Better Research Interactions for Every Family (BRIEF)

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.

Study Overview

• Status: Completed
• Conditions: Trust; Respect; Study Enrollment
• Intervention / Treatment: Behavioral: BRIEF Educational Module

Detailed Description

The BRIEF Intervention will test the hypothesis that an evidence-based, researcher-facing educational module will improve the enrollment process for eligible families and increase diversity of populations enrolled in research. These in turn will improve the generalizability of neonatal clinical trials. The BRIEF Intervention is an educational module based on data about how research teams can approach families about research in a more equitable and respectful manner. The intervention will be implemented approximately halfway through DIVI study recruitment. The BRIEF team will measure outcomes, comparing before versus after the BRIEF Intervention is implemented, across three groups of participants:

1. Neonates eligible for participation in the DIVI study, identified through the records of the DIVI team. Research activities for this group are limited to extraction of targeted demographic and clinical data from the medical record by the BRIEF study team.
2. Parents/legally authorized representatives (LARs) of infants approached for the DIVI study who will be invited to take a survey about their experience being approached for the DIVI study, including questions about perceived respect and a validated scale to measure trust in medical researchers. Those who enroll in DIVI as well as those who decline to enroll in DIVI will be eligible to take the survey. The survey will also give them an opportunity to opt in to potentially be contacted for an interview, in which they will be asked open-ended questions about their experience being approached for the DIVI study.
3. DIVI study team members involved in recruitment. At or near the start of the DIVI study, the BRIEF team will obtain a list of contact information for each member of the DIVI team who will be involved in recruitment. The BRIEF team will contact each person individually to review and sign the BRIEF study consent form. The DIVI team will be asked to participate in the BRIEF educational module, which includes asynchronous and synchronous components, complete brief self-assessments of their consent discussions with families both before and after the intervention, and audio-record a subset of DIVI consent discussions so that the BRIEF team can assess fidelity to intervention components.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.
Experimental: BRIEF Arm; Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Enrollment Rates	The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.	Control Arm was assessed from baseline to the date of the intervention (pre-intervention) and the BRIEF Arm was assessed post-intervention to study completion (post-intervention), estimated at 14 months total (October 2022-December 2023).
Patient Trust in Research	The BRIEF team will compare parent/LAR-reported trust in research before vs. after implementation of the BRIEF intervention, using the validated 4-Item Trust in Medical Researchers scale described in Hall et al. 2008. Each item is scored on a 1-5 scale for a maximum score of 20 and a minimum score of 4, with higher scores indicating more trust. Scores are then indexed to a scale of 0-100, again with a higher rating indicating greater levels of trust.	Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).
Change in Patient Experiences of Respect During Research Recruitment	The BRIEF team will compare parent/LAR-reported experiences of being treated with respect during research recruitment before vs. after implementation of the BRIEF intervention. There is no relevant validated measure so this outcome will be measured using team-developed survey questions. Questions are measured on a Likert Scale, each item is scored on a 1-5 scale , with higher scores indicating greater perception of respect.	Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); University of Washington
• Investigators: Principal Investigator: Stephanie A Kraft, JD, Seattle Children's Hospital; Principal Investigator: Elliott M Weiss, MD, MSME, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: K01HG010361 (U.S. NIH Grant/Contract); K23HD103872 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No