University of Massachusetts Medical School Faculty Publications
Title
The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain
UMMS Affiliation
Department of Family Medicine and Community Health; Center for Integrated Primary Care
Publication Date
2021-10-01
Document Type
Article
Disciplines
Alternative and Complementary Medicine | Movement and Mind-Body Therapies | Pain Management | Primary Care | Telemedicine
Abstract
Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.
Keywords
Chronic low back pain, Medical group visits, Mindfulness meditation, Online intervention, Quadruple aim
DOI of Published Version
10.1016/j.cct.2021.106545
Source
Greco CM, Gaylord SA, Faurot K, Weinberg JM, Gardiner P, Roth I, Barnhill JL, Thomas HN, Dhamne SC, Lathren C, Baez JE, Lawrence S, Neogi T, Lasser KE, Castro MG, White AM, Simmons SJ, Ferrao C, Binda DD, Elhadidy N, Eason KM, McTigue KM, Morone NE. The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. Contemp Clin Trials. 2021 Oct;109:106545. doi: 10.1016/j.cct.2021.106545. Epub 2021 Aug 27. PMID: 34455111. Link to article on publisher's site
Related Resources
Journal/Book/Conference Title
Contemporary clinical trials
PubMed ID
34455111
Repository Citation
Greco CM, Gaylord SA, Faurot K, Weinberg JM, Gardiner PM, Roth I, Barnhill JL, Thomas HN, Dhamne SC, Lathren C, Baez JE, Lawrence S, Neogi T, Lasser KE, Castro MG, White AM, Simmons SJ, Ferrao C, Binda DD, Elhadidy N, Eason KM, McTigue KM, Morone NE. (2021). The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. University of Massachusetts Medical School Faculty Publications. https://doi.org/10.1016/j.cct.2021.106545. Retrieved from https://escholarship.umassmed.edu/faculty_pubs/2119