Clinical trial NCT04043143: 24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery
Official title: 24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: opioids
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-02
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will test this tool prospectively for Cesarean section patients anticipated to use about half or less of the usually prescribed amount of opioid pain pills randomized equally to prescription tool intervention or no intervention (prescription as usual).
Primary purpose: OTHER

Brief 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).

Detailed description: Prescription opioid overdose has emerged as a leading cause of death in the general population. Opioid-based therapy represents a corner-stone of post-operative pain management. With increasing emphasis on robust pain therapy, sales of opioid medications have increased four-fold in the last decade. Parallel to this rise, opioid-associated deaths have also quadrupled. The investigators have shown that long-term opioid use occurs in up to 22% of patients following surgery. Over-prescribed opioids after surgery can create a reservoir of opioids that become available for non-medical use. Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are lacking. Thus, there is an urgent need to individualize post-operative pain therapy and reduce reliance on opioids.

Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this study is to prescribe pain medications after surgery in a patient-centered fashion. The investigators will use the average amount of opioid medications (in oral morphine equivalents - OME) taken in the last 24 hours prior to discharge to inform and design a clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated "last 24 hour OME dose" will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be shared with the provider when the post-discharge pain medication is made, e.g. via displaying the last 24-hour opioid use in the electronic health record (EHR). The rationale is that testing of such a decision-making tool will lay the groundwork to translate the findings of this project into more secure and efficient opioid prescribing practices to a system-wide level. Upon completion, the investigators expect to have developed an effective decision-making tool to help providers estimate required pain medication following patient discharge.

The investigators will perform a randomized clinical trial (RCT) of an Electronic Health Record (EHR)-based recommendation to prescribe opioids at discharge according to the recorded last 24-hour inpatient use according to current recommendations and evaluate its effect on the amount of opioids prescribed as well as pain control after discharge.

Using the University of Colorado Hospital Epic/Clarity database, the investigators will continuously identify all patients who underwent Cesarean section surgery at University Hospital. Patients will be approached regarding interest in the study prior to hospital discharge.A trained Professional Research Assistant or other provider will explain the study and obtain informed consent from prospective participants. After consent, demographics and the best contact information will be collected from those enrolled patients who indicate they are interested in completing the surveys after their hospital discharge.

The investigators expect 44 patients to complete all four weekly surveys and define the intent-to-treat sample as patients who complete one or more surveys (providing at least one observation to be used in analyses). To conservatively allow for increased variability due to attrition, 54 patients will be randomized equally electronically to intervention (prescription tool) or no intervention (prescription as usual). The investigators will use an electronic randomization scheme created so that the principal investigator and statistician can remain blind to assignment.

In the intervention group (Arm 2), at the time of writing the prescription for a patient, the provider will be informed that a patient may be considered for a lower post-discharge opioid dose (No opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken equal or less than 22.5 MME (morphine milligram equivalent), e.g. 1-3 oxycodone 5mg tablets in the last 24 hours.) In the control group (Arm 1), providers will receive a message to consider prescribing the usual medications for pain management after discharge. Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. For this pilot study, the provider information (best practice alert - BPA) will be operationalized via a written recommendation on paper handed to the provider by study staff in a sealed envelope that the provider will be asked to open and read. Alternatively the BPA may be presented electronically using a screen. Providers will be asked to acknowledge that they read the BPA by closing the window or opening the envelope.

One week after hospital discharge interested patients will be contacted and asked to complete the first of four surveys. All communication will be available in English. Patients will be paid with a $10 gift card or money order equivalent to complete the study assessments using REDCap at each of the four weekly follow-up time points ($40 total). All enrolled patients will complete the weekly post-discharge surveys within REDCap or hard copy if they do not have internet access.

The study team will contact all subjects \~2 weeks after discharge to ask about pain management and monitor the need for secondary prescriptions from providers to ensure that no significant under-prescription of opioid medications after surgery occurs.

The investigators will seek follow-up with providers about the usefulness and acceptability of the EHR-based intervention. Providers will be surveyed with a REDCap survey using a modified version of the GUIDES checklist, which provides a tool to improve the successful use of guideline-based computerized clinical decision support.

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.

Primary outcomes:
measure: Prescribed Post-discharge Opioids
timeFrame: Date of admission to the hospital up to 60 days after the date of hospital discharge.
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1
timeFrame: One week after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2
timeFrame: Two weeks after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3
timeFrame: Three weeks after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4
timeFrame: Four weeks after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1
timeFrame: One week after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2
timeFrame: Two weeks after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3
timeFrame: Three weeks after hospital discharge date.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4
timeFrame: Four weeks after hospital discharge date.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References:
citation: Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
citation: Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
citation: Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
citation: Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
citation: Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
citation: Bartels K, Binswanger IA, Hopfer CJ. Sources of Prescription Opioids for Nonmedical Use. J Addict Med. 2016 Mar-Apr;10(2):134. doi: 10.1097/ADM.0000000000000192. No abstract available.
citation: Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
citation: National Institutes of Health, PROMIS tools for pain intensity and pain interference. http://www.healthmeasures.net/explore-measurement-systems/promis Last accessed on 03/02/2018.