Despite availability of cancer pain guidelines, unrelieved cancer pain remains a major public health problem. Barriers include: physician's lack of adequate opioid administration skills and inability to respond to pain control problems in a timely manner. One potential solution is the use of a protocol with a standardized order sheet. Our pilot trial indicates that an opioid titration order schema is both safe and effective in controlling cancer pain. The goal of this study is to compare the efficacy of a standardized order sheet versus usual care. Primary pain outcomes include intensity, duration (hours/day in pain), and distress. Quality of life is the secondary outcome measured in this study. This study is a multi-institutional trial conducted through the Vanderbilt Ingram Cancer Comprehensive Center Affiliate Network. Institutions will be randomly assigned to usual care (Arm A) or the opioid titration order sheet (Arm B). The experimental design uses nested components (patient/primary caregiver within physician practice within institution) with repeated measures. Baseline data collection includes pain intensity, duration, and distress (primarily outcomes), as well as quality of life (QOL), which includes a cancer-specific QOL measure, and measures of general function and mood disturbance (secondary outcomes). Confounding variables, which include provider compliance with the opioid titration order sheet, patient adherence to treatment recommendations, and active therapies that may reduce pain, will be collected. Primary outcomes will be measured with a daily pain dairy collected during a weekly telephone interview. Secondary outcomes will be measures at 2, 4, and 8 weeks. Telephone interviews will be used for all data collection points except baseline.
| Wells, Nancy; McDowell, M Rachel; Hendricks, Patty et al. (2011) Cancer pain management in ambulatory care: can we link assessment and action to outcomes? Support Care Cancer 19:1865-71 |
