Improving Veteran Access to Integrated Management of Back Pain

Not Applicable

Active, not recruiting

• Conditions: Veterans Family; Low Back Pain
• Interventions: Behavioral: Patient preference treatment protocol; Behavioral: Pain modulation with physical pain treatment; Behavioral: Nonpharmacological guideline adherent treatment protocol; Behavioral: Telephone delivered self-management counseling for increasing physical activity; Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability; Behavioral: Facilitated referrals to existing VA or non-VA pain management resources

• Registration Number: NCT04411420
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Study Start: 2021-03-08
• Status Verified: 2024-03
• Primary Completion: 2024-05-13
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1815

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coordinated Care Management Pathway	Patient preference treatment protocol	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.
Coordinated Care Management Pathway	Nonpharmacological guideline adherent treatment protocol	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.
Integrated Care Pathway	Telephone delivered behavioral treatment for participants with high risk for continued disability	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.
Integrated Care Pathway	Pain modulation with physical pain treatment	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.
Integrated Care Pathway	Telephone delivered self-management counseling for increasing physical activity	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.
Coordinated Care Management Pathway	Facilitated referrals to existing VA or non-VA pain management resources	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Interference Measure	Baseline, three months post baseline	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. With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.
Change in Physical Function Measure	Baseline, three months post baseline	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. With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.

Secondary Outcome Measures

Name	Time	Method
Change in Patient reported Outcomes--PROMIS Sleep Disturbance	Baseline, three, six, and twelve months	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, 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
Change in Opioid Use--Chronic User	Baseline, twelve months post baseline	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
Change in Opioid Use--Morphine Dose	Baseline, twelve months post baseline	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
Change in Patient Reported Outcomes--PROMIS Physical Function	Baseline, three, six, and twelve months	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, 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.
Change in Sleep Disturbance	Baseline, three months post baseline	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
Change in Patient Reported Outcomes--PROMIS Pain Interference	Baseline, three, six, and twelve months	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, 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

Trial Locations

Locations (1)

Durham VA; 🇺🇸 Durham, North Carolina, United States