Enhancing Engagement of Partners in Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toolkit.
- Who it may be relevant to
- Registry conditions: Stakeholder Engagement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancing Stakeholder Engagement in Pediatric Research
Overview
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.
Interventions
- Behavioral Toolkit
The toolkit contains information regarding enhanced stakeholder engagement strategies. The toolkit includes guidance materials, checklists, and templates/ sample materials, to increase stakeholder engagement in the research. This includes guidance on setting up a stakeholder advisory board (SAB) and ensuring literacy- and language- sensitivity of participant-/stakeholder-facing materials.
Primary outcome measures
- Research Engagement Survey Tool (REST) stakeholder engagement score [Time frame: Month 6]
Secondary outcome measures (3)
- Patient Engagement in Research Scale (PEIRS) stakeholder engagement score [Time frame: Month 6]
- Reading grade level of written materials [Time frame: Month 6]
- Patient Education Materials Assessment Tool (PEMAT) score [Time frame: Month 6]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07166913 · 24-01851 · SOE-2022C2-28894