Integrated vs. Coordinated Pain Management for Back Pain

(AIM-BACK Trial)

Overseen By Leo Brothers, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hospice, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

1815 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steven Z George, PT, PhD

Principal Investigator

Duke University

Susan N Hastings, MD

Principal Investigator

Duke University / Durham VA

Eligibility Criteria

This trial is for veterans aged 18 or older seeking conservative management for low back pain at participating VA clinics. They must not be in hospice/palliative care and need to have a documented phone number. Clinics should have distinct staff and locations from other enrolled clinics.

Inclusion Criteria

My healthcare team is ready to provide the required treatment.

My healthcare team is available to provide the required treatment.

My doctor thinks my lower back pain can be managed without surgery.

Exclusion Criteria

No documented phone number in the electronic health record

I am currently receiving or have been referred for end-of-life care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the Integrated Care Pathway (ICP) or the Coordinated Care Management Pathway (CCP) for low back pain management

12 months

Regular visits as per care pathway protocol

Follow-up

Participants are monitored for changes in physical function, pain interference, and other outcomes using PROMIS and other questionnaires

12 months

Follow-up assessments at 3, 6, and 12 months

Treatment Details

Interventions

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

Trial Overview The trial tests two quality improvement pathways for managing low back pain: an Integrated Care Pathway (ICP) with sequenced treatments, and a Coordinated Care Management Pathway (CCP). It aims to see which pathway better reduces pain interference with activities and improves physical function.

Participant Groups

Group I: Coordinated Care Management Pathway Active Control 3 Interventions

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.

Group II: Integrated Care Pathway Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Durham VA Medical Center

Collaborator

Trials

40

Recruited

9,300+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+