Enhancing Stakeholder Engagement in Pediatric Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Research Engagement Survey Tool (REST) stakeholder engagement score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Standard Practice
No Intervention. Participants will continue to implement standard practices used by investigator
Enhanced Strategies
Subjects assigned to the Enhanced Strategies arm will receive a toolkit of enhanced stakeholder engagement strategies.
干预措施: Toolkit (Behavioral)
结局指标
主要结局
Research Engagement Survey Tool (REST) stakeholder engagement score
时间窗: 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.
次要结局
- Patient Engagement in Research Scale (PEIRS) stakeholder engagement score(Month 6)
- Reading grade level of written materials(Month 6)
- Patient Education Materials Assessment Tool (PEMAT) score(Month 6)