Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM)

• ClinicalTrials.gov Identifier: NCT03953534
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2019
• Last Update Posted: March 9, 2023
• Sponsor: Hopital du Sacre-Coeur de Montreal
• Collaborators: Queen's University; Maisonneuve-Rosemont Hospital; Sunnybrook Health Sciences Centre; Hopital de l'Enfant-Jesus
• Information provided by (Responsible Party): Raoul Daoust, Hopital du Sacre-Coeur de Montreal

Tracking Information

• First Submitted Date: May 10, 2019
• First Posted Date: May 16, 2019
• Last Update Posted Date: March 9, 2023
• Actual Study Start Date: May 6, 2019
• Estimated Primary Completion Date: April 27, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2019)

Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition [ Time Frame: During 14 days ]

This will allow us to define the quantity of opioids needed to manage acute pain while limiting the quantity of unused pills available for potential misuse.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 15, 2019)

• Quantity of opioids prescribed to ED-discharged patients treated for different acute pain conditions [ Time Frame: Baseline ]
  From physicians' prescriptions
• Quantity of opioids to sufficiently supply a given percentage of patients for each pain condition [ Time Frame: During 14 days ]
  Patient's questionnaire after 2 weeks and 14-diary on opioids consumption.
• Quantity of unused opioids [ Time Frame: At day 14 ]
  Patient's questionnaire after 2 weeks
• Quantity of patients that filled (initial or other) opioid prescriptions [ Time Frame: At day 14 ]
  Patient's questionnaire after 2 weeks
• Quantity of patients using of coanalgesics or other substances (alcohol, cannabis…) to manage pain [ Time Frame: During 14 days ]
  Patient's questionnaire after 2 weeks
• Qualitative evaluation of the participants' reasons for stopping opioid consumption [ Time Frame: During 14 days ]
  Patient's questionnaire after 2 weeks
• Incidence and type of medication side effects during the 2-week period [ Time Frame: During 14 days ]
  Patient's questionnaire after 2 weeks
• Quantity of patients who revisit health services to obtain new prescription [ Time Frame: During 14 days ]
  Patient's questionnaire after 2 weeks
• Quantitive validation of the patients' self-report opioid consumption [ Time Frame: At day 14 ]
  Comparison of self-report comsumption and in person pill count after 2 weeks
• Group-based trajectory modeling to determine pain intensity trajectory for each pain condition during the acute phase [ Time Frame: During 14 days ]
  After 2 weeks. Average pain intensity for each patient will be measured using a 0-10 numerical rating scale for each of the 14-day diary. Group-based trajectory modeling will then be used to identify groups of patients with similar pattern of pain evolution over time without assuming the existence of a specific trend or number of groups.
• Evaluate the chronic pain prevalence at 3 months among study participants assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later. [ Time Frame: 3 months ]
  After 90 days. Chronic pain will be defined as a pain intensity score at 3-month of >=4 and with moderate or severe functional disability using the pain disability index score (>40).
• Assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later [ Time Frame: 3 months ]
  Pain intensity trajectories after 14 days and chronic pain at 3 months. Average pain intensity for each patient will be measured using a 0-10 numerical rating scale for each of the 14-day diary. Group-based trajectory modeling will then be used to identify groups of patients with similar pattern of pain evolution over time without assuming the existence of a specific trend or number of groups. Chronic pain will be defined as a pain intensity score at 3-month of >=4 and with moderate or severe functional disability using the pain disability index score (>40).

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 15, 2019)

• Qualitative evaluation of participant's opioids storage and disposal [ Time Frame: At day 14 ]
  Patient's questionnaire after 2 weeks
• Evaluate the participants' perception of opioid analgesia (patient, physician, nurse, and pharmacist) with a likert scale type survey [ Time Frame: Baseline ]
  Survey with Likert style questions administered before start of recruitment

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Quantity of Opioids for Acute Pain and Limit Unused Medication
• Official Title: Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM Study)

Brief Summary

Opioids (morphine and morphine-like substances) are often prescribed to patients to manage pain after an emergency department visit. In the past 20 years, opioid prescriptions have risen sharply, accompanied by a significant rise in opioid misuse (e.g., recreational or non-medical use, potentially leading to addiction or overdose). One explanation for this crisis is the availability and easy access of leftover opioid pills in Canadian homes, allowing family members (including children) and friends to take them for reasons other than pain relief.

Canada has no recommendations for the dosage, duration, or quantity of opioids that physicians should prescribe to manage acute pain at home. Physicians are therefore left guessing as to how much to prescribe when a patient with a condition like a fracture or renal colic is discharged from the emergency department. Our preliminary study showed that two-thirds of the pills from the initial opioid prescription to treat acute pain actually remained unused and were therefore available for potential misuse.

The investigators propose to determine how many opioid pills are consumed by patients who suffer from acute pain as they recover at home. The investigators will ask 2,560 patients (from 6 Canadian hospitals) to record their pain medication consumption in a 14-day diary. The investigators will also determine, their pain intensity level, whether or not they had new opioid prescriptions, and health services revisits. In case of missing information, patients will be contacted by phone at 2 weeks. The overall aim is to help emergency department physicians prescribe the right number of pills in order to manage patients' pain and at the same time reduce substantially leftovers available for potential misuse.

Detailed Description

Introduction

Prescription opioid overdoses have quadrupled in the last 15 years, and are now the leading cause of accidental death, surpassing motor vehicle accidents. The drastic rise in opioid prescription rates in Canada and the US could be the driving force behind this higher mortality. It was shown that 71% of opioid misusers (i.e., intentional users for nonmedical purposes) received their drugs through the diversion of unused prescribed opioids (transfer of opioids to someone other than the holder of the initial prescription). Emergency department (ED) physicians are among the top opioid prescribers for patients under 40, and there are currently no prospective studies on how many opioid pills should be prescribed to patients discharged from the ED with common pain conditions in order to limit unused pills. Preliminary results from our group revealed that two-thirds of the total prescribed opioids were not consumed and remained available for misuse.

Objectives

The ultimate goal of this research program is to decrease opioid misuse by lowering the quantity of unused medications. The primary objective of this project is to determine the quantity of opioids consumed during the acute pain phase (2 weeks) by ED-discharged patients treated for an acute pain condition. The secondary objectives are to inventory the quantity of opioids prescribed and unused after ED visits, use of co-analgesics, pain intensity, health services revisits during the 2-week follow-up, and chronic pain prevalence at 3 months.

Methods

The investigators propose a multicentre prospective observational cohort study in 2,560 consecutive ED patients recruited from 6 Canadian hospitals. The study will include patients aged ≥18 years, treated for an acute pain condition present for less than 2 weeks (usual acute pain definition), and discharged from the ED with an opioid prescription. Pain at triage and at ED discharged, diagnosis, and complete pain medication prescription will be initially listed. Patients will complete a 14-day electronic diary using the REDCap web-based system to document their daily pain medication consumption, pain intensity, new opioid prescriptions, and health services revisits. Patients will also answer questionnaires at 2 weeks and 3 months for our various secondary objectives. To validate the patient self-report opioid consumption, a randomized subset of patients will come back to the emergency for a follow-up visit and a manual count of the remaining opioids. As mitigation strategies (validated in our pilot study), non-responders to the diary will be contacted by phone at 2 weeks to answered questions summing diary information, and paper versions will be available for patients without Internet access.

Sample size estimation

The sample size was calculated to obtain an accurate estimate of the mean quantity of 5 mg morphine pill equivalent that patients will consume during the first 2 weeks after ED visit for each pain condition (primary objective). Our preliminary study was used to determine the standard deviation of opioids consumed after discharge from ED (SD=16). To estimate the mean 5 mg morphine pill equivalent consumed for each of the five pain conditions (acute back pain, fracture, sprain/contusion, renal colic, and other) with a 95%CI margin of error of 1.5 pills (or ~10% of the SD) with a standard deviation of 16 pills, each diagnostic category requires 440 patients. With the 14% attrition rate observed during our pilot study at two weeks, a total of 2,560 patients will be recruited (512 patients - 72 lost to follow-up = 440 patients per pain condition). Sample size calculations were performed using PASS (Power Analysis & Sample Size software, version 11.0: NCSS Statistical Software).

Feasibility

The investigators demonstrated the study feasibility in a successful pilot study with 627 patients at our academic ED. Additionally, our project brings together a committed, multidisciplinary research team, and all proposed study sites have collaborated previously on large multicentre studies. Finally, all instruments have been successfully tested, allowing rapid study implementation.

Impact

Our results will determine the quantity of opioids consumed during the acute pain phase (2 weeks) to ED-discharged patients treated for acute pain conditions. Our team members from relevant provincial and national stakeholders and patient associations, our strong evidence, and our extensive knowledge transfer strategy have the potential to impact physicians' opioid prescription practices. Consequently, fewer unused prescription opioids should lead to a substantial decrease in the currently high rate of opioid misuse.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

A cohort of consecutive ED patients aged 18 years or more, treated for an acute pain condition present for less than 2 weeks (usual acute pain definition),and discharged with an opioid prescription will be included.

In accordance to our pragmatic approach, we will exclude only patients with current use of opioids or chronic pain medication for a pre-existing condition or disease (e.g., cancer), because opioid dosage and/or pain mechanisms differ in these circumstances.

• Condition: Acute Pain
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Daoust R, Paquet J, Williamson D, Perry JJ, Iseppon M, Castonguay V, Morris J, Cournoyer A. Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study. BMJ Open. 2022 Oct 28;12(10):e062984. doi: 10.1136/bmjopen-2022-062984. Erratum In: BMJ Open. 2022 Nov 15;12(11):e062984corr1.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 10, 2022): 2560
• Original Estimated Enrollment (submitted: May 15, 2019): 2580
• Estimated Study Completion Date: April 27, 2023
• Estimated Primary Completion Date: April 27, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Opioid prescription at discharge
• Acute pain for less than 2 weeks

Exclusion Criteria:

• Language barrier
• Chronic pain under treatment
• Active Neoplasia
• Follow-up impossible / Unable to complete agenda
• Already on opioids

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

Gender Eligibility Description

The patient's sex/gender may have an incidence on the quantity of opioids consumed. We will also look if there are sex/gender differences in the quantity of opioids prescribed and unused, in pain trajectory, in reasons for stopping opioids, and access to the health care system.

The patient gender will be self-reported in the electronic diary (or paper version) using the following multiple choice question.

To which gender identity do the participant most identify?

• Female
• Male
• Transgender Female
• Transgender Male
• Other
• Prefer Not to Answer

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03953534
• Other Study ID Numbers: 2019-1684; PJT-159808 ( Other Grant/Funding Number: CIHR )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Raoul Daoust, Hopital du Sacre-Coeur de Montreal
• Original Responsible Party: Same as current
• Current Study Sponsor: Hopital du Sacre-Coeur de Montreal
• Original Study Sponsor: Same as current

Collaborators

• Queen's University
• Maisonneuve-Rosemont Hospital
• Sunnybrook Health Sciences Centre
• Hopital de l'Enfant-Jesus

Investigators

• Principal Investigator: Raoul Daoust, MD MSc; Université de Montréal

• PRS Account: Hopital du Sacre-Coeur de Montreal
• Verification Date: March 2023