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

NCT05461196 | Completed

• 1 other identifier: 28226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Misuse

Keywords

opioid misuse; mobile application; cesarean section

Outcome Measures

Primary Outcomes (1)

• Morphine Milligram Equivalents (MME) Used

  Total number of Morphine Milligram Equivalents (MME) used during the postoperative period.

  First 7 days following discharge

Secondary Outcomes (1)

• Pain Scores

  Daily for 7 days following discharge

Study Arms (4)

Mobile App + BP

EXPERIMENTAL

Patients use a mobile application in addition to electronic monitoring blister packs for pain medications.

Behavioral: CPMRx

BP

NO INTERVENTION

Patients' pain medication is in electronic monitoring blister packs.

Mobile App Only

EXPERIMENTAL

Patients use a mobile application.

Behavioral: CPMRx

Control

NO INTERVENTION

Interventions

CPMRx BEHAVIORAL

Patients use a mobile application to track pain medication usage and pain scores.

Mobile App + BP; Mobile App Only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessica Morgan: lead
• Temple University: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

• Abdo A, O'Connor M, Morgan JK, Hart L, Leib A, Walther SK, Tang A, Herrine G. Evaluation of a mobile application to decrease opioid misuse in patients undergoing cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 5;24(1):812. doi: 10.1186/s12884-024-06953-7.

  PMID: 39639184 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gail Herrine, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Research

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: May 12, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)