Improving Veteran Access to Integrated Management of Back Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1817 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2025-01-15

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.

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Detailed Description

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Conditions

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Low Back Pain Veterans Family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.

Study Groups

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Integrated Care Pathway

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.

Group Type ACTIVE_COMPARATOR

Pain modulation with physical pain treatment

Intervention Type BEHAVIORAL

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Telephone delivered self-management counseling for increasing physical activity

Intervention Type BEHAVIORAL

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

Telephone delivered behavioral treatment for participants with high risk for continued disability

Intervention Type BEHAVIORAL

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.

Coordinated Care Management Pathway

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.

Group Type ACTIVE_COMPARATOR

Patient preference treatment protocol

Intervention Type BEHAVIORAL

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

Nonpharmacological guideline adherent treatment protocol

Intervention Type BEHAVIORAL

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

Facilitated referrals to existing VA or non-VA pain management resources

Intervention Type BEHAVIORAL

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

Interventions

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Pain modulation with physical pain treatment

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Intervention Type BEHAVIORAL

Telephone delivered self-management counseling for increasing physical activity

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

Intervention Type BEHAVIORAL

Telephone delivered behavioral treatment for participants with high risk for continued disability

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.

Intervention Type BEHAVIORAL

Patient preference treatment protocol

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

Intervention Type BEHAVIORAL

Nonpharmacological guideline adherent treatment protocol

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

Intervention Type BEHAVIORAL

Facilitated referrals to existing VA or non-VA pain management resources

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age \>= 18
2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
3. Provider determines LBP is appropriate for conservative management
4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider

Exclusion Criteria

1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
2. No documented phone number in the electronic health record.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No