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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05202795
Other study ID # STU00215779
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date July 1, 2022

Study information

Verified date February 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Practicing health care provider in obstetrics/gynecology at Northwestern Medicine Exclusion Criteria: - Below the age of 18 years old

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Factors which influence clinicians' management of postpartum pain 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. through study completion, an average of 1 year
Secondary Clinicians' perspectives and preferences for interventions targeted at reducing postpartum opioid prescribing 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. through study completion, an average of 1 year
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