Postpartum PainNCT05202795
Postpartum Pain Experience and Attitudes About Opioid Prescribing
An observational study of Postpartum Pain and Pain Management, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpartum Pain, Pain Management, Opioid Prescribing
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Practicing health care providers in obstetrics/gynecology
Who may be able to join
- Practicing health care provider in obstetrics/gynecology at Northwestern Medicine
Who cannot join
- Below the age of 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Provider Perspectives on the Postpartum Pain Experience and Attitudes About Pain Management
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.
Read the 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.
- Conditions
- Postpartum Pain, Pain Management, Opioid Prescribing
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Badreldin, Northwestern University
- Investigators
- Nevert Badreldin, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202795
- Sponsor's protocol ID
- STU00215779
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Perspectives on the Postpartum Pain Experience and Attitudes About Pain Management
- ClinicalTrials.gov ID
- NCT05202795
- Acronym / sponsor ID
- STU00215779
- Conditions
- Postpartum Pain, Pain Management, Opioid Prescribing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Practicing health care providers in obstetrics/gynecology
Key inclusion criteria (1 listed)
- Practicing health care provider in obstetrics/gynecology at Northwestern Medicine
Key exclusion criteria (1 listed)
- Below the age of 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors which influence clinicians' management of postpartum pain
Time frame: 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.
1 secondary outcome
Clinicians' perspectives and preferences for interventions targeted at reducing postpartum opioid prescribing
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevert Badreldin, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Pain and Pain Management, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors which influence clinicians' management of postpartum pain (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.