The treatment of chronic non-cancer pain has largely fallen to primary care physicians who often, due to healthcare system constraints, rely exclusively on long-term opioid therapy (LOT). Based on the adverse consequences and inadequate evidence of effectiveness for LOT, the CDC recently developed recommendations designed to decrease the use of LOT and the morphine equivalent dose (MED) for patients receiving LOT. However, the majority of people receiving LOT report that opioid medication is significantly beneficial and even critical to managing their pain. Compounding the problem is poor access to non- pharmacologic therapies for many patients, particularly in rural and lower socioeconomic communities, due to insurance reimbursement structures and limited availability of pain services. The importance of testing adjunctive therapies to reduce MED was noted in NIDA?s new strategic plan as was the importance of evaluating interventions that are scalable and, thus, more likely to be used. Chronic pain patients are increasingly using the internet for information and support; hence an affordable and effective web-based intervention could dramatically increase access to pain treatment. A web-based chronic pain program, the Chronic Pain Management Program (referred to as E-health), includes multiple learning centers that train skills such as cognitive restructuring, emotion regulation, goal setting, activity and exercise promotion, social support, relaxation techniques, and behavioral activation. The learning activities can be completed within a 4- month subscription period, the cost of which is $25/month. The results of two prior randomized controlled trials (RCTs) found E-health to be efficacious in decreasing pain and medication use. While these results are promising, they need to be replicated in a larger RCT and with patients being treated in primary care, where the majority of chronic pain patients are treated.
Specific aims for the present project are to: 1) Conduct a RCT comparing E-health+ to treatment as usual (TAU). Four hundred patients being treated with ?20 mg/day MED for chronic pain at primary care practices within one of two healthcare systems will be randomized in a 1:1 ratio to TAU or to TAU plus E-health (E-health+). TAU will consist of LOT from a primary care physician; MED and physician visits will be tracked through the electronic health record (EHR). TAU will be further characterized using the Assessment of Chronic Illness Care, which assesses the degree to which a practice uses six strategies that encourage high-quality care. Participants will complete assessments at baseline, the end of the 4-month E-health treatment period, and at 6 months post-treatment. 2) Test our conceptual model of E-health?s mechanisms of change, including hypothesized mediators (i.e., pain self-efficacy, coping strategies, knowledge about pain/opioid therapy, and stress) and moderators (neurocognitive function: executive function and verbal learning ability) of E-health?s impact on decreasing MED and pain intensity.

Public Health Relevance

The alarming increase in adverse effects related to the use of long-term opioid therapy (LOT) as a primary treatment for chronic non-cancer pain, including overdoses and addiction, has increased awareness of the need for treatments that can reduce morphine equivalent dose (MED) while still effectively managing pain. This project will evaluate a web-based chronic pain management program (E-health) that has been found to reduce MED, while also decreasing pain, in two small randomized controlled trial (RCTs). The proposed RCT, to be conducted with 400 chronic pain patients receiving LOT in primary care at one of two healthcare systems, will compare the impact of E-health, relative to treatment as usual alone, on MED and pain outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA044248-03
Application #
9724431
Study Section
Special Emphasis Panel (ZDA1)
Program Officer
Su, Shelley
Project Start
2017-09-01
Project End
2022-06-30
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Cincinnati
Department
Psychiatry
Type
Schools of Medicine
DUNS #
041064767
City
Cincinnati
State
OH
Country
United States
Zip Code
45221