RÉSUMÉ
BACKGROUND: Despite strong and growing interest in ending the ongoing opioid health crisis, there has been limited success in reducing the prevalence of opioid addiction and the number of deaths associated with opioid overdoses. Further, 1 explanation for this is that existing interventions target those who are opiate-dependent but do not prevent opioid-naïve patients from becoming addicted. OBJECTIVE: Leveraging behavioral economics at the patient level could help patients successfully use, discontinue, and dispose of their opioid medications in an acute pain setting. The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to the standard of care by leveraging a pragmatic randomized controlled trial (RCT). METHODS: A team of researchers from the Center for Learning Health System Sciences (CLHSS) at the University of Minnesota partnered with M Health Fairview to design, build, and test the 3 versions of the OPY tool: social influence, precommitment, and testimonial version. The tool is being built using the Epic Care Companion (Epic Inc) platform and interacts with the patient through their existing MyChart (Epic Systems Corporation) personal health record account, and Epic patient portal, accessed through a phone app or the MyChart website. We have demonstrated feasibility with pilot data of the social influence version of the OPY app by targeting our pilot to a specific cohort of patients undergoing upper-extremity procedures. This study will use a group sequential RCT design to test the impact of this important health system initiative. Patients who meet OPY inclusion criteria will be stratified into low, intermediate, and high risk of opiate use based on their type of surgery. RESULTS: This study is being funded and supported by the CLHSS Rapid Prospective Evaluation and Digital Technology Innovation Programs, and M Health Fairview. Support and coordination provided by CLHSS include the structure of engagement, survey development, data collection, statistical analysis, and dissemination. The project was initially started in August 2022. The pilot was launched in February 2023 and is still running, with the data last counted in August 2023. The actual RCT is planned to start by early 2024. CONCLUSIONS: Through this RCT, we will test our hypothesis that patient opioid use and diverted prescription opioid availability can both be improved by information delivery applied through a behavioral economics lens via sending nudges directly to the opioid users through their personal health record. TRIAL REGISTRATION: ClinicalTrials.gov NCT06124079; https://clinicaltrials.gov/study/NCT06124079. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52882.
RÉSUMÉ
Objective:To evaluate the safety and efficacy of dosing transdermal fentanyl patch by patient-controlled intravenous anal-gesia (PCIA) with fentanyl to treat opioid-naive patients suffering from cancer-related pain. Methods:In this open non-controlled trial, 30 patients with moderate to severe cancer pain were enrolled in the study. Titration conditions, pain score (NRS), and pain of life im-pact scores were assessed and recorded during four periods of treatment, as follows:before fentanyl-PCIA;during fentanyl-PCIA treat-ment;during Duragesic with fentanyl-PCIA treatment;and during Duragesic treatment. Adverse reactions were assessed and recorded during the two periods of treatment (the period before fentanyl-PCIA and the period after fentanyl-PCIA). Results:A total of 20 cases of titration were a success, whereas 10 cases failed. The general pain score, the most serious pain score, activity pain score, resting pain score, and the pain of life impact scores were all significantly reduced during fentanyl-PCIA treatment, during Duragesic with fen-tanyl-PCIA treatment, and during Duragesic treatment compared with the period before fentanyl-PCIA treatment (P<0.05). Nausea was the only adverse reaction that occurred during treatment. Obvious muscle rigidity, loss of consciousness, cough, respiratory depres-sion, and bradycardia were not observed. Conclusion:Dose titration of transdermal fentanyl patch with fentanyl administrated by PCIA for opioid-naive patients provides an effective and convenient method for pain relief treatment.