N/A
N=138
Better Research Interactions for Every Family
Respect · Trust · Study Enrollment
Bottom Line
View on ClinicalTrials.gov: NCT04152603 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Study Enrollment Rates — 13; 24; 20; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BRIEF Educational Module (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Enrollment Rates |
13; 24; 20; 32 | — |
| PRIMARY Patient Trust in Research |
78; 77 | — |
| PRIMARY Change in Patient Experiences of Respect During Research Recruitment |
4.36; 4.76 | — |
Summary
This is a study of the feasibility of implementing a modified recruitment approach, the Better Research Interactions for Every Family (BRIEF) Intervention, within a neonatal clinical trial. This intervention has two distinct aims: 1) improve the experience for parents asked to enroll their infant in a neonatal clinical trial; and 2) decrease disparities in enrollment within a neonatal clinical trial. The investigators will apply the BRIEF within a single site neonatal RCT, the Darbe plus IV Iron (DIVI) study, using a pre/post approach. The intervention will be implemented approximately halfway through recruitment for the DIVI study. The objectives of this study are to assess feasibility, gain preliminary experience to drive further refinement, and provide effect estimates for a future RCT of the BRIEF intervention.
Eligibility Criteria
Inclusion Criteria
- Neonates (born between 24-0 and 31-6 weeks of gestation) at the University of Washington Medical Center (UWMC) eligible for inclusion in the Darbe plus IV Iron (DIVI) study; OR
- Parents or legally authorized representatives (LARs) of neonates approached for participation in the DIVI study; OR
- Members of the DIVI research team involved in recruitment.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04152603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.