Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Conditions
Keywords
Veterans, Low Back Pain, Clinical Pathway, Pain Management, Non-Pharmacologic
Brief summary
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. 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 Stepped Care group: * Will continue with regular care * Complete the same surveys at the same time points
Detailed description
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type 1 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 intervention or usual stepped care within the VA health system. In keeping with the pragmatic design, participating VHA sites will receive standardized training and implementation support but will deliver the intervention using their existing clinical staff and resources. Patient-reported outcomes will be collected via telephone-administered Research Electronic Data Capture (REDCap) surveys at baseline and at 2, 4, 6, and 12 months post-randomization. The primary outcome will be assessed at 6 months, with additional follow-up to evaluate longer-term effects 12 months post randomization.
Interventions
OTHERENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped 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 low back pain (LBP) meeting criteria for high-impact chronic pain (HICP), 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.
Sponsors
Duke University
Durham VA Medical Center
Indiana University
University of Arizona
Dallas VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 hospitalization, high risk suicide flag) * Are unable to communicate by telephone or have no telephone access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score | From enrollment to 6 Months | The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater pain interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Ratings of Self-Reported Sleep Quality | Baseline to 6 Months | Sleep quality assessed by the PROMIS 4-item short form: The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater sleep disturbance. |
| Average Ratings of Self-Reported Physical Function | Baseline to 6 Months | Physical function assessed by the PROMIS 4-item short form: The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates better physical function. |
| Average Self-Reported Pain Intensity Ratings | Baseline to 6 Months | Pain intensity assessed by the PROMIS short form: Pain intensity is a standardized, 3-question survey used to quantify how much a patient is hurting. It evaluates three parameters: average pain in the past 7 days, worst pain in the past 7 days, and current pain. Patients receive a raw total score ranging from 3 to 15, where higher scores indicate greater pain severity. |
| Average Self-Reported Endorsement of Depression Symptoms | Baseline to 6 Months | Depression assessed by the PROMIS 4-item short form: The depression form measures self-reported negative mood, feelings of worthlessness, and loss of interest over the past seven days on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates more depression. |
| Average Self-Reported Endorsement of Anxiety Symptoms | Baseline to 6 Months | Anxiety assessed by the PROMIS 4-item short form: The anxiety form measures self-reported anxiety, fear, and hyperarousal over the past seven days on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates more anxiety. |
| Number of Pain-Related Emergency Department (ED) Visits | 12 Months post randomization | Pain-related ED visits by the VA electronic health record (EHR): ED visits for pain measured using International Classification of Diseases coding (ICD) for VA and Non-VA visits. |
| Number of Non-Pharmacologic Pain Care Visits | 6 Months and 12 Months post randomization | Non-pharmacologic pain care visits by the VA EHR: Visits for pain with non-prescribing providers using ICD coding. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hastings, MD
Duke University
Outcome results
None listed