Trial Outcomes & Findings for Better Research Interactions for Every Family (NCT NCT04152603)

Last Updated: 2024-03-28

Results Overview

The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

138 participants

Primary outcome timeframe

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).

Results posted on

2024-03-28

Participant Flow

Recruitment started on October 10, 2022 and ended on December 31, 2023. All recruitment took place remotely.

Given the pre-post design of the study, participants were not pre-assigned to the control or BRIEF arm. Rather, assignment was based on the date of a participant's enrollment. Participants excluded from the study are limited to those not eligible for the partner clinical trial (DIVI study).

Participant milestones

Participant milestones
Measure	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.	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. 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).	DIVI Study Team Group consists of the partner study team members who received the BRIEF training. 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).
Overall Study STARTED	52	77	9
Overall Study Neonates	33	56	0
Overall Study Parents/LARs	19	21	0
Overall Study COMPLETED	52	77	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Each row represents a subset of the overall population. Neonate age data not collected and analyzed.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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).

Population: Number of BRIEF participants across the Control and BRIEF arms that either enrolled in the DIVI study or did not enroll in the DIVI study (neonates only).

The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.

Outcome measures

Outcome measures
Measure	BRIEF Arm n=56 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. 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).	Control Arm n=33 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.
Study Enrollment Rates Enrolled in DIVI	24 Participants	13 Participants
Study Enrollment Rates Not Enrolled in DIVI	32 Participants	20 Participants

PRIMARY outcome

Timeframe: 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).

Population: Parents/LARs only.

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.

Outcome measures

Outcome measures
Measure	BRIEF Arm n=21 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. 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).	Control Arm n=19 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.
Patient Trust in Research	77 score on a scale Standard Deviation 11	78 score on a scale Standard Deviation 18

PRIMARY outcome

Timeframe: 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).

Population: Parents/LARs only.

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.

Outcome measures

Outcome measures
Measure	BRIEF Arm n=21 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. 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).	Control Arm n=19 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.
Change in Patient Experiences of Respect During Research Recruitment	4.76 score on a scale Interval 4.0 to 5.0	4.36 score on a scale Interval 2.0 to 5.0

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BRIEF Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Stephanie Kraft

