Improving partner engagement in pediatric patient-centered outcomes

Enhancing Stakeholder Engagement in Pediatric Research

We will try a package of enhanced engagement strategies to see if they help stakeholder partners stay involved and improve recruitment, retention, and language access in pediatric patient-centered outcomes studies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07166913 on ClinicalTrials.gov

What this trial studies

PCOR study teams led by eligible principal investigators will implement a bundled toolkit of enhanced engagement strategies and compare outcomes to standard practice. Eligible study teams must be starting or early in enrollment, target at least 50 participants, and include at least 10 stakeholder partners; stakeholders must be ≥12 years old and speak English, Spanish, or Chinese. The implementation will track stakeholder engagement metrics, protocol indicators such as meeting recruitment and retention goals, and language access improvements, supplemented by key informant interviews. The intervention is coordinated by NYU Langone Health with support from the Patient-Centered Outcomes Research Institute and delivered to participating teams and their stakeholders.

Who should consider this trial

Good fit: Ideal participants are PIs overseeing qualifying pediatric patient-centered outcomes studies and their stakeholder partners aged 12 or older who speak English, Spanish, or Chinese.

Not a fit: People who are not part of qualifying study teams, studies with small targets (<50) or well past early enrollment milestones, stakeholders under 12, or those who do not speak English, Spanish, or Chinese are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could make pediatric PCOR studies more inclusive and effective by increasing stakeholder involvement, improving recruitment and retention, and expanding language access.

How similar studies have performed: Prior work shows that stakeholder engagement can improve study relevance and recruitment, but using a standardized bundled toolkit across multiple pediatric PCOR studies is relatively novel and not widely tested.

Eligibility criteria

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)

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: H. Shonna Yin, MD, MS — NYU Langone Health
• Study coordinator: H. Shonna Yin, MD, MS

Conditions Stakeholder Engagement