Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section

Experimental Design: A randomized pilot trial will be conducted with 100 females at Temple University Hospital immediately post-Cesarean delivery. The women will be randomized (1:1) to either: using the CPM mobile app and electronic monitoring blister packs (experimental group) or to blister packs only (control group). The primary outcome is Morphine Milligram Equivalents (MME). Secondary outcomes will be delay to dosages and pain scores. We will examine whether a mobile application found feasible by post-surgery patients and healthcare professionals has a preliminary impact on opioid medication use among women who are immediately postpartum and had Cesarean surgery. The CPM application provides patients with a detailed prescription regimen, allows a patient to report dose-by-dose pain scores, and helps the patient consider whether a dose is needed via gamification, and creates usage traceability for clinicians to reduce over-prescription. Linear regression, including ANOVA and repeated mixed models will be used to compare groups on the primary continuous outcomes of daily MME during the 10-day period. The initial models will only include a term for study group. Variables that are statistically significant (<0.05) by univariate analyses, as well as theoretically important covariates will be considered for inclusion in adjusted analyses to improve their precision. Pain scores as a secondary continuous outcome will be evaluated using regression models for linear and non-linear mixed effect models. If no significant differences in these outcomes were detected, resampling Bootstrap method will be used to estimate effect sizes (i.e., Cohen's d) and its 95% confidence intervals, considering potential non-normal distribution of data. Further, we will utilize structural equation modeling (SEM) for its greater flexibility and capacity of handling the structural relationship between measured variables and latent constructs.

Inclusion criteria

• Patient is a female adult between the ages of 18-50 years
• Patient is undergoing cesarean section procedure at Temple University Hospital
• Patient is able and willing to provide informed consent
• Patient has insurance that will cover cost of prescription drugs or is able to pay out-of-pocket
• Patient has their own smart mobile phone (>80% of the target population owns a mobile phone)

Exclusion criteria

• Patient with contraindications to opioid medications, NSAIDs, or acetaminophen (including but not limited to allergy, intolerance, inability to swallow pills, etc.)
• Patient is unable to take tablets or tolerate oral intake
• Patient has a diagnosis of acute or chronic pain disorder
• Patient has used an opioid within the past 12 months
• Patient is non-English speaking
• Patient is unable to provide consent
• Patient is currently incarcerated