Enhancing Engagement of Partners in Research

Not Applicable

Not yet recruiting

• Conditions: Stakeholder Engagement

• Registration Number: NCT07166913
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria:

1. 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.
2. 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).
3. Target n>50 participants in study.
4. 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:

1. >=12 years old;
2. Ability to speak either English, Spanish, or Chinese, and;
3. 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:

1. Not able to complete 6 month follow-up assessment
2. Children who are wards/foster children
3. Not able or willing to provide consent.
4. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Research Engagement Survey Tool (REST) stakeholder engagement score	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 Outcome Measures

Name	Time	Method
Patient Engagement in Research Scale (PEIRS) stakeholder engagement score	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.
Reading grade level of written materials	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.
Patient Education Materials Assessment Tool (PEMAT) score	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States