Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
Duke University
Summary
The goal of this clinical trial is to help Veterans manage high-impact chronic low back pain. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which Veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems. What Will Happen: Veterans in this clinical trial will be randomly placed into one of two groups. ENCompaSS group (intervention): * Have at least three phone calls with a trained clinician over about 12 weeks * Watch short online videos about managing pain * Complete surveys before the study and again at 2, 4, 6, and 12 months Usual care group: * Will continue with regular care * Complete the same surveys at the same time points
Description
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type I hybrid effectiveness-implementation trial conducted within three Veterans Heath Administration (VHA) systems. The intervention is a patient-centered, navigator-assisted program designed to inform and guide Veterans on non-pharmacologic treatment options. The total study duration, including enrollment and follow-up, is approximately 30 months. A total of 530 Veterans with high-impact chronic pain (HICP) due to low back pain (LBP) will be enrolled and randomized in a 1:1 ratio to receive either the ENCompaSS inter…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Be age 18 years old or older * Have a VA outpatient clinic visit for low back pain within the previous 30 days * Be enrolled in a participating primary care clinic * Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items) * Valid telephone access * Ability to provide informed consent Exclusion Criteria: * Are currently hospitalized or residing in a nursing home * Have cognitive impairment or lack of decision-making capacity * Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitaliz…
Interventions
- OtherENCompaSS (Education, Navigated Care, and Supported Self-Management) pain care program with usual care
The ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for a chronic condition (high impact LBP) intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM. ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes.
Location
- Durham VADurham, North Carolina