Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04601246 |
Other study ID # |
3R01HD098178-02S1 |
Secondary ID |
3R01HD098178-02S |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2020 |
Est. completion date |
December 30, 2021 |
Study information
Verified date |
January 2022 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study will evaluate women's experiences with pain management and perceived attitudes
regarding opioid use for postpartum pain management and examine differences by race/
ethnicity. Women will participate in in-depth qualitative interviews regarding their
postpartum pain experience after a cesarean delivery. In this cohort, the investigators will
evaluate how experiences of postpartum pain management and perceptions of provider attitudes
vary across self-identified race/ethnicity. When applicable, mixed methods integration of
patient-reported and clinical data from NNM2 will also allow exploration of patient factors
contributing to such variation.
Description:
Opioid misuse has been declared a national emergency in the United States. Although the
opioid epidemic has touched all communities, there is a differential impact based on race and
ethnicity. In particular, data has shown that individuals of minority race/ ethnicity are
less likely to receive an opioid for pain management than non- Hispanic white individuals. As
birth is the most common reason for hospitalization, women of reproductive age are
particularly vulnerable to opioid exposure and to experiencing disparities in pain
management. Indeed, our data have demonstrated the high frequency of inpatient and outpatient
opioid use and wide variation in management of postpartum pain. Notably, data has shown that,
despite reporting higher levels of pain postpartum, minority race/ ethnicity women receive
less opioid treatment as inpatients and are less frequently prescribed an opioid upon
hospital discharge. Despite this plethora of quantitative data, few reports have explored
women's perspectives on the postpartum pain experience and disparities therein.
The investigators propose a qualitative study of women's experience with pain management in
the postpartum period. This proposal aims to fill an unmet need for a systematic, in-depth,
and unbiased evaluation of women's postpartum pain experiences, with a focus on racial/
ethnic disparities. The investigators will conduct in-depth interviews on the postpartum pain
experience among low-income women who have undergone cesarean delivery.
The first interview will be approximately 60 minutes long and will take place during the
postpartum hospitalization during days 1 through 4. All efforts will be made to interview the
participant at a time when she is comfortable, free of distraction, and not experiencing any
medical complications. Interviews will be conducted privately in the participant's hospital
room. All guests will be asked to leave the room for the interview and clinical interruptions
will be minimized. Interviewers will be trained in the confidential and sensitive conduct of
interviews about these topics. Interviews will be conducted by experienced research personnel
trained to perform in-depth, unbiased, professional interviews and who are fluent in English
and Spanish. The second interview will be by phone for 2 to 4 weeks after hospital discharge
that will last approximately 45 minutes.
Interview topics will address identify themes related to autonomy, respect, cultural views on
pain management, feeling heard/valued, communication with care team, understanding pain
management options, medication administration timing, and perceptions of provider judgment
related to opioids. This interview will also ask participants to self-identify their race and
ethnicity. Interviews will be audio-recorded. After completion of the interviews, the digital
audio files will be professionally transcribed prior to analysis.
This project takes an innovative approach in targeting health disparities in racial/ ethnic
minorities, who are disproportionately affected by maternal mortality and severe maternal
morbidity. Optimizing postpartum health, reducing opioid overuse, and reducing disparities in
care and outcomes are critical goals of major professional societies and the NICHD 2020
strategic plan. Understand the postpartum pain experience will inform future implementation
studies by providing an essential missing piece: women's voices and perspectives.
Furthermore, this work aims to identify root causes of racial/ ethnic disparities in
postpartum opioid use and pain management and allow a foundation from which to enact systems
and policies which guard against such disparities.