Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts

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.