help to target actionable challenges to recruitment and enhance subject engagement.
Design/Methods:
The C4K Consortium Recruitment and Retention Committee partnered with the TIN to develop a survey aimed at identifying roadblocks to subject enrollment and make recommendations. 60 parent/guardian child (ages 11-18yrs) dyads completed a survey through invitations sent to ResearchMatch volunteers. A survey vignette provided respondents with a general idea of C4K trial. 31 dyads ultimately responded, with one child’s responses excluded due to incompleteness.
Results:
For the first 39 week
s of subject recruitment, the average rate of consent was 1.7 subjects per week, with 1.5 subjects per week completing the first (T1) data collection point. Key findings of the survey included: 1)
parents/guardians felt increased compensation would be appropriate for travel costs & time spent at visits, 2) All parents/guardians wanted the study results shared with their child’s doctor. Over the course of 3 months, these results of the TIN RIC survey were implemented after IRB approval. In the second 30 weeks of subject recruitment, the average rate of consent was 3.4 subjects per week, with 2.8 subjects per week completing the T1 data point.
Conclusions:
Utilization of TIN resources and expertise were instrumental in nearly doubling the consent rate and completion of T1 data point for our development cohort. Early engagement with TIN in pediatric/adolescent studies can improve efficiency in study recruitment.