Enhancing Stakeholder Engagement in Pediatric Research
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 480
- Locations
- 2
- Primary Endpoint
- Research Engagement Survey Tool (REST) stakeholder engagement score
Study Overview
Brief Summary
The purpose of this study is to examine the implementation and effectiveness of a bundle of engagement strategies for pediatric patient centered outcomes research (PCOR) studies. The study aims to examine the effectiveness of a "bundle" of enhanced engagement strategies on improved stakeholder engagement and study protocol indicators (including improved language access, meeting recruitment/retention goals) compared to standard practice.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria:
- •Studies who either have not started enrollment or are within 1-3 months of the start of enrollment, and within the 25% ceiling for % recruitment target.
- •Studies that have started enrollment must be no further than 25% of projected enrollment timeline of the study (with at least 6 months remaining for enrollment).
- •Target n>50 participants in study.
- •At least 10 stakeholder partners part of study. The PI's must also be ≥18 years old;
- •In order for study stakeholders to be eligible to participate in this study, an individual must meet all of the following criteria:
- •>=12 years old;
- •Ability to speak either English, Spanish, or Chinese, and;
- •Part of the study team or serving in an advisory capacity to the study team
- •The same criteria as that used for stakeholder and PI eligibility applies to Key informant (KI) interviews.
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Not able to complete 6 month follow-up assessment
- •Children who are wards/foster children
- •Not able or willing to provide consent.
- •Concurrent enrollment in another study that is part of this research project.
- •In addition, PI's who meet the following criteria will be excluded from participation in this study:
- •1. A lot of experience with stakeholder engagement (based on screener survey question)
Arms & Interventions
Standard Practice
No Intervention. Participants will continue to implement standard practices used by investigator
Enhanced Strategies
Subjects assigned to the Enhanced Strategies arm will receive a toolkit of enhanced stakeholder engagement strategies.
Intervention: Toolkit (Behavioral)
Outcomes
Primary Outcomes
Research Engagement Survey Tool (REST) stakeholder engagement score
Time Frame: Month 6
This tool consists of 32 items and assesses engagement across 8 domains, using a 5-point Likert scale for each item. The 8 domains include: 1) focus on community perspectives and determinants of health, 2) partner input, 3) partnership sustainability, 4) fostering co-learning, capacity building and co-benefit, 5) building on strengths and resources, 6) facilitating collaborative, equitable partnerships, 7) involving partners in the dissemination process, and 8) building and maintaining trust. Engagement principle (EP) scores are calculated as an average of non-missing items. The 8 means are used to calculate the overall stakeholder engagement score. Higher scores indicate higher degree of stakeholder engagement.
Secondary Outcomes
- Patient Engagement in Research Scale (PEIRS) stakeholder engagement score(Month 6)
- Reading grade level of written materials(Month 6)
- Patient Education Materials Assessment Tool (PEMAT) score(Month 6)