Evaluation of the Communication Plan Early through End-of-Life (COMPLETE) Intervention

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The majority of children with cancer (>60%) experience pain and emotional suffering at end of life (EOL) and their parents experience distress. These children are not enrolled in hospice and have high rates of futile, high- intensity medical interventions (e.g., ICU admission) at EOL. In contrast, most parents would prefer a home death for their child. There is strong evidence in adults with cancer that hospice enrollment results in less pain and emotional suffering, fewer high-intensity medical interventions, and reduced caregiver distress. In adults, early EOL discussions facilitate longer hospice enrollment which is associated with better ratings of EOL care and is congruent with patient preferences. Early EOL discussions with parents of children with cancer fosters hope and emotional support and reduces uncertainty. However, no evidence-based interventions exist that foster early hospice enrollment or reduce the pain and emotional suffering in children with terminal cancer. The long-term goal is to identify effective interventions to improve child QOL at EOL and lessen parents’ distress. The overall objective of this application is to evaluate the efficacy of COMPLETE (Communication Plan: Early through End of Life), a series of tailored discussions delivered by the child’s primary MD/RN dyad, that begin at diagnosis, and integrates visual aids, to empathically facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that COMPLETE will foster alignment of goals of care between providers and parents when cure is unrealistic, leading to earlier hospice enrollment, reduced use of high-intensity medical interventions, and less pain and emotional suffering in children at EOL and less distress in parents. The hypotheses are based on the applicants’ pilot studies (NIHR21; NR011071-02): COMPLETE resulted in increased hospice enrollment (83% enrolled > 30 days vs 40% nationally), and lower use of high-intensity medical interventions (17% vs 60% nationally). Compared to baseline, children had significantly less pain and emotional suffering, and parents had significantly lower distress and uncertainty and more hope. The project rationale is that, if COMPLETE is efficacious, it can be rapidly translated into clinical practice to support earlier hospice enrollment and improve outcomes of children with cancer and their parents at EOL. In this multisite cluster-randomized controlled trial of children with cancer prognosis of < 25% survival and their parents, we aim to determine the efficacy of COMPLETE vs. Attention control to: 1. Foster earlier hospice enrollment (Primary Aim); 2. Decrease high- intensity medical interventions, decrease pain and emotional suffering in children at EOL; and, 3. Reduce parental distress and uncertainty and improve hope. The study innovations include using the oncology MD/RN team to engage parents from diagnosis and ongoing conversations using visual aids to help establish realistic goals of care that promote earlier hospice enrollment at EOL. The study significance is that it is expected to yield the evidence MD/RN teams need to promote better outcomes for children and parents at EOL.