Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial

Steven Z George, Cynthia J Coffman, Kelli D Allen, Trevor A Lentz, Ashley Choate, Adam P Goode, Corey B Simon, Janet M Grubber, Heather King, Chad E Cook, Francis J Keefe, Lindsay A Ballengee, Jennifer Naylor, Joseph Leo Brothers, Catherine Stanwyck, Aviel Alkon, Susan N Hastings, Steven Z George, Cynthia J Coffman, Kelli D Allen, Trevor A Lentz, Ashley Choate, Adam P Goode, Corey B Simon, Janet M Grubber, Heather King, Chad E Cook, Francis J Keefe, Lindsay A Ballengee, Jennifer Naylor, Joseph Leo Brothers, Catherine Stanwyck, Aviel Alkon, Susan N Hastings

Abstract

Background: Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown.

Design: The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures.

Summary: AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

Keywords: Care Pathways; Nonpharmacologic; Pain Interference; Pain Management; Physical Function.

© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Figures

Figure 1.
Figure 1.
Overview of Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial design.
Figure 2.
Figure 2.
Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) for Improving Veteran Access to Integrated Management of Back Pain (AIM-Back). Adapted by permission from BMJ Publishing Group Limited. [The PRECIS-2 tool: designing trials that are fit for purpose, Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. BMJ 2015;350:h2147]
Figure 3.
Figure 3.
Overview of the integrated sequenced-care pathway for low back pain. 1. Participants are referred from a physician to central delivery to explain the Integrated Sequenced Care Pathway; initiate on-site physical therapy services; and receive an examination, on-site treatment, and a transcutaneous electrical nerve stimulation (TENS) unit. 2. Participants are referred for approximately 6 weeks of centrally delivered physical activity instruction. 3. Participants follow up with Department of Veterans Affairs (VA) physical therapy services for reexamination. 4. Participants complete the STarT Back Screening Tool (SBST). Patients who are considered “low risk” are discharged to home with instructions to continue their physical activity program. Patients who are considered “medium to high risk” are referred for approximately 6 weeks of a centrally delivered, psychologically informed intervention. 5. Participants who receive psychologically informed interventions are discharged to home upon completion.
Figure 4.
Figure 4.
Coordinated pain navigator pathway for low back pain. 1. Participants are referred from their physician to a clinic pain navigator. The pain navigator contacts patients via telephone or video conference. The pain navigator and patient engage in a shared decision-making process to identify the appropriate Department of Veterans Affairs (VA) service for the patient’s low back pain. • Pain navigator provides information on current VA-recommended guidelines for nonpharmacologic and nonsurgical pain management as well as availability of services. • Patient provides their service preferences. 2. Pain navigator coordinates consultation input with physician. Participant attends service. 3. At the completion of service, participants either do not seek further care and are discharged to home or seek further care through the pain navigator. 4. Participants who seek further care through the pain navigator reengage in the shared decision-making process to identify the next appropriate VA service. The pain navigator coordinates consultation input with the physician, and the participant attends a second service. 5. At the completion of service, participants either do not seek further care and are discharged to home or seek further care. Those seeking further care follow up with the pain navigator, who coordinates referral back to the physician.

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