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

NCT02484937 | Terminated

• 1 other identifier: 14100602
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Chronic Pain; Pain, Intractable

Keywords

Pain management

Outcome Measures

Primary Outcomes (1)

• Pain interference with daily activity - BPI score change from baseline.

  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 Outcomes (3)

• Procedural variations

  6 months

• Functional health and well-being - improvement from baseline

  6 months

• Patients experience of care

  6 months

Study Arms (2)

Group 1 (PMS Treatment)

ACTIVE COMPARATOR

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.

Other: Group 1 (PMS Treatment)

Group 2 (PCP Treatment)

EXPERIMENTAL

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.

Other: Group 2 (PCP Treatment)

Interventions

Group 2 (PCP Treatment) OTHER

For the PCP group treatment will be performed (pain treatment/medications) by the Primary Care Physician in his/her office/clinic.

Group 2 (PCP Treatment)

Group 1 (PMS Treatment) OTHER

For the PMS group treatment will be performed (pain treatment/medications) by the Pain Medicine Specialist in his/her office/clinic.

Group 1 (PMS Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-structural non-specific chronic low back pain of a least 3 months duration
• years of age or older
• Has a primary care provider (PCP)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Back Pain; Chronic Pain; Pain, Intractable; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Asokumar Buvanendran, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 30, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

US (1)