Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol.

INTRODUCTION: Despite increasing palliative care capabilities in the USA, utilisation rates remain low for patients with advanced cancer, particularly among African American patients. To address this gap, a theory-driven, stakeholder-informed community health worker (CHW) palliative care intervention for African American patients with advanced cancer and their informal caregivers is currently being assessed through a hybrid type 1 effectiveness-implementation trial at four cancer centres across the USA. To improve the quality and efficiency of palliative care delivery, inform resource allocation and guide broad-scale implementation, it is essential to generate evidence on the economic value of palliative care programmes. The objectives of this study are to evaluate the cost-effectiveness and estimate the social value of a CHW palliative care intervention for African American patients with advanced cancer and their caregivers. METHODS AND ANALYSIS: We will conduct cost-effectiveness analyses (CEAs) and a social return-on-investment (SROI) analysis to assess the value of the CHW palliative care intervention compared with enhanced standard of care. Standard, extended and distributional CEAs will be performed from the perspectives of an adopting organisation or payer (eg, Medicaid), the US healthcare sector and society. An SROI analysis will also be conducted to assess the social value of the intervention. These analyses will focus on estimating the costs, health and distributional impacts of the intervention. ETHICS AND DISSEMINATION: This study protocol was approved by the Johns Hopkins Medicine Institutional Review Board (IRB00372476). All methods will be carried out in accordance with relevant guidelines and regulations. Written informed consent will be obtained from all subjects prior to study participation. This manuscript does not contain participant-level data. The full protocol will be available from the corresponding author on reasonable request. The dissemination of findings from the clinical trial and accompanying economic evaluation outlined in this manuscript will be multifaceted to maximise reach and impact. Research findings will be presented at relevant scientific conferences, submitted for publication in peer-reviewed journals and shared with community stakeholders, including hospital leaders and administrators, providers, CHWs and patient advocacy groups. TRIAL REGISTRATION NUMBER: NCT05407844.