Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts
Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts
This study will demonstrate that functional improvement measures over a 6-month period for
 chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic
 plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those
 under the care of the PMS only. Chronic low back pain patient will be initially be evaluated
 by the PMS. 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. Patients will be randomized into one of the two groups: Group 1 - Subjects will be
 treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by
 their own PCP for monthly visits for 6 months.
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.

 Group 1 & 2: Subjects in both groups will undergo the following:

 1. Urine drug screening test (qualitative); includes amphetamines, barbiturates,
 benzodiazepines, cannabinoids, cocaine, ethanol, and opioids

 2. Receive a sample copy of an opioid contract/agreement

 3. PMS will query the Illinois prescription monitoring program for that patient to
 determine the various health care providers who are prescribing narcotics or other
 controlled medications.

 4. Undergo a psychological test and evaluation by the Rush University Pain Center
 psychologist (including the Screener and Opioid Assessment for Patients with
 Pain-Revised (SOAPP-R)13), to determine risk of drug abuse.

 Template for treatment of low back pain to be provided for PCP.

 This template is only a suggestion, and clinical and medical judgment for each patient will
 be decided by the PMS. Listed are the categories of pharmacological and non-pharmacological
 modalities, but the PMS will formulate a patient-specific prescriptive plan after evaluation
 at the initial work-up:

 1. Non-steroidal anti-inflammatory drugs (NSAIDs): preferably COX-2 inhibitor for all
 patients. If NSAIDs are prescribed, GI prophylaxis needs to be provided.14,15 This would
 be prescribed to all patients and will be provided daily and not 'as needed' medication,
 unless there are adverse events that prevent its administration.

 2. Muscle relaxants: such pharmacological agents include baclofen, tizanidine, or lorazepam
 to relieve painful muscle spasms16

 3. Opioids: long-acting opioids (oxycodone, controlled- release), short-acting opioids
 (e.g. hydrocodone/acetaminophen)14,15,17

 4. Anticonvulsants: mainly gabapentin or pregabalin18

 5. Transcutaneous electrical nerve stimulation (TENS) unit19 At the end of the 6-month
 treatment period (end of study), patients will be given the option to continue the
 treatment with their group or changing to any other treatment available.

 A research study nurse, blinded to group allocation, will call patients (from both groups)
 every month to collect BPI questionnaire responses over the phone. In addition, a general
 measure of functional health and well-being, the SF-36 health-related quality of life outcome
 measure (Short-Form 36 Health Survey), will be collected during the same call.21 The SF-36
 total score can be used as an overall health measure, or as a measure of two different health
 domains: physical health (including bodily pain) and mental health, as well as further
 division into more specific subscales. A baseline BPI and SF-36 will be obtained from each
 subject's initial visit record (EHR). The research study nurse will enter data obtained from
 the phone calls directly into the Rush University Pain Centers (RUPC) EHR on the
 eClinicalWorks platform.

 To evaluate procedural variations, side effects and secondary outcomes over the 6 month
 follow-up treatment period, a data integration clinical coordinator (DICC), not blinded to
 group allocation, will query electronic and physical health records, from both the PCP and
 PMS, as well as corresponding HIS's.
Inclusion Criteria:

 1.Non-structural non-specific chronic low back pain of a least 3 months duration

 2.18 years of age or older

 3.Has a primary care provider (PCP)

 Exclusion Criteria:

 1. Unable to communicate with health care providers

 2. Refuses to complete the required outcome measures

 3. Unable to provide consent

 4. Advanced medical illness (severe systemic disease)

 5. Significant psychiatric history: a diagnosis of schizophrenia, bipolar disorder, or
 severe depression.

 6. History of psychosis or psychiatric hospitalization, suicidal ideation or attempt.