NCT03675386

Reducing Opioid Use for Chronic Pain Patients Following Surgery

Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Opioid Use
• Postoperative Pain
• Opioid Dependence

Interventions

Type	Name	Description
OTHER	Interventional Group	The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance \& Commitment Therapy (ACT) and e-mobile self-management tools.
OTHER	Control Intervention	Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.

Timeline

• Start date: 2018-09-24
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2018-09-18
• Last updated: 2024-03-21

Locations

1 site across 1 country: Canada