24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery

NCT04043143 | Completed Results

• 2 other identifiers: 18-2098K23DA040923
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use

Keywords

opioids

Outcome Measures

Primary Outcomes (1)

• Prescribed Post-discharge Opioids

  Prescribed post-discharge opioid doses in oral morphine equivalents from the electronic health record (EHR).

  Date of admission to the hospital up to 60 days after the date of hospital discharge.

Secondary Outcomes (8)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1

  One week after hospital discharge date.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2

  Two weeks after hospital discharge date.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3

  Three weeks after hospital discharge date.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4

  Four weeks after hospital discharge date.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1

  One week after hospital discharge date.

Study Arms (2)

Arm 1 Prescription As Usual

PLACEBO COMPARATOR

At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.

Other: Arm 1 Prescription As Usual

Arm 2 Prescription Tool Intervention

EXPERIMENTAL

At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool 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 less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked.

Other: Arm 2 Prescription Tool Intervention

Interventions

Arm 1 Prescription As Usual OTHER

At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.

Arm 1 Prescription As Usual

Arm 2 Prescription Tool Intervention OTHER

The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.

Arm 2 Prescription Tool Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (8)

• 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.

  PMID: 26824844 BACKGROUND

• 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.

  PMID: 28594763 BACKGROUND

• 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.

  PMID: 29238810 BACKGROUND

• 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.

  PMID: 24758595 BACKGROUND

• 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.

  PMID: 29627407 BACKGROUND

• 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.

  PMID: 26985647 BACKGROUND

• 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.

  PMID: 29198638 BACKGROUND

• 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.

  BACKGROUND

Results Point of Contact

• Title: Karsten Bartels, MD, PhD, MBA
• Organization: University of Colorado Denver | Anschutz

karsten.bartels@cuanschutz.edu

303-724-1111

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators will use an electronic randomization scheme created so that the principal investigator and statistician can remain blind to assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: August 2, 2019
• Study Start: October 24, 2019
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)