Clinical trial NCT03675386: Reducing Opioid Use for Chronic Pain Patients Following Surgery
Official title: Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use
Postoperative Pain
Opioid Dependence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.

Detailed description: The proposed research program encompasses several study designs to evaluate the effectiveness and potential implementation of the TPSP across Ontario. The investigators will use three approaches to create a comprehensive evidence-base that can be used to guide future policy and programs related to the management of surgical patients with complex pain and chronic opioid use. In the first phase, a multicenter randomized controlled trial will be conducted in 6 hospital sites to evaluate the effectiveness and potential implementation of TPSP across Ontario. The aim is to recruit a total of 210 patients who are currently taking opioids and also undergoing a surgical intervention. The randomized controlled trial will determine the effectiveness of the TPSP at weaning patients completely off opioids while still managing pain after one year. Secondly, an economic and healthcare utilization analysis of the program via linkage to provincial administrative databases will be carried out to understand the impact the TPSP program has on the healthcare system as a whole. Lastly, a qualitative study will be conducted on both the treatment and control groups. The investigators hope to capture further insight to understand patients and providers experiences of the TPSP intervention.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Taking 20 -- 200 mg of preoperative oral morphine equivalents daily
* Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
* Able to read and understand English as posed on the questionnaire surveys prior to informed consent
* Must be taking opioids for at least one month prior to their operation
* Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool

Exclusion Criteria:

• Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial

Primary outcomes:
measure: Portion of patients weaned off opioids
timeFrame: 1 year
measure: Pain interference
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital- University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Karim Ladha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital, University Health Network
name: Hance Clarke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Centre
name: Elaheh Adly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Paul Tumber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rouge Valley Medical Centre
name: Anton Marinov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thunder Bay Reginal Health Sciences Centre
name: Melanie Toman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thunder Bay Reginal Health Sciences Centre
name: Yuvaraj Kotteeswaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Duminda Wijeysundera, MD
role: PRINCIPAL_INVESTIGATOR
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