Improving Veteran Access to Integrated Management of Back Pain

Study Overview
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Brief Summary
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The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

Official Title
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Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial

Conditions
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Low Back Pain, Veterans Family

Intervention / Treatment
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* Behavioral: Pain modulation with physical pain treatment
* Behavioral: Telephone delivered self-management counseling for increasing physical activity
* Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability
* Behavioral: Patient preference treatment protocol
* Behavioral: Nonpharmacological guideline adherent treatment protocol
* Behavioral: Facilitated referrals to existing VA or non-VA pain management resources


Participation Criteria
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Eligibility Criteria
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Clinic eligibility: Volunteer and return signed clinic participation agreement Availability of clinical personnel willing to deliver the treatment interventions (in either arm). Staff and location need to be distinct from other enrolled clinics. Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain. Participant Survey Eligibility Criteria: Inclusion Criteria: Age >= 18 Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic Provider determines LBP is appropriate for conservative management Referred to integrated ICP pathway or CCP pathway by participating clinic provider Exclusion Criteria: Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults) No documented phone number in the electronic health record.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics. We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrated Care Pathway<br>The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA. | Behavioral: Pain modulation with physical pain treatment<br>* Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation<br>Behavioral: Telephone delivered self-management counseling for increasing physical activity<br>* Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient<br>Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability<br>* Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.<br>|
| Active Comparator: Coordinated Care Management Pathway<br>The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain. | Behavioral: Patient preference treatment protocol<br>* the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol<br>Behavioral: Nonpharmacological guideline adherent treatment protocol<br>* the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient<br>Behavioral: Facilitated referrals to existing VA or non-VA pain management resources<br>* the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference Measure | The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. 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. | Baseline, three months post baseline | 
| Change in Physical Function Measure | The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. 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 one representing a better outcome | Baseline, three months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Disturbance | The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome | Baseline, three months post baseline | 
| Change in Patient reported Outcomes--PROMIS Sleep Disturbance | The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome | Baseline, three, six, nine and twelve months | 
| Change in Opioid Use--Chronic User | opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months | Baseline, twelve months post baseline | 
| Change in Opioid Use--Morphine Dose | opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months | Baseline, twelve months post baseline | 
| Change in Patient Reported Outcomes--PROMIS Pain Interference | The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure pain interference. 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 one representing a better outcome | Baseline, three, six, nine and twelve months | 
| Change in Patient Reported Outcomes--PROMIS Physical Function | The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome. | Baseline, three, six, nine and twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical pathway, veterans, low back pain