Recruiting

Engagement Strategies

Sponsor:

NYU Langone Health

Code:

NCT07166913

Conditions

Stakeholder Engagement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Toolkit

Study Details

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

Study ID

NCT07166913

Start date

Sep 8, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Enhanced Strategies

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

no intervention: Standard Practice

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

Interventions

Toolkit

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 outcome measure

  • Research Engagement Survey Tool (REST) stakeholder engagement score [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-31.