Enhancing Engagement of Partners in Research

Официальное название

Enhancing Stakeholder Engagement in Pediatric Research

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Patient Engagement in Research Scale (PEIRS) stakeholder engagement score [Срок оценки: Month 6]
• Reading grade level of written materials [Срок оценки: Month 6]
• Patient Education Materials Assessment Tool (PEMAT) score [Срок оценки: Month 6]

Критерии участия

Критерии включения

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.

Критерии исключения

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:

1\. A lot of experience with stakeholder engagement (based on screener survey question)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07166913 · 24-01851 · SOE-2022C2-28894

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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