Evaluating Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention

NCT03890263 | Completed

• 1 other identifier: 373022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Changes in Opioid Use

  Changes in opioid use will be measured using milligram morphine equivalents per day. This will be collected every two weeks throughout the 36-week study period.

  Every 2 weeks for 36 weeks

• Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI)

  Changes in pain severity will be measured using the Pain Severity Scale of the Brief Pain Inventory (BPI), which asks about the participant's pain at its worst, at its best, on overage and right now. It uses an 11-point scale ranging from 0 to 10, where 0 indicates no pain at all and 10 indicates the worst pain imaginable. The mean severity of all four individual scores will be used for the main analysis (total of all four scores divided by four). Pain severity will be assessed every two weeks, measuring the change across the course of the study.

  Every 2 weeks for 36 weeks

• Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI)

  Changes in pain interference will be measured with the Pain Interference Scale of the Brief Pain Inventory (BPI), which uses an 11-point scale to measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. On the scale, 0 indicates that pain has not interfered with the activity at all and 10 indicates that pain has completely interfered with the activity. BPI Pain Interference will scored as the mean of the scores on seven interference items (total of all seven scores divided by seven). Pain interference will be assessed every two weeks, measuring the change across the course of the study.

  Every 2 weeks for 36 weeks

• Occurrence of Adverse Events

  Occurrence adverse events over a 36 week period will be recorded using an adverse events questionnaire that is consistent with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) what adverse events were experienced (choose from a drop-down list or 'other'); 3) how long the event lasted (hours or days); 4) How severe the adverse event was (0-10 scale, where 0 indicates not severe at all and 10 indicates very severe). Each occurrence (the type of adverse event and duration and severity) will be recorded individually for reporting purposes as well as descriptive purposes.

  Every 2 weeks for 36 weeks

Secondary Outcomes (11)

• Adverse Childhood Experiences (ACE) Questionnaire

  Baseline

• 9-item Patient Health Questionnaire (PHQ-9)

  Baseline

• Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version

  Baseline

• Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L)

  Baseline

• Change in patient specific functional scale (PSFS)

  Baseline, 12 weeks, 36 weeks

Study Arms (1)

Opioid deprescribing and self-management

EXPERIMENTAL

Behavioral: Chronic Pain Self-Management Support

Interventions

Chronic Pain Self-Management Support BEHAVIORAL

Family physicians and nurse practitioners will participate in an academic detailing session with a pharmacist that focuses on safe, evidence-based opioid deprescribing. The pharmacist will provide pre-visit recommendations for each visit with a person on high doses of opioids. The pharmacist and healthcare providers will develop a patient centered, opioid taper schedule, with follow-up at 2 to 4 week intervals to assess for efficacy and safety. The self-management intervention will be "Chronic Pain Self-management Support with Pain Science Education and Exercise" (COMMENCE), which consists of 2 visits per week over 6 weeks. One visit per week is 1.5 hours in a group format. with education about self-management and pain science as well as cognitive behavioural principles. The 2nd visit each week is 30 minutes in a one-to-one format and is individually tailored to support implementation of self-management plans and development of an exercise program.

Also known as: Opioid De-prescription

Opioid deprescribing and self-management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain for \>3months
• On opioid medications with a dose of at least 50 milligram morphine equivalents per day
• Ability to communicate effectively using the English language, including reading and writing

You may not qualify if:

• \- Chronic pain due to cancer

Sponsors & Collaborators

• Queen's University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Queen's Family Health Team

Belleville, Ontario, K8N 2S9, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will use parallel mixed methods including: 1. An interrupted time series design to evaluate outcomes of an evidence-based self-management intervention and opioid deprescribing. This time series will include 18 assessments over 36-weeks from 12 weeks prior to implementation of the combined intervention to 24 weeks after implementation of the combined intervention. 2. Qualitative semi-structured interviews informed by an interpretive description approach with patients and health care providers to understand their perspectives and experiences. 3. A nested cross sectional evaluation to determine the characteristics of people who are identified on high doses of opioids in primary care in South Eastern Ontario. Characteristics collected will include: age, sex, gender, education, household income, postal code/geographic location, work status, caregiver status, early childhood trauma, depression, post-traumatic stress, health-related quality of life, and comorbidities.

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: July 1, 2019
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)