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

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.

Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial

“…In the AIM-Back PCT, the phased design allowed for early partner engagement that enhanced development of multimodal non-pharmacological treatment pathways. 20 Key changes included expansion of provider types and re-framing of the interventions intended to improve patient experience and enhance patient participation. Other main changes such as the inclusion of a primary care feedback loop and established discharge criteria focused on reducing interference of clinical workflow and increasing provider engagement and buy-in.…”

Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Updated Statistical Analysis Plan for this Embedded Pragmatic, Cluster Randomized

“…Additionally, we present updated models for our sensitivity and missing data analyses. This updated analysis plan, along with the previously published protocol paper[1], are key source documents for evaluating the primary results of care pathway effectiveness from the AIM-Back trial.…”

“…We have collected the primary PROMIS outcomes for pain interference and physical function in the EHR. As described in our protocol paper [1], Veterans that are referred to the AIM-Back program by providers can also agree to be contacted for a survey study. These Veterans provide consent to participate, and are administered surveys that include the primary PROMIS measure outcomes and additional measures at baseline 3, 6, and 12 months follow-up.…”

“…The Improving Veteran Access to Integrated Management of Back Pain (AIM -Back) pragmatic, embedded, cluster-randomized trial is ongoing with key elements of the study design, care pathways, primary outcomes and data analysis included in the published protocol paper. [1] AIM-Back was prospectively registered at www.clinicaltrials.gov (NCT04411420), began enrollment in February 2020, and is expected to continue enrollment into the first quarter of 2024. In response to a recommendation from our Data Safety Monitoring Board and in collaboration with study sponsor (National Center for Complementary and Integrative Health) and the NIH/DoD/VA Pain Management Collaboratory Biostatistics and Study Design Work Group we are updating our analysis plan prior to completing enrollment.…”

Ethical challenges of prospective clinical trials during the COVID-19 pandemic

“…In order to create a generation of researchers capable of conducting these trials, we must change the way biomedical research is conducted [ 61 , 62 ]. In most cases, there is a firewall between full-time clinicians and full-time researchers.…”