P3.E097: Study Protocol for the Missing Pieces Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

Background:

Background: In the US ~60,000 people under 25 die annually, 45% resulting from traumatic events. Bereaved families, including siblings, experience disruptions in daily life, mental and physical health. Parents’ or caregivers’ (hereafter “parents”) sole contact with the healthcare system is often the medical examiner (ME) or coroner’s office. Yet, ME/coroners have little guidance to support grieving families. Experts note that bereavement support should be a public health issue. Thus scalable, systems-level interventions are needed. We designed a trial built upon (1) CommunityRx, an evidence-based social care intervention, (2) years of community engagement with collaborators, and (3) the experience of Missing Pieces, a community organization that supports people after pediatric death. Our aim was to compare the effectiveness of two interventions provided by Missing Pieces: (1) CommunityRx-Bereavement (CRx-B), a longitudinal Grief Navigator-based intervention including sharing personalized resource information, and (2) general bereavement support information (GBSI), a unidirectional text message sharing of a list of community resources.
Objective & Research Questions: The objective of this presentation is to describe the development and design of the study protocol, which examines three questions: 1) What is the impact of CRx-B vs. GBSI on parent-centered outcomes (PCOs)? 2) What are the mechanisms of impact on these PCOs, and what factors result in heterogeneity of these effects among parents? and 3) What are common barriers to and facilitators of intervention implementation in the real world?

Methods:

Methods: Community collaborators, including bereaved parents, community-based organizations, ME/coroners, and professional advocacy organizations, convened multiple times. Together, the study team and collaborators adapted an existing conceptual framework for the CommunityRx intervention aligning salience to the study population (Figure 1). Based on the adapted framework, collaborators designed the study and research materials, enrollment protocols, and study instruments.

Results:

Results: The hybrid type 1 implementation effectiveness study (Figure 2) launched in March 2024. Bereaved parents of deceased children ( < 25 years old) are referred by ME/Coroners to Missing Pieces, then randomized to CRx-B or GBSI. The co-primary outcomes include the effect of the interventions on complicated grief and self-efficacy for finding resources at 6.5 months, assessed by parent surveys. (Figure 1 summarizes primary and secondary outcomes.) To assess implementation outcomes, ME/coroner staff will complete surveys and interviews and data will be collected from Missing Pieces reports. The main quantitative analyses will follow the intent-to-treat principle, use generalized linear mixed-effects models. Qualitative data will be analyzed using a framework analysis including both inductive and deductive theme identification.

Conclusion:

Discussion: Evidence-based strategies are needed to support parents after the traumatic death of their child. This real-world trial will inform best practices for ME/coroners and grief support organizations. Collaborators and the study team will work together to interpret and disseminate study findings.