• Diana J Wilkie, Yingwei Yao, Miriam O Ezenwa, Marie L Suarez, Brenda W Dyal, Anayza Gill, Theresa Hipp, Robert Shea, Jacob Miller, Karen Frank, Nargis Nardi, Michael Murray, Julie Glendenning, Jessica Perez, Jesus D Carrasco, David Shuey, Veronica Angulo, Timothy McCurry, Joanna Martin, Adrienne Butler, Zaijie Jim Wang, and Robert E Molokie.
• Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA; University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA. Electronic address: diwilkie@ufl.edu.
• J Pain Symptom Manage. 2020 Mar 1; 59 (3): 626-636.

ContextUnrelieved cancer pain at the end of life interferes with achieving patient-centered goals.ObjectiveTo compare effects of usual hospice care and PAINRelieveIt® on pain outcomes in patients and their lay caregivers.MethodsIn a five-step, stepped-wedge randomized, controlled study, 234 patients (49% male, 18% Hispanic, 51% racial minorities) and 231 lay caregivers (26% male, 20% Hispanic, 54% racial minorities) completed pre-pain/post-pain measures. They received usual hospice care with intervention components that included a summary of the patient's pain data, decision support for hospice nurses, and multimedia education tailored to the patient's and lay caregiver's misconceptions about pain.ResultsThe intervention effect on analgesic adherence (primary outcome) was not significant. Post-test worst pain intensity was significantly higher for the experimental group, but the difference (0.70; CI = [0.12, 1.27]) was not clinically meaningful. There was nearly universal availability of prescriptions for strong opioids and adjuvant analgesics for neuropathic pain in both groups. Lay caregivers' pain misconceptions (0-5 scale) were significantly lower in the experimental group than the usual care group (mean difference controlling for baseline is 0.38; CI = [0.08, 0.67]; P = 0.01).ConclusionThis randomized controlled trial was a negative trial for the primary study outcomes but positive for a secondary outcome. The trial is important for clearly demonstrating the feasibility of implementing the innovative set of interventions.Copyright © 2019 American Academy of Hospice and Palliative Medicine. All rights reserved.

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