Chronic pain is associated with substantial suffering and other co-morbidities such as depression, insomnia, fatigue, lowered mobility, and worse quality-of-life. Most of the care of chronic pain patients occurs during hurried primary care visits with pharmacological treatments (e.g. opioids and medications) despite mixed evidence of efficacy and increased risk of potentially dangerous side effects, including addiction and death. Even when these treatments are effective in reducing pain, they may not improve mental and functional status and may actually increase depression. The need for easy access to evidence-based non-pharmacological treatment options that include patient information and skill building would be helpful to chronic pain patients. To address this need for non-pharmacological approaches to treating chronic pain, we propose developing the GEMINI platform to facilitate the delivery of online Integrative Medical Group Visits (IMGV) via video conferencing with evidence-based home practice/self-management tools covering such topics as mindfulness, mind body practices, self-management of chronic pain, stress reduction, sleep, and nutrition. GEMINI includes two primary components: 1) online group visit sessions and 2) online mind body home practice activities between sessions. GEMINI will allow the online delivery of the medical group visit via video conferencing, eliminating a major access barrier for patients with physical and/or practical limitations, which prohibits attending weekly in-person sessions. Between the online sessions, patients will use GEMINI for mind body home practice with the ability to select evidence-based self-care practice options based on their own preferences and symptoms, and to gain peer support from group-based activities. GEMINI will also have a Provider Portal to facilitate the management of online sessions, the maintenance of course content, and the tracking of patient progress. Phase I aims are: 1) Collect stakeholder feedback from chronic pain patients and primary care providers via focus groups; 2) Develop the GEMINI prototype using user-centered design and latest mobile-friendly technologies; 3) Evaluate GEMINI?s Patient Portal via two rounds of usability tests; and 4) Evaluate GEMINI?s Provider Portal with another round of usability test. The success criteria will be based on system usability, usefulness, and acceptability. The expected benefits of GEMINI include reduced pain impact, better pain- related patient outcomes, improved self-efficacy in pain management, and reduced opioid use. Dr. Gardiner?s (MPI) prior work has provided preliminary evidence of such benefits. We will validate these hypotheses with a randomized controlled trial in Phase II.

Public Health Relevance

Depression is common, affecting 27% of people in the US, and is recognized as an important risk factor for poor outcomes among patients with chronic illness. Many patients with depression also have chronic pain. Among adult patients with chronic pain, high levels of depression may worsen pain and pain-related disability. These conditions have overlapping neurophysiological processes, which complicate the treatment outcomes. In the face of the over prescribing of opioids, there is a strong need for non-pharmacological approaches to chronic pain management in those with active depression. To address this need for non-pharmacological approaches to treating chronic pain with active depression, we propose to develop the GEMINI platform to facilitate the delivery of Integrative Medicine Group Visit (IMGV) intervention model with online IMGV sessions and evidence-based home practice/self-management tools. The IMGV model incorporates the concepts of medical group visits and mindfulness-based stress reduction. We hypothesize that the use of the GEMINI intervention would result in reduced depression, reduced pain impact, better pain-related patient outcomes, improved self-efficacy in self management, and reduced opioid use.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AT010460-01
Application #
9778307
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Mudd, Lanay Marie
Project Start
2019-07-15
Project End
2020-07-14
Budget Start
2019-07-15
Budget End
2020-07-14
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Brightoutcome Inc.
Department
Type
DUNS #
141256797
City
Buffalo Grove
State
IL
Country
United States
Zip Code
60089