Enhancing Engagement of Partners in Research

NCT07166913 | Recruiting

• 2 other identifiers: 24-01851SOE-2022C2-28894
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Stakeholder Engagement

Outcome Measures

Primary Outcomes (1)

• Research Engagement Survey Tool (REST) stakeholder engagement score

  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.

  Month 6

Secondary Outcomes (3)

• 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

Study Arms (2)

Enhanced Strategies

EXPERIMENTAL

Subjects assigned to the Enhanced Strategies arm will receive a toolkit of enhanced stakeholder engagement strategies.

Behavioral: Toolkit

Standard Practice

NO INTERVENTION

No Intervention. Participants will continue to implement standard practices used by investigator

Interventions

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.

Enhanced Strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• H. Shonna Yin, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H. Shonna Yin, MD, MS

CONTACT

646-501-4284; Hsiang.Yin@nyulangone.org

Jessica Velazquez-Perez

CONTACT

646-501-4288; Jessica.velazquez@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 11, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Hsiang.Yin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)