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NCT Number: NCT07166913

Enhancing Engagement of Partners in Research

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

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:

  • 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:

  • A lot of experience with stakeholder engagement (based on screener survey question)

Treatment and study plan

Toolkit

Behavioral

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 outcomes

  1. 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

  1. Patient Engagement in Research Scale (PEIRS) stakeholder engagement score

    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.

  2. Reading grade level of written materials

    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.

  3. Patient Education Materials Assessment Tool (PEMAT) score

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

H. Shonna Yin, MD, MS

CONTACT

[email protected]

646-501-4284

Jessica Velazquez-Perez

CONTACT

[email protected]

646-501-4288

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Enhancing Stakeholder Engagement in Pediatric Research

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Jul 31, 2026

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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