Chronic low back pain (CLBP) is a major rehabilitation problem in the VA: it already affects up to 15% of all those in VA primary care, and its high prevalence in discharged combat veterans is likely to add to that care burden. Most back pain patients are not surgical candidates, and medications provide limited analgesia. Symptom control and improved function require a comprehensive approach addressing the cognitive and behavioral aspects of chronic pain. Fortunately, structured, specific rehabilitative treatment, generally conceptualized as Cognitive-Behavioral Self-management Skills Training (CBSST), are available and suitable for implementation in primary care. Over the past 25 years several VA attempts to bridge behavioral health care and primary care have fallen short, perhaps because of three separate but related barriers. These barriers are specialty models;distance;and integration into primary care. The specialty barrier is both that most clinics lack CBSST specialists, and that referral may have low rates of acceptance by primary care patients. A distance barrier is that face-to- face service requires travel-which may be difficult in both urban and rural areas. The VA has now turned to the Medical Home model to overcome specialty barriers and integrate behavioral healthcare into primary care via nurse care managers and patient-aligned care teams. Great progress has been made integrating some aspects of behavioral care (eg, depression, substance abuse) into primary care via nurse care managers, but chronic back pain largely has been neglected. One approach to improving access and integration is "telehealth" outreach. Studies in diverse medical disorders suggest that CBSST can be delivered efficiently and effectively with minimal therapist contact in home-based care models, using telephone consultation to replace clinic visits. In the preceding period of RR&D Merit Review support (2007-2010) this research team adapted a successful VA Pain Clinic cognitive-behavioral therapy program for use in a minimal therapist contact and home- based/telephone-assisted format. In preliminary results from an ongoing randomized clinical trial comparing telephone-administered CBSST to a strong control condition (Supportive Psychotherapy), a significantly higher proportion of CBSST patients reported both overall "improvement" and >25% "improvement" at 8-week end of treatment (all ps <.05). Such results are impressive and an important proof of concept. Nevertheless the 8-week, 12- session format and use of masters psychologists is too specialty-driven, and not truly integrated into primary care. We propose to test the efficacy of a version of our telehealth intervention in an integrated way using primary care nurse managers to overcome both barriers to access and fragmentation of care. The research design is a double blind, randomized, two-arm, parallel groups clinical trial. Patients with CLBP recruited from VA San Diego primary care clinics will receive either the home-based, telephone supported, minimal therapist contact CBSST 8-week intervention (N=70) delivered by medical nurse care managers, or a Supportive Care Control (N=70) condition matched for nurse contact time (8 hours). The primary data analytic strategy will be an intent-to-treat analysis of al participants as randomized, utilizing a linear mixed-model approach. The primary end point will be back-related disability (Oswestry Disability Index). Secondary end points will be pain interference (Brief Pain Inventory), mood (Beck Depression Inventory), general function (Short Form-36), activity (Actigraph(R)), and overall health status (Patient Global Impression of Change). Analyses will test for 8-week end-of-treatment and durability of therapeutic effect at 1, 3, and 6 months post-teatment. Rigorously controlled clinical trials of the type proposed could contribute to more effective, accessible, integrated back pain treatment.

Public Health Relevance

Chronic back pain (pain for >6 months), is a major, treatment-resistant, disabling medical problem for about 15% of veterans in primary care. Gulf War, Iraq, and Afghanistan veterans report back pain rates exceeding 30%, suggesting the VA will continue to face this problem. Cognitive Behavioral Self Management Skills Training (CBSST) improves function in back pain, but is underutilized due to reliance on a referral-based, specialty-clinic model. Using the Medical Home model and its principles of telemedicine, flexible triage, and nurse care managers, we propose to test the efficacy of a telephone- administered, nurse-led, stepped care CBSST for improving back pain outcomes. Rigorously controlled clinical trials of the type proposed could contribute to more accessible, integrated pain treatment.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01RX000542-01A2
Application #
8278477
Study Section
Psychological Health & Social Reintegration (RRD4)
Project Start
2012-07-01
Project End
2015-06-30
Budget Start
2012-07-01
Budget End
2015-06-30
Support Year
1
Fiscal Year
2012
Total Cost
Indirect Cost
Name
VA San Diego Healthcare System
Department
Type
DUNS #
073358855
City
San Diego
State
CA
Country
United States
Zip Code
92161