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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890263
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jordan Miller, PT, PhD, Queen's University

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

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Chronic Pain Self-Management Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Outcomes and Experiences of Chronic Pain Self-Management Support With an Opioid De-prescribing Intervention: A Mixed Methods Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Opioid deprescribing and self-management Behavioral: Chronic Pain Self-Management Support

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.

Other Name: Opioid De-prescription




Primary Outcome Measures :
  1. Changes in Opioid Use [ Time Frame: Every 2 weeks for 36 weeks ]
    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.

  2. Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI) [ Time Frame: Every 2 weeks for 36 weeks ]
    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.

  3. Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI) [ Time Frame: Every 2 weeks for 36 weeks ]
    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.

  4. Occurrence of Adverse Events [ Time Frame: Every 2 weeks for 36 weeks ]
    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.


Secondary Outcome Measures :
  1. Adverse Childhood Experiences (ACE) Questionnaire [ Time Frame: Baseline ]
    The Adverse Childhood Experiences (ACE) Questionnaire will be used to identify adverse childhood experiences. It has shown good reliability and predictive validity. Several studies have demonstrated its ability to predict the onset of chronic pain in adults and it has been shown to be associated with initiation of opioid use, opioid dependence, opioid misuse, and likelihood of experiencing an opioid overdose. The questionnaire has 10 questions about various stressful childhood experiences. For each question an answer of No = 0 and and answer of Yes = 1. The total score out of 10 possible points will be used. This questionnaire will be administered only once at baseline.

  2. 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline ]
    The PHQ-9 demonstrates good reliability and validity and will be used to screen for depression using a cut-score of 10 points as has been suggested in the literature. The PHQ-9 has 9 questions, which all start with, "Over the past two weeks, how often have you been bothered by the following problem...:" The participant answers each one on a four-point Likert Scale, where 0 indicates not bothered at all and 3 indicates bothered nearly every day. The total score out of a possible 27 points will be used. This questionnaire will be administered only once at baseline to describe the population.

  3. Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version [ Time Frame: Baseline ]
    The PTSD Checklist - Civilian Version will be used to identify the presence and severity of post-traumatic stress symptoms. The checklist has 17 questions. The instructions begin with: "Below is a list of problems and complaints that people sometimes have in response to stressful life experiences. Please read each one carefully, then pick the answer that indicates how much you have been bothered by that problem in the last month." The answers are on a five-point scale, where 1 indicates not bothered at all and 5 indicates extremely bothered. The total severity score out of a possible 85 points will be used. A score range of 17-29 shows little to no severity; a score range of 28-29 shows some PTSD symptoms; a score range of 30-44 shows moderate to moderately high severity of PTSD symptoms; and a score range of 45-85 shows high severity of PTSD symptoms. This questionnaire will be administered only once at baseline to describe the population

  4. Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L) [ Time Frame: Baseline ]

    Health-related quality of life will be measured with the EuroQOL-5D (EQ-5D-5L). This questionnaire has two parts: the first is the 5-question 'descriptive system', which asks respondents to 'select the ONE statement that BEST describes your health TODAY' for 5 health dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. The 5 statements for each dimension are "no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5)". The 5 answers form a 5-digit code describing the respondent's 'health state'. Eg. the health state '12345' indicates no problems with mobility, slight problems with washing/dressing, moderate problems with usual activities, severe pain or discomfort and extreme anxiety or depression.

    The second part asks respondents to rate their global health today on a visual analogue scale from 0-100, where 100 means the best health imaginable and 0 means the worst health imaginable.


  5. Change in patient specific functional scale (PSFS) [ Time Frame: Baseline, 12 weeks, 36 weeks ]
    Changes in function will be measured with the Patient-Specific Functional Scale. Participants are asked to identify three important activities that they are having difficulty doing or are unable to do as a result of their primary condition. For each activity, they are asked to use an 11-point scale to rate their difficulty, where 0 indicates they are able to perform activity at the same level as before the injury or problem (No issues) and 10 indicates they are unable to perform activity (Cannot perform). The mean score will be used (sum of the activity scores divided by the number of activities). Minimum detectable change (90%CI) for average score = 2 points. The same activities will be rated at baseline, 12 weeks and 36 weeks, and the changes in mean scores between time points will be recorded.

  6. Global Rating of Change in function (12-weeks) [ Time Frame: 12-weeks ]
    Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points.

  7. Global Rating of Change in function (36-weeks) [ Time Frame: 36 weeks ]
    Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points.

  8. Goal Attainment Scale (12-weeks) [ Time Frame: 12-weeks ]
    Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks.

  9. Goal Attainment Scale (36-weeks) [ Time Frame: 12-weeks and 36 weeks ]
    Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks.

  10. Satisfaction with care (12-weeks): 11-point scale [ Time Frame: 12-weeks ]
    Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. This will be measured this at 12 weeks and 36 weeks.

  11. Satisfaction with care (36-weeks): 11-point scale [ Time Frame: 36-weeks ]
    Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. We will measure this at 12 weeks and 36 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890263


Contacts
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Contact: Jordan Miller, PhD 905-872-9938 jordan.miller@queensu.ca

Locations
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Canada, Ontario
Queen's Family Health Team Recruiting
Belleville, Ontario, Canada, K8N 2S9
Contact: Catherine Donnelly, PhD    613-533-6385    donnelyc@queensu.ca   
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Jordan Miller, PhD Queen's University
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Responsible Party: Jordan Miller, PT, PhD, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT03890263    
Other Study ID Numbers: 373022
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations