A Stepped-Wedge Randomized Controlled Trial: Effects of eHealth Interventions for Pain Control among Adults with Cancer in Hospice.

Abstract

CONTEXT\nUnrelieved cancer pain at the end of life interferes with achieving patient-centered goals.\n\n\nOBJECTIVE\nTo compare effects of usual hospice care and PAINRelieveIt® on pain outcomes in patients and their lay caregivers.\n\n\nMETHODS\nIn a 5-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/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.\n\n\nRESULTS\nThe intervention effect on analgesic adherence (primary outcome) was not significant. Posttest 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 compared to the usual care group (mean difference controlling for baseline is 0.38; CI=[0.08, 0.67]; p=.01).\n\n\nCONCLUSION\nThis RCT 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.