Postpartum Pain Experience and Attitudes About Opioid Prescribing

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05202795
Collaborator
(none)
50
1
23
2.2

Study Details

Study Description

Brief Summary

This is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Opioid misuse has been declared a national emergency in the United States. More than half of hospitalized patients receive an opioid during their hospitalization. As birth is the most common reason for hospitalization, reproductive-aged individuals are particularly vulnerable to opioid exposure and are an important population for addressing the opioid epidemic. Indeed, data have demonstrated the high frequency of postpartum inpatient and outpatient opioid use, the wide variation in postpartum pain management, the lack of alignment of opioid prescribing with patient reports of pain, and the contributions of obstetric clinicians to opioid prescribing.

    The opioid epidemic has a differential impact by race/ethnicity; individuals of minority race/ethnicity are less likely to receive an opioid for pain management than non-Hispanic White individuals. Notably, data show that, despite reporting higher levels of pain postpartum, minority race/ethnicity birthing individuals receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. A complete understanding and, ultimately improvement, of these experiences and reduction in disparities requires a deeper delve into influences which guide clinicians in their management of postpartum pain.

    This investigation aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of obstetric clinicians' experience of postpartum pain management. This is a prospective qualitative study of obstetric clinicians, examining factors which influence their approach to postpartum pain management, biases which may contribute to disparities, and their perspectives and preferences of interventions to reduce opioids and improve pain control. Investigators will conduct in-depth semi-structured interviews with up to 50 obstetric clinicians, including physicians, advanced practitioners, and nurses. Aim 1 will evaluate beliefs and factors which influence clinicians' management of postpartum pain, including potential clinician-level biases which may contribute to disparities. Using the Consolidated Framework for Implementation Science, Aim 2 will evaluate clinicians' perspectives and preferences of interventions to reducing postpartum opioid prescribing and improving pain control, in order to optimize the implementation of future interventions.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Provider Perspectives on the Postpartum Pain Experience and Attitudes About Pain Management
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Factors which influence clinicians' management of postpartum pain [through study completion, an average of 1 year]

      Through analysis of qualitative interviews, themes such as approaches to pain management, awareness of disparities in pain management, and beliefs about cultural and social influences of pain will be reviewed. The constant comparative method will be applied.

    Secondary Outcome Measures

    1. Clinicians' perspectives and preferences for interventions targeted at reducing postpartum opioid prescribing [through study completion, an average of 1 year]

      Through analysis of qualitative interviews, themes such as knowledge, acceptability, barriers, feasibility, health impact, and perceived need will be reviewed for different types of interventions to reduce opioid prescribing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Practicing health care provider in obstetrics/gynecology at Northwestern Medicine
    Exclusion Criteria:
    • Below the age of 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Memorial Hospital Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Nevert Badreldin, MD, MS, Northwestern University Feinberg School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nevert Badreldin, Assistant Professor of Obstetrics and Gynecology (Maternal Fetal Medicine), Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05202795
    Other Study ID Numbers:
    • STU00215779
    First Posted:
    Jan 24, 2022
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 24, 2022