Clinical trial NCT03890263: Evaluating Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention
Official title: Evaluating the Outcomes and Experiences of Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention: a Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-03-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed description: Chronic pain is a burden on individuals, the health system, and society. Opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. Unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. Opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. One of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids.

Unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. Self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. Evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. 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. If effective, this approach could be implemented more widely. The results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic pain.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Chronic pain due to cancer

Primary outcomes:
measure: Changes in Opioid Use
timeFrame: Every 2 weeks for 36 weeks
measure: Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI)
timeFrame: Every 2 weeks for 36 weeks
measure: Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI)
timeFrame: Every 2 weeks for 36 weeks
measure: Occurrence of Adverse Events
timeFrame: Every 2 weeks for 36 weeks
Secondary outcomes:
measure: Adverse Childhood Experiences (ACE) Questionnaire
timeFrame: Baseline
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version
timeFrame: Baseline
measure: Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L)
timeFrame: Baseline
measure: Change in patient specific functional scale (PSFS)
timeFrame: Baseline, 12 weeks, 36 weeks
measure: Global Rating of Change in function (12-weeks)
timeFrame: 12-weeks
measure: Global Rating of Change in function (36-weeks)
timeFrame: 36 weeks
measure: Goal Attainment Scale (12-weeks)
timeFrame: 12-weeks
measure: Goal Attainment Scale (36-weeks)
timeFrame: 12-weeks and 36 weeks
measure: Satisfaction with care (12-weeks): 11-point scale
timeFrame: 12-weeks
measure: Satisfaction with care (36-weeks): 11-point scale
timeFrame: 36-weeks
Other outcomes:
Locations:
city: Belleville
country: Canada
facility: Queen's Family Health Team
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: