Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
Condition: Opioid Misuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Background: Cesarean delivery is one of the most common obstetric procedures experienced
      among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of
      peripartum opioid prescriptions and persistent opioid use compared to those with vaginal
      deliveries.2 Since 2002, prescription opioid use and misuse has significantly increased among
      women, including those who are pregnant, showing over 31% increase in past-month heroin use
      among women of childbearing age.3 This indicates the importance of focusing on maternal
      population for prescribed opioid medication management during the immediate postpartum period
      to prevent long-term persistent opioid misuse. Few evidence-based approaches are available to
      remotely manage prescription opioid use post-discharge.4 Recent advances in mobile technology
      have made it possible to monitor behavior and maintain communication in near real-time, long
      after patients are discharged from their surgical procedures.5-7 Using a virtual platform via
      use of mobile technology offers potential for sustainable implementation of a behavioral
      intervention and patient-provider communication even during the COVID-19 pandemic.8
      Continuous Precision Medicine (CPM™; Research Triangle Park, NC) has developed a mobile app
      to overcome these barriers for tracking pain and pain medication use among post-surgery
      patients and tested the logistical and technological feasibility in postpartum patients at
      Temple OB/GYN. Collectively, our team brings expertise and collaborations between Temple
      University Hospital, RTI International, and CPM for the following Specific Aims:

      Aim 1: To examine the preliminary impact of the CPM mobile app to reduce the use of opioids
      among women post-Cesarean surgery Hypothesis 1: Patients using the CPM application will use
      fewer Morphine Milligram Equivalents (MME) compared to the blister package group.

      Aim 2: To establish correlates of pain medication use among women post-Cesarean surgery to
      estimate the appropriate recommendable dosages per model. Hypothesis 2: Structural and
      intermediary social determinants such as younger age, lower socioeconomic status, violence
      and trauma exposure, substance use disorder, and mental and physical health issues will be
      associated with more opioid medication use.
    

Detailed description: 
      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.
    

Intervention name(s): CPMRx
Intervention type(s): Behavioral
Intervention description(s): Patients use a mobile application to track pain medication usage and pain scores.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: opioid misuse; mobile application; cesarean section