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

University of Cincinnati

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: E-health program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03308188

1R01DA044248-01 (U.S. NIH Grant/Contract)

2017-2301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

Treatment As Usual

No Intervention group

Description:

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.

E-Health+

Experimental group

Description:

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.

Treatment:

Behavioral: E-health program