Opioid Safety Program in Pain Clinics (Op-Safe):

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing
• Interventions: Other: Post-education intervention; Other: Pre-education intervention

• Registration Number: NCT02513836
• Lead Sponsor: University Health Network, Toronto

Brief Summary

In this vital study, the investigators will develop an innovative Opioid Safety (Op-Safe) Program for use in pain clinics. The Op-Safe Program consists of two key components: Educating patients with an informative brochure and video developed by the Institute for Safe Medication Practices (ISMP) Canada, and a screening algorithm to identify unrecognized sleep apnea in patients taking opioids for chronic non-cancer pain.

Detailed Description

This 2-year prospective multi-centre cohort study will be conducted at chronic pain clinics at Women's College Hospital (WCH), Toronto Western Hospital (TWH), Toronto Rehab Institute (TRI), Mount Sinai Hospital (MSH) in Toronto, and St. Joseph's Hospital (SJH) in London, Ont.

The primary aim is to develop and evaluate an Obstructive Sleep Apnea (OSA) screening algorithm against the results of polysomnography.The research assistants will approach all patients visiting chronic pain clinics for eligibility. For recruited patients, a written informed consent will be obtained. All recruited patients will undergo polysomnography at the Toronto Rehab Institute Sleep Lab or Toronto Sleep and Pulmonary Centre. An overnight oximetry by an oximeter will be collected. The sleep physician will review the polysomnography results.

All recruited patients will also complete the STOP-Bang questionnaire and Epworth Sleepiness Scale (ESS). The thyromental distance, Mallampati classification, Friedman staging,neck circumference and oxygen saturation will be measured. Demographic data, co-morbidities, medications and an overnight oximetry will be collected.

Patients will be assessed on their opioid-related knowledge via the Patient Opioid Education Measure (POEM) at the first visit. They will be educated on knowledge of opioids via education sheet, pamphlet and video from ISMP-Canada, and then repeat Patient Opioid Education Measure (POEM) 6- 8 months later during pain clinic follow up visit.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-03
• Primary Completion: 2018-12
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• All adult patients (≥18 years old) with cognitive capability to comprehend the educational intervention who are taking opioid medication for >3 months for non-cancer pain.

Exclusion Criteria

1. Patients with chronic pain secondary to a neoplasm or metastasis as goals of care are different in this patient population.
2. Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines[60] e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, pulmonary hypertension, hypercapnic respiratory failure or pregnancy.
3. Conditions potentially interfering with comprehension and delivery of informed consent or the educational intervention, such as neurological or psychiatric disorders.
4. Patients with a prior diagnosis of sleep-related breathing disorder within the last 3 years with treatment. Patients who may have had sleep studies 3 or more years earlier may be included, if they have been lost to follow-up by a sleep physician, are not on treatment or are non-compliant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-education intervention	Post-education intervention	All study participants will be educated on opioids via an education sheet, pamphlet and video from the Institute for Safe Medication Practices (ISMP) Canada. They will repeat the questionnaire (POEM) after this education on opioid knowledge on the same day.
Pre-education intervention	Pre-education intervention	All study participants will be tested with a questionnaire (POEM; Patient Opioids Education Measurement) on their opioid knowledge during 1st visit at the pain clinic.

Primary Outcome Measures

Name	Time	Method
Predictive performance of screening algorithm for sleep disordered breathing	30 days	Predictive performance (sensitivity, specificity, positive predictive value, negative predictive value, and the area under receiver operating characteristic \[ROC\] curve) of screening algorithm for sleep disordered breathing. A paired t-test will be used to evaluate the changes in opioid related knowledge.

Trial Locations

Locations (5)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Mount Sinai Hospital, Wasser pain management clinic; 🇨🇦 Toronto, Ontario, Canada

Toronto Rehab Institute (TRI); 🇨🇦 Toronto, Ontario, Canada

Women's College hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia; 🇨🇦 Toronto, Ontario, Canada