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

• Published in: Pain medicine (Malden, Mass.) Mass.), 2020-12, Vol.21 (Supplement_2), p.S62-S72
• Main Authors: George, Steven Z, Coffman, Cynthia J, Allen, Kelli D, Lentz, Trevor A, Choate, Ashley, Goode, Adam P, Simon, Corey B, Grubber, Janet M, King, Heather, Cook, Chad E, Keefe, Francis J, Ballengee, Lindsay A, Naylor, Jennifer, Brothers, Joseph Leo, Stanwyck, Catherine, Alkon, Aviel, Hastings, Susan N
• Format: Article
• Language: English
• Subjects: Back pain; EDITORIALS; Electronic medical records; Health care; Humans; Low back pain; Low Back Pain - therapy; Opioids; Pain Management; Randomized Controlled Trials as Topic; Surveys and Questionnaires; Time Factors; Veterans
• ISSN: 1526-2375; 1526-4637
• DOI: 10.1093/pm/pnaa348

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.