Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT” (ASCENT) Clinical Trial

摘要

Abstract Cancer pain disparities are profound and uniquely harmful among Hispanic/Latinx and rural dwelling survivors as they undermine their already limited ability to access, tolerate, and/or receive treatment for their cancer. Disparities are tied to poor care, needlessly persistent and intense pain, as well as the over- and under-prescribing of opioids. Multi-modal pain care (MMPC), a robustly validated, safer, and more effective alternative to a solely medication-based approach has proven challenging to implement broadly, and virtually impossible in resource limited settings. The factors that impede delivery of MMPC; provider bias, patients’ reluctance to report pain, and lack of patient-centered MMPC options, also mediate disparities making them key targets for improvement. The Collaborative Care Model (CCM) provides a well-es- tablished and validated framework that can neutralize factors that perpetuate disparities, guide MMPC delivery, and im- prove pain detection and treatment. However, as currently configured the CCM’s single symptom emphasis needs to be modified to address the multi-level drivers of pain disparities. Our team has developed and tested CCM iterations that inte- grate elements of team-based care (TBC) to improve the CCM’s monitoring of sociocultural needs, as well as to accommo- date MMPC’s multi-disciplinary care requirements. In addition, we have leveraged electronic health records (EHRs) to en- able care teams to link symptomatic cancer patients with MMPC providers and resources. Our prior research deploying CCM-TBC hybrid interventions with patient-and-care team-centered EHR-reengineering has also significantly improved patient symptom reporting and deployment of MMPC. These efforts, while fruitful, have also shown us that a broader EHR retrofitting is required to address the breadth of patients’ needs and the requirements of real-world clinical work- flows. This experience suggests that a flexible, modular CCM-TBC hybrid system, supported by EHR enablement, can de- liver high fidelity MMPC in a manner that improves care and mitigates disparities at multiple levels among Hispanic and rural cancer survivors. We plan to evaluate the effectiveness of this approach in a clinical trial entitled “Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT (ASCENT ).” More specifically, we will part- ner with our community stakeholders during an initial, 1-year R61 development phase to refine a culturally informed version of our CCM-TBC hybrid that addresses Hispanic and rural survivors’ linguistic, social, and IT needs (Aim 1). After confirming the functionality of the intervention’s components, we plan to transition to a 4-year R33 execution phase with a 2-arm, parallel group randomized clinical trial. This trial (Aim 2) will be conducted in 4 semi-autonomous Health Care Sys- tems and is designed to assess whether our culturally informed CCM-TBC hybrid intervention improves pain outcomes rela- tive to usual care among 578 survivors, 60% rural and 60% Hispanic, assuming 30% overlap. Primary (pain) and secondary (mood, sleep, physical function, work status, and healthcare utilization) outcomes will be assessed at 0, 3, and 6 months. All data, excepting patient reported outcome measures, will be extracted from the EHR for main effects, as well as explora-tory mediator and machine learning analyses; the latter to identify characteristics associated with positive responses. Aim 3 will evaluate implementation strategies to support multistakeholder adoption and use of intervention components.