Seattle Children's Research Institute

Phone: 20688471022068841191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Arm n=52 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.	BRIEF Arm n=77 Participants Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. 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).	DIVI Study Team n=9 Participants Group consists of the partner study team members who received the BRIEF training. 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).	Total n=138 Participants Total of all reporting groups
Age, Continuous Parents/LARs	31 Years n=19 Participants • Each row represents a subset of the overall population. Neonate age data not collected and analyzed.	34 Years n=21 Participants • Each row represents a subset of the overall population. Neonate age data not collected and analyzed.	—	32 Years n=40 Participants • Each row represents a subset of the overall population. Neonate age data not collected and analyzed.
Age, Continuous DIVI Team	—	—	44 Years n=9 Participants • Each row represents a subset of the overall population. Neonate age data not collected and analyzed.	44 Years n=9 Participants • Each row represents a subset of the overall population. Neonate age data not collected and analyzed.
Sex/Gender, Customized Neonates · Female	15 Participants n=33 Participants • Each row represents a subset of the overall population.	19 Participants n=56 Participants • Each row represents a subset of the overall population.	—	34 Participants n=89 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized Neonates · Male	18 Participants n=33 Participants • Each row represents a subset of the overall population.	31 Participants n=56 Participants • Each row represents a subset of the overall population.	—	49 Participants n=89 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized Neonates · Unknown	0 Participants n=33 Participants • Each row represents a subset of the overall population.	6 Participants n=56 Participants • Each row represents a subset of the overall population.	—	6 Participants n=89 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized Parents/LARs · Female	11 Participants n=19 Participants • Each row represents a subset of the overall population.	15 Participants n=21 Participants • Each row represents a subset of the overall population.	—	26 Participants n=40 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized Parents/LARs · Male	8 Participants n=19 Participants • Each row represents a subset of the overall population.	5 Participants n=21 Participants • Each row represents a subset of the overall population.	—	13 Participants n=40 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized Parents/LARs · Unknown	0 Participants n=19 Participants • Each row represents a subset of the overall population.	1 Participants n=21 Participants • Each row represents a subset of the overall population.	—	1 Participants n=40 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized DIVI Team · Female	—	—	5 Participants n=9 Participants • Each row represents a subset of the overall population.	5 Participants n=9 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized DIVI Team · Male	—	—	3 Participants n=9 Participants • Each row represents a subset of the overall population.	3 Participants n=9 Participants • Each row represents a subset of the overall population.
Sex/Gender, Customized DIVI Team · Unknown	—	—	1 Participants n=9 Participants • Each row represents a subset of the overall population.	1 Participants n=9 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Neonates · Hispanic or Latino	5 Participants n=33 Participants • Each row represents a subset of the overall population.	13 Participants n=56 Participants • Each row represents a subset of the overall population.	—	18 Participants n=89 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Neonates · Not Hispanic or Latino	27 Participants n=33 Participants • Each row represents a subset of the overall population.	34 Participants n=56 Participants • Each row represents a subset of the overall population.	—	61 Participants n=89 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Neonates · Unknown or Not Reported	1 Participants n=33 Participants • Each row represents a subset of the overall population.	9 Participants n=56 Participants • Each row represents a subset of the overall population.	—	10 Participants n=89 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Parents/LARs · Hispanic or Latino	7 Participants n=19 Participants • Each row represents a subset of the overall population.	7 Participants n=21 Participants • Each row represents a subset of the overall population.	—	14 Participants n=40 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Parents/LARs · Not Hispanic or Latino	12 Participants n=19 Participants • Each row represents a subset of the overall population.	13 Participants n=21 Participants • Each row represents a subset of the overall population.	—	25 Participants n=40 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) Parents/LARs · Unknown or Not Reported	0 Participants n=19 Participants • Each row represents a subset of the overall population.	1 Participants n=21 Participants • Each row represents a subset of the overall population.	—	1 Participants n=40 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) DIVI Team · Hispanic or Latino	—	—	1 Participants n=9 Participants • Each row represents a subset of the overall population.	1 Participants n=9 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) DIVI Team · Not Hispanic or Latino	—	—	8 Participants n=9 Participants • Each row represents a subset of the overall population.	8 Participants n=9 Participants • Each row represents a subset of the overall population.
Ethnicity (NIH/OMB) DIVI Team · Unknown or Not Reported	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · American Indian or Alaska Native	1 Participants n=33 Participants • Each row represents a subset of the overall population.	4 Participants n=56 Participants • Each row represents a subset of the overall population.	—	5 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · Asian	0 Participants n=33 Participants • Each row represents a subset of the overall population.	7 Participants n=56 Participants • Each row represents a subset of the overall population.	—	7 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · Native Hawaiian or Other Pacific Islander	1 Participants n=33 Participants • Each row represents a subset of the overall population.	0 Participants n=56 Participants • Each row represents a subset of the overall population.	—	1 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · Black or African American	6 Participants n=33 Participants • Each row represents a subset of the overall population.	12 Participants n=56 Participants • Each row represents a subset of the overall population.	—	18 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · White	24 Participants n=33 Participants • Each row represents a subset of the overall population.	20 Participants n=56 Participants • Each row represents a subset of the overall population.	—	44 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · More than one race	1 Participants n=33 Participants • Each row represents a subset of the overall population.	1 Participants n=56 Participants • Each row represents a subset of the overall population.	—	2 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Neonates · Unknown or Not Reported	0 Participants n=33 Participants • Each row represents a subset of the overall population.	12 Participants n=56 Participants • Each row represents a subset of the overall population.	—	12 Participants n=89 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · American Indian or Alaska Native	0 Participants n=19 Participants • Each row represents a subset of the overall population.	1 Participants n=21 Participants • Each row represents a subset of the overall population.	—	1 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · Asian	0 Participants n=19 Participants • Each row represents a subset of the overall population.	1 Participants n=21 Participants • Each row represents a subset of the overall population.	—	1 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · Native Hawaiian or Other Pacific Islander	1 Participants n=19 Participants • Each row represents a subset of the overall population.	0 Participants n=21 Participants • Each row represents a subset of the overall population.	—	1 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · Black or African American	1 Participants n=19 Participants • Each row represents a subset of the overall population.	2 Participants n=21 Participants • Each row represents a subset of the overall population.	—	3 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · White	16 Participants n=19 Participants • Each row represents a subset of the overall population.	11 Participants n=21 Participants • Each row represents a subset of the overall population.	—	27 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · More than one race	1 Participants n=19 Participants • Each row represents a subset of the overall population.	1 Participants n=21 Participants • Each row represents a subset of the overall population.	—	2 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) Parents/LARs · Unknown or Not Reported	0 Participants n=19 Participants • Each row represents a subset of the overall population.	5 Participants n=21 Participants • Each row represents a subset of the overall population.	—	5 Participants n=40 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · American Indian or Alaska Native	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · Asian	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · Black or African American	—	—	1 Participants n=9 Participants • Each row represents a subset of the overall population.	1 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · White	—	—	8 Participants n=9 Participants • Each row represents a subset of the overall population.	8 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · More than one race	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.
Race (NIH/OMB) DIVI Team · Unknown or Not Reported	—	—	0 Participants n=9 Participants • Each row represents a subset of the overall population.	0 Participants n=9 Participants • Each row represents a subset of the overall population.