EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications

Study Overview
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Brief Summary
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This is a 10-month internet-based randomized controlled trial to evaluate whether an online chronic pain management program (E-Health) can assist with reduced opioid reliance in chronic pain patients. About half of the eligible participants will receive access to the E-Health program in addition to their standard chronic pain treatment; the other half will just continue receiving their standard chronic pain treatment.

Detailed Description
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This study will determine whether an innovative, accessible E-health intervention can assist with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of unintended opioid overdose and death. Importantly, the study will contribute to a better understanding of the mechanisms contributing to opioid use reduction while managing pain. The findings may assist in developing treatment options for a population at risk for opioid adverse effects. Potential participants will be identified through electronic health record (EHR) queries at participating sites. Participants will be assessed at baseline, at the end of the 4-month treatment period, and at 6 months following end-of-treatment through an electronic data capture system accessed by the participants. Other outcome data will be obtained from the participant's EHR data.

Official Title
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EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: E-health program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 25-80 years of age Be able to understand the study, and having understood, provide informed consent in English Have a daily average prescribed MED ≥ 20 mg over a recent three-month period Have a chronic pain-related diagnosis Self-report current use of opioid medication(s) to treat pain Have a Brief Pain Inventory Pain Intensity score ≥3 Have internet access and a working email account Exclusion Criteria: Be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to change to a different primary care clinic, have a terminal illness, etc.) Be unwilling/unable to complete the WebNeuro assessments Be pregnant Be a prisoner

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment As Usual<br>Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study. | |
| Experimental: E-Health+<br>Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program. | Behavioral: E-health program<br>* The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Morphine Equivalent Dose (MED) | Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up. | Baseline and 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up. | Baseline and 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid therapy, web-based intervention, self-management