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The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion. Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (~25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored | Experimental | Participants will be prescribed an opioid based on a formula derived from inpatient opioid use |
|
| Control | Other | Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored prescription | Other | Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unused Opioids | oxycodone 5mg tablet leftover from prescription at discharge | 4 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Pain: Frequency That Participants Reported Uncontrolled Pain | Frequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0) |
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Inclusion Criteria:
Exclusion Criteria:
Postpartum women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Osmundson | Nashville | Tennessee | 37215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30095773 | Derived | Osmundson SS, Raymond BL, Kook BT, Lam L, Thompson EB, Schornack LA, Voorhees CE, Richardson MG. Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):624-630. doi: 10.1097/AOG.0000000000002782. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored | Participants will be prescribed an opioid based on a formula derived from inpatient opioid use Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use |
| FG001 | Control | Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. Control: Participants will be prescribed 30 tablets of oxycodone 5mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored | Participants will be prescribed an opioid based on a formula derived from inpatient opioid use Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 7 tailored/ 11 control subjects lost to follow-up |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unused Opioids | oxycodone 5mg tablet leftover from prescription at discharge | Posted | Median | Inter-Quartile Range | oxycodone 5mg tablets | 4 weeks postpartum |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored | Participants will be prescribed an opioid based on a formula derived from inpatient opioid use Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Osmundson, MD | Vanderbilt University Medical Center | +1 (615) 343-5700 | sarah.osmundson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2018 | Feb 22, 2019 | Prot_SAP_000.pdf |
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Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
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| Control | Other | Participants will be prescribed 30 tablets of oxycodone 5mg |
|
| 4 weeks postpartum |
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. Control: Participants will be prescribed 30 tablets of oxycodone 5mg |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 7 Tailored/ 11 control subjects lost to follow-up | Count of Participants | Participants |
|
| Race (NIH/OMB) | 11 Tailored/ 7 control subjects were lost to follow-up | Count of Participants | Participants |
|
| Region of Enrollment | 7 Tailored/ 11 Control subjects lost to follow-up | Number | participants |
|
|
|
| Secondary | Pain: Frequency That Participants Reported Uncontrolled Pain | Frequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0) | Posted | Median | Inter-Quartile Range | score on a scale | 4 weeks postpartum |
|
|
|
| 0 |
| 94 |
| 1 |
| 94 |
| 0 |
| 94 |
| EG001 | Control | Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. Control: Participants will be prescribed 30 tablets of oxycodone 5mg | 0 | 96 | 0 | 96 | 0 | 96 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|