Improving Veteran Access to Integrated Management of Back Pain (AIM-BACK)

Duke University

Status: Completed

Conditions: Veterans Family; Low Back Pain

Treatments: Behavioral: Nonpharmacological guideline adherent treatment protocol; Behavioral: Patient preference treatment protocol; Behavioral: Pain modulation with physical pain treatment; Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability; Behavioral: Facilitated referrals to existing VA or non-VA pain management resources; Behavioral: Telephone delivered self-management counseling for increasing physical activity

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04411420

UH3AT009790 (U.S. NIH Grant/Contract)

Pro00101938

Details and patient eligibility

About

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

Enrollment: 1,817 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinic eligibility:

• Volunteer and return signed clinic participation agreement
• Availability of clinical personnel willing to deliver the treatment interventions (in either arm).
• Staff and location need to be distinct from other enrolled clinics.
• Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.

Participant Survey Eligibility Criteria:

Inclusion Criteria:

1. Age >= 18
2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
3. Provider determines LBP is appropriate for conservative management
4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider

Exclusion Criteria:

1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
2. No documented phone number in the electronic health record.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,817 participants in 2 patient groups

Integrated Care Pathway

Active Comparator group

Description:

The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.

Treatment:

Behavioral: Telephone delivered self-management counseling for increasing physical activity

Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability

Behavioral: Pain modulation with physical pain treatment

Coordinated Care Management Pathway

Active Comparator group

Description:

The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.

Treatment:

Behavioral: Facilitated referrals to existing VA or non-VA pain management resources

Behavioral: Patient preference treatment protocol

Behavioral: Nonpharmacological guideline adherent treatment protocol