- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484937
Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Urine drug screening test (qualitative); includes amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ethanol, and opioids
- Receive a sample copy of an opioid contract/agreement
- 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.
- 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:
- 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.
- Muscle relaxants: such pharmacological agents include baclofen, tizanidine, or lorazepam to relieve painful muscle spasms16
- Opioids: long-acting opioids (oxycodone, controlled- release), short-acting opioids (e.g. hydrocodone/acetaminophen)14,15,17
- Anticonvulsants: mainly gabapentin or pregabalin18
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Unable to communicate with health care providers
- Refuses to complete the required outcome measures
- Unable to provide consent
- Advanced medical illness (severe systemic disease)
- Significant psychiatric history: a diagnosis of schizophrenia, bipolar disorder, or severe depression.
- History of psychosis or psychiatric hospitalization, suicidal ideation or attempt.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 (PMS Treatment)
Subjects will be treated monthly for 6 months by Pain Medicine Specialist (PMS) per standard protocol.
The PCP will not be involved in the treatment.
|
For the PMS group treatment will be performed (pain treatment/medications) by the Pain Medicine Specialist in his/her office/clinic.
|
Experimental: Group 2 (PCP Treatment)
Subjects will be treated monthly for 6 months by the Primary Care Provider (PCP).The PCP will be involved 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.
It is not intended that the PCP may have ongoing engagement with the PMS.
A direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns.
|
For the PCP group treatment will be performed (pain treatment/medications) by the Primary Care Physician in his/her office/clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain interference with daily activity - BPI score change from baseline.
Time Frame: 6 months
|
The Brief Pain Inventory (BPI) short form is a self-report questionnaire using items (questions) on a 11-point scale (0-10), and will be used to assess impact of pain on daily activities, and pain severity. We will gather data approximately on a monthly basis (Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month). |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural variations
Time Frame: 6 months
|
A data integration clinical coordinator (DICC), not blinded to group allocation, will query electronic and physical health records, from both the PCP and PMS
|
6 months
|
Functional health and well-being - improvement from baseline
Time Frame: 6 months
|
The Short Form-36 Health Survey (SF-36) form is a health-related quality of lif questionnaire which measures two different health domains: physical health (including bodily pain) and mental health, as well as further division into more specific subscales.
|
6 months
|
Patients experience of care
Time Frame: 6 months
|
The Patient Satisfaction Questionnaire (PSQ-18) assesses global satisfaction with medical care as well as satisfaction with six aspects of care: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility of care
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14100602
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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