Improving Veteran Access to Integrated Management of Chronic Back Pain LBP is among the most prevalent and disabling medical problems for Veterans. Improving patient care for LBP is a high priority for many federal agencies and recent clinical practice guidelines emphasize the importance of non-pharmacological management of LBP. However, optimal care pathways involving non-pharmacological treatments have not been established. Care pathways aligned with a ?biopsychosocial? conceptualization of LBP are highly valued, but are rarely delivered in routine practice environments and still need to be investigated for their effectiveness. The overall goal of this UG3 (Planning Phase)/UH3 (Demonstration Project) proposal is to improve access to recommended non-pharmacologic therapies for LBP in the Department of VA Health Care System. In UG3 phase trial planning will be accomplished through two aims: 1) establish policies, procedures, and regulatory agreements for data management and resource sharing needs and 2) finalize research design and clinical protocols needed to conduct a high-quality, multi-center pragmatic cluster randomized trial. The pragmatic cluster randomized trial proposed for the UH3 Demonstration Project will compare the effectiveness of two LBP management approaches designed to enhance access to non- pharmacological pain treatments and biopsychosocial oriented care: a) sequenced, multi-modal integrated care pathway incorporating physical pain treatment, tailored behavioral treatment, and home base activity versus 2) care management by pain navigator program that facilitates coordinated use of existing VA or non- VA pain management resources. With clinical practice guidelines in mind, both pathways have been purposefully structured to include non-pharmacological pain modulation. Veterans enrolled in the trial (n = 1,250) will be followed for primary outcomes (PROMIS Short Form scores for pain interference and function) captured from the electronic health record and a subset (n = 630) will complete phone captured patient reported secondary augment electronic health record capture.
In Aim 1 we will examine the effectiveness of a sequenced, multi-modal integrated care pathway for LBP, compared to a care management by pain navigator program. Our central hypothesis is that the multi-modal, integrated care pathway will reduce pain interference with normal activities and improve physical function compared with the care management program.
In Aim 2 we will determine participant characteristics associated with greater improvements in pain interference and function, and better adherence to each care pathway.
Aim 2 will inform the potential for matching Veteran subgroup characteristics to a specific care pathway that provides greater potential for improvement in pain and function. This proposal is directly aligned with primary goals of the NIH-DoD-VA Pain Management Collaboratory by aligning existing VA health system resources to expand capacity to deliver earlier non- pharmacological pain management for the Veteran with LBP.

Public Health Relevance

Low back pain is a prevalent and disabling problem for Veterans that often involves pharmacological or surgical approaches that carry higher than desired risks. Non-pharmacological pain management has a lower risk profile and can be effective for pain relief, but best practices for treatment delivery to Veterans is largely unknown. This project will plan and implement a pragmatic clinical trial to examine the effectiveness of a multi- modal, integrated care pathway for low back pain, compared to a care management via pain navigator program that coordinates access to pain management services. There is high public health relevance for this proposal because it provides infrastructure to enhance pain research capacity within the Veterans Administration health care system, and directly informs on the comparative effectiveness of different pain management approaches that increase exposure to non-pharmaceutical treatments.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Cooperative Agreement Phase II (UH3)
Project #
5UH3AT009790-04
Application #
10129286
Study Section
Special Emphasis Panel (NSS)
Program Officer
Weber, Wendy J
Project Start
2017-09-20
Project End
2024-02-29
Budget Start
2021-03-01
Budget End
2022-02-28
Support Year
4
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Duke University
Department
Orthopedics
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705