Respect, Study Enrollment, Trust
Conditions
Brief 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.
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.
Interventions
BEHAVIORALBRIEF 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
University of Washington
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Enrollment Rates | 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). | The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention. |
| Patient Trust in Research | 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). | 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. |
| Change in Patient Experiences of Respect During Research Recruitment | 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). | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment started on October 10, 2022 and ended on December 31, 2023. All recruitment took place remotely.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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). | 77 |
| 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). | 9 |
| Total | 138 |
Baseline characteristics
| Characteristic | DIVI Study Team | Total | — | Control Arm | BRIEF Arm |
|---|---|---|---|---|---|
| Age, Continuous DIVI Team | 44 Years | 44 Years | — | — | — |
| Age, Continuous Neonates | — | — | — Years | — | — |
| Age, Continuous Parents/LARs | — | 32 Years | — | 31 Years | 34 Years |
| Ethnicity (NIH/OMB) DIVI Team Hispanic or Latino | 1 Participants | 1 Participants | — | — | — |
| Ethnicity (NIH/OMB) DIVI Team Not Hispanic or Latino | 8 Participants | 8 Participants | — | — | — |
| Ethnicity (NIH/OMB) DIVI Team Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Neonates Hispanic or Latino | — | 18 Participants | — | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Neonates Not Hispanic or Latino | — | 61 Participants | — | 27 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Neonates Unknown or Not Reported | — | 10 Participants | — | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Parents/LARs Hispanic or Latino | — | 14 Participants | — | 7 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Parents/LARs Not Hispanic or Latino | — | 25 Participants | — | 12 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Parents/LARs Unknown or Not Reported | — | 1 Participants | — | 0 Participants | 1 Participants |
| Race (NIH/OMB) DIVI Team American Indian or Alaska Native | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team Asian | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team Black or African American | 1 Participants | 1 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team More than one race | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) DIVI Team White | 8 Participants | 8 Participants | — | — | — |
| Race (NIH/OMB) Neonates American Indian or Alaska Native | — | 5 Participants | — | 1 Participants | 4 Participants |
| Race (NIH/OMB) Neonates Asian | — | 7 Participants | — | 0 Participants | 7 Participants |
| Race (NIH/OMB) Neonates Black or African American | — | 18 Participants | — | 6 Participants | 12 Participants |
| Race (NIH/OMB) Neonates More than one race | — | 2 Participants | — | 1 Participants | 1 Participants |
| Race (NIH/OMB) Neonates Native Hawaiian or Other Pacific Islander | — | 1 Participants | — | 1 Participants | 0 Participants |
| Race (NIH/OMB) Neonates Unknown or Not Reported | — | 12 Participants | — | 0 Participants | 12 Participants |
| Race (NIH/OMB) Neonates White | — | 44 Participants | — | 24 Participants | 20 Participants |
| Race (NIH/OMB) Parents/LARs American Indian or Alaska Native | — | 1 Participants | — | 0 Participants | 1 Participants |
| Race (NIH/OMB) Parents/LARs Asian | — | 1 Participants | — | 0 Participants | 1 Participants |
| Race (NIH/OMB) Parents/LARs Black or African American | — | 3 Participants | — | 1 Participants | 2 Participants |
| Race (NIH/OMB) Parents/LARs More than one race | — | 2 Participants | — | 1 Participants | 1 Participants |
| Race (NIH/OMB) Parents/LARs Native Hawaiian or Other Pacific Islander | — | 1 Participants | — | 1 Participants | 0 Participants |
| Race (NIH/OMB) Parents/LARs Unknown or Not Reported | — | 5 Participants | — | 0 Participants | 5 Participants |
| Race (NIH/OMB) Parents/LARs White | — | 27 Participants | — | 16 Participants | 11 Participants |
| Sex/Gender, Customized DIVI Team Female | 5 Participants | 5 Participants | — | — | — |
| Sex/Gender, Customized DIVI Team Male | 3 Participants | 3 Participants | — | — | — |
| Sex/Gender, Customized DIVI Team Unknown | 1 Participants | 1 Participants | — | — | — |
| Sex/Gender, Customized Neonates Female | — | 34 Participants | — | 15 Participants | 19 Participants |
| Sex/Gender, Customized Neonates Male | — | 49 Participants | — | 18 Participants | 31 Participants |
| Sex/Gender, Customized Neonates Unknown | — | 6 Participants | — | 0 Participants | 6 Participants |
| Sex/Gender, Customized Parents/LARs Female | — | 26 Participants | — | 11 Participants | 15 Participants |
| Sex/Gender, Customized Parents/LARs Male | — | 13 Participants | — | 8 Participants | 5 Participants |
| Sex/Gender, Customized Parents/LARs Unknown | — | 1 Participants | — | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 30 |
| other Total, other adverse events | 0 / 28 | 0 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | Change in Patient Experiences of Respect During Research Recruitment | 4.36 score on a scale |
| BRIEF Arm | Change in Patient Experiences of Respect During Research Recruitment | 4.76 score on a scale |
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Patient Trust in Research | 78 score on a scale | Standard Deviation 18 |
| BRIEF Arm | Patient Trust in Research | 77 score on a scale | Standard Deviation 11 |
Primary
Study Enrollment Rates
The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.
Time frame: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Study Enrollment Rates | Enrolled in DIVI | 13 Participants |
| Control Arm | Study Enrollment Rates | Not Enrolled in DIVI | 20 Participants |
| BRIEF Arm | Study Enrollment Rates | Enrolled in DIVI | 24 Participants |
| BRIEF Arm | Study Enrollment Rates | Not Enrolled in DIVI | 32 Participants |