Improving Functional Outcomes and Lowering Health Care Costs by Enhanced Integration of Primary Care Providers and Pain Medicine Physicians for Chronic Non-cancer Pain Patients

In this trial, each chronic low back pain patient presenting to the Rush University Pain Center will initially be evaluated by the PMS.The initial evaluation visit, as part of the routine care for all new low back patients, will include the following: a full physical examination, review of medical health and medication history, and radiological imaging (EHR will be used for the study). In addition, all new patients will need to provide a urine drug screening test and will need to undergo psychological testing and evaluation.

A determination will be made by the PMS on whether the best treatment modality includes an interventional approach or non-interventional. If no interventional pain therapy is required, a multimodal therapeutic plan (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low back pain. A complete workup will be performed to accomplish this task.

If a non-interventional treatment (pharmacological and non-pharmacological) is selected, that can be implemented by a PCP, the patients will be informed of the study, and if interested, a Prescreening Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) form will be obtained from patient to give permission to contact their PCP. At that point, the patients' PCPs will be contacted, presented with the study information, and asked if they want to participate in the study. If the PCP agrees, the Main Study Informed Consent will be obtained from the patient. Patients meeting criteria would then be randomized into one of two treatment groups for continued treatment over the next 6 months. This initial multimodal therapeutic treatment can be altered by the respective treatment groups (PMS or PCP) to which study subject has been randomized.

Group 1 (PMS treatment): Subjects will continue to be followed for the next 6 months by the PMS (typically every month for the treatment of chronic pain) per standard protocol. The PCP will not be involved in the treatment.

Group 2 (PCP treatment): Subjects will be followed by the PCP for the next 6 months. The PCP will be involved using EHR and a multimodal therapeutic strategy will be communicated to the PCP by the PMS. The PCP will make dosage based on an algorithm provided by the PMS on how to adjust drug doses over time (general template-See below). It is not intended that the PCP may have ongoing engagement with the PMS. While the PCP may request clarification by the PMS during the first week of subject treatment, any further contact between the PCP and the PMS would result in the subjects being withdrawn from the study. In addition, a direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns. In case of serious medical events, the subject will be withdrawn from the study and appropriate medical care will be provided by the PMS or PCP.