Trial Outcomes & Findings for Discharge Opioid Education to Decrease Opioid Use After Cesarean (NCT NCT03678870)
NCT ID: NCT03678870
Last Updated: 2020-02-17
Results Overview
Median number of tablets of hydrocodone-acetaminophen used after hospital discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
196 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Education
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
99
|
|
Overall Study
COMPLETED
|
84
|
91
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
| Measure |
Education
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Overall Study
prescribed non- protocol medications
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Discharge Opioid Education to Decrease Opioid Use After Cesarean
Baseline characteristics by cohort
| Measure |
Education
n=84 Participants
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
n=91 Participants
Standard discharge instructions, which lists medications prescribed at discharge
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
30.5 years
STANDARD_DEVIATION 4.9 • n=107 Participants
|
30.2 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
52 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
91 participants
n=107 Participants
|
175 participants
n=206 Participants
|
|
High school education or less
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumMedian number of tablets of hydrocodone-acetaminophen used after hospital discharge
Outcome measures
| Measure |
Education
n=84 Participants
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
n=91 Participants
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Opioid Use
|
7.5 hydrocodone tablets
Interval 2.0 to 15.0
|
10 hydrocodone tablets
Interval 2.0 to 16.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Denominator includes only women who had leftover opioids
Frequency of women reporting that they either returned their unused opioids to a pharmacy or flushed them down the toilet
Outcome measures
| Measure |
Education
n=79 Participants
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
n=83 Participants
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Disposed of Opioids Correctly
|
30 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumMedian score on an assessment of characteristics of analgesics including side effects, risks, and benefits. Score 1-10 for each question. Higher score is better.
Outcome measures
| Measure |
Education
n=84 Participants
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
n=91 Participants
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Analgesic Quiz Score
|
10 score on a scale
Interval 9.0 to 10.0
|
8 score on a scale
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPercentage of patients obtaining additional prescriptions for pain
Outcome measures
| Measure |
Education
n=84 Participants
Opioid Education
Opioid Education Handout: a single page handout with information about how to use medications for pain after discharge.
|
Control
n=91 Participants
Standard discharge instructions, which lists medications prescribed at discharge
|
|---|---|---|
|
Additional Prescriptions
|
4 Participants
|
1 Participants
|
Adverse Events
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Osmundson, Assistant Professor of Obstetrics and Gynecology
Vanderbilt University Medical Center
Phone: (615) 343-7869
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place