Clinical trial NCT03308188: EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Opioid therapy
web-based intervention
self-management
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-10-12
Enrollment: 402
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Morphine Equivalent Dose (MED)
timeFrame: Baseline and 10 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline and 10 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: