Better Research Interactions for Every Family

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.

Conditions

• Respect
• Trust
• Study Enrollment

Interventions

BEHAVIORAL

BRIEF Educational Module

The BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min).

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Stephanie A Kraft, JD · Seattle Children's Hospital

• Elliott M Weiss, MD, MSME · Seattle Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-10

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• United States

Study Locations