Reducing Opioid Use for Chronic Pain Patients Following Surgery

Not Applicable

Recruiting

• Conditions: Opioid Use; Postoperative Pain; Chronic Pain; Opioid Dependence
• Interventions: Other: Interventional Group; Other: Control Intervention

• Registration Number: NCT03675386
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Study Start: 2018-09-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group	Interventional Group	Patients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
Pain interference	One year	Brief Pain Inventory Scale is a measure that assess the severity of pain and the impact of pain on daily functions. Measurement of this scale is rated on a 0-10 numerical-rating-scale ( 0= No Pain to 10= Pain as bad as you can imagine or 0= Does not interfere to 10= Completely interferes). The BPI assess pain at its worst, least, average, and now. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Portion of patients weaned off opioids	1 year	Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm

Trial Locations

Locations (1)

Toronto General Hospital- University Health Network; 🇨🇦 Toronto, Ontario, Canada