Improving Veteran Access to Integrated Management of Back Pain

NCT04411420 | Completed Results DMC

• 2 other identifiers: Pro00101938UH3AT009790
• Study Type: interventional
• Target: 1,817
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Veterans Family

Keywords

clinical pathway; veterans; low back pain

Outcome Measures

Primary Outcomes (2)

• 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. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.

  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 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.

  Baseline, three months post baseline

Secondary Outcomes (6)

• Change in Sleep Disturbance

  Baseline, three months post baseline

• Change in Patient Reported Outcomes--PROMIS Sleep Disturbance

  Baseline, three, six, and twelve months

• Number of Participants With Opioid Use--Chronic User

  Baseline, twelve months post baseline

• Change in Opioid Use - Morphine Dose

  Baseline, twelve months post baseline

• Change in Patient Reported Outcomes--PROMIS Pain Interference

  Baseline, three, six, and twelve months

Other Outcomes (6)

• Change in Patient Reported Outcomes--Catastrophizing

  Baseline, three, six, and twelve months

• Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)

  Baseline, three, six, and twelve months

• Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool

  Baseline, three, six, and twelve months

Study Arms (2)

Integrated Care Pathway

ACTIVE COMPARATOR

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; Behavioral: Telephone delivered self-management counseling for increasing physical activity; Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability

Coordinated Care Management Pathway

ACTIVE COMPARATOR

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; Behavioral: Nonpharmacological guideline adherent treatment protocol; Behavioral: Facilitated referrals to existing VA or non-VA pain management resources

Interventions

Pain modulation with physical pain treatment BEHAVIORAL

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

Integrated Care Pathway

Telephone delivered self-management counseling for increasing physical activity BEHAVIORAL

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

Integrated Care Pathway

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

Integrated Care Pathway

Patient preference treatment protocol BEHAVIORAL

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

Coordinated Care Management Pathway

Nonpharmacological guideline adherent treatment protocol BEHAVIORAL

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

Coordinated Care Management Pathway

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

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

Coordinated Care Management Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Durham VA Medical Center: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Durham VA

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.

  PMID: 33313728 BACKGROUND

• Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.

  PMID: 37756618 BACKGROUND

• Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.

  PMID: 37269070 BACKGROUND

• George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24317833. doi: 10.1101/2024.11.23.24317833.

  PMID: 39649618 DERIVED

Related Links

• Updated Statistical Analysis Plan Preprint

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leo Brothers
• Organization: Duke University

joseph.l.brothers@duke.edu

919-668-8322

Study Officials

• Susan N Hastings, MD

  Duke University / Durham VA

  PRINCIPAL INVESTIGATOR

• Steven Z George, PT, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: March 8, 2021
• Primary Completion: May 13, 2024
• Study Completion: January 15, 2025
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data and other resources referenced will be available one year after the date of publication for the primary analyses, which is in alignment with the VA Office of Research and Development.
• Access Criteria: We plan on using a de-identified dataset is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case by case basis. Requirements include: * data will be used for research purposes and not to identify subjects * data must be secured using appropriate computer technology * data must be destroyed or returned after any analysis are complete * authors of any manuscript resulting from this data must acknowledge the source of the data * analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap * coauthors must be given a chance for review and approval of a draft manuscript prior to submission

Locations

US (1)