N/A
N=56
24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery
Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04043143 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Prescribed Post-discharge Opioids — 55.3; 62.8 Oral Morphine Equivalent units (OME)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arm 1 Prescription As Usual (Other); Arm 2 Prescription Tool Intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prescribed Post-discharge Opioids |
55.3; 62.8 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1 |
62.0; 58.0 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2 |
55.2; 51.9 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3 |
50.1; 48.6 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4 |
47.4; 46.3 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1 |
58.3; 55.6 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2 |
53.3; 49.9 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3 |
48.6; 45.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4 |
45.2; 43.6 | — |
Summary
The investigators will utilize the electronic health record to individualize pain therapy in surgical patients after hospital discharge using last 24-hour opioid intake as the decision variable for the amount of opioid pain pills prescribed. The preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use 24 hours prior to discharge serves as a strong indicator to correctly estimate needs for analgesic medications at home. The investigators will test the hypothesis that this prescription estimation tool will enable providers to write need-based prescriptions based on each patient's' 24-hour prior-to-discharge opioid use. The investigators will test this tool prospectively for patients after Cesarean section who are anticipated to use about half or less of the usually prescribed amount of opioid pain pills after discharge randomized equally to prescription tool intervention or no intervention (prescription as usual).
Eligibility Criteria
Inclusion Criteria
- Women ages at least 18 years of age having undergone Cesarean section surgery at the University of Colorado Hospital are eligible.
- Willingness to complete weekly surveys for 4 weeks after discharge.
- Anticipated to need half or less of the usually prescribed amount of opioids based on the amount of opioids taken in the last 24 hours prior to the opioid medication being written for discharge (only patients who took 22.5 MME or less opioids in the last 24 hours prior to the day of discharge will be eligible for this study).
Exclusion Criteria
- Patients under the age of 18 years.
- Patients returning to institutional settings (e.g. prison, jail, mental health facility).
- Pregnant women (patients will be approached after their C-section).
- Decisionally challenged patients.
- Blind or illiterate patients.
Based on prior research factors such as emergency status, prior opioid use, repeat vs primary C-section, and associated procedures were not associated with post-discharge opioid use once the investigators adjusted for last-24 hour inpatient opioid use. Hence, these patients will not be excluded.
Inclusion and exclusion criteria (including the amount of opioids taken in the last 24 hours prior to discharge) will be evaluated in the morning in patients scheduled to be discharged later that day.
Data sourced from ClinicalTrials.gov (NCT04043143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.