Enhancing Engagement of Partners in Research

NYU Langone Health

Status: Enrolling

Conditions: Stakeholder Engagement

Treatments: Behavioral: Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT07166913

24-01851

SOE-2022C2-28894 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

Enhanced Strategies

Experimental group

Description:

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

Treatment:

Behavioral: Toolkit

Standard Practice

No Intervention group

Description:

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