NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT07166913
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria:
In order for study stakeholders to be eligible to participate in this study, an individual must meet all of the following criteria:
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:
In addition, PI's who meet the following criteria will be excluded from participation in this study:
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.
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.
Time frame: Month 6
The scale consists of 22 items and assesses engagement across seven domains, using a 5-point Likert scale for each item. The 7 domains include: 1) procedural requirements, 2) convenience, 3) contributions, 4) team environment and interaction, 5) support, 6) feel valued, and 7) benefits. The total score is calculated by summing the scores for each item and dividing by the maximum possible score. This result is then multiplied by 100 to get a score out of 100. Higher scores indicate a greater degree of meaningful patient engagement.
Time frame: Month 6
Mean of 5 readability formulas (Flesch Reading Ease, Flesch-Kincaid, Simple Measure of Gobbledygook (SMOG), Gunning Fog, Forcast). Lower score reflects lower reading grade level.
Time frame: Month 6
Consists of Understandability (19 items) and Actionability (7 items) subscales. Scoring is as follows: (Total points / possible points yields) x100 = Score %. Higher score reflects greater understandability / actionability.
Contact information is provided by the study sponsor or research team.
H. Shonna Yin, MD, MS
CONTACT
Jessica Velazquez-Perez
CONTACT
NYU Langone Health
Other
Enhancing Stakeholder Engagement in Pediatric Research
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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