Clinical trial NCT02513836: Opioid Safety Program in Pain Clinics (Op-Safe):
Official title: Development of an Innovative Opioid Safety Program in Pain Clinics (Op-Safe): A Multi-Centre Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Keywords: opioids
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive performance of screening algorithm for sleep disordered breathing
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehab Institute (TRI)
state: Ontario
city: Toronto
country: Canada
facility: Women's College hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Wasser pain management clinic
state: Ontario
Study officials:
References:
citation: Selvanathan J, Waseem R, Peng P, Wong J, Ryan CM, Chung F. Simple screening model for identifying the risk of sleep apnea in patients on opioids for chronic pain. Reg Anesth Pain Med. 2021 Oct;46(10):886-891. doi: 10.1136/rapm-2020-102388. Epub 2021 Aug 9.
citation: Wasef S, Mir S, Ryan C, Waseem R, Bellingham G, Kashgari A, Wong J, Chung F. Treatment for patients with sleep apnea on opioids for chronic pain: results of the OpSafe trial. J Clin Sleep Med. 2021 Apr 1;17(4):819-824. doi: 10.5664/jcsm.9064.
citation: Chung F, Wong J, Bellingham G, Lebovic G, Singh M, Waseem R, Peng P, George CFP, Furlan A, Bhatia A, Clarke H, Juurlink DN, Mamdani MM, Horner R, Orser BA, Ryan CM; Op-Safe Investigators. Predictive factors for sleep apnoea in patients on opioids for chronic pain. BMJ Open Respir Res. 2019 Dec 23;6(1):e000523. doi: 10.1136/bmjresp-2019-000523. eCollection 2019.