Improving Veteran Access to Integrated Management of Back Pain (AIM-BACK)

March 15, 2024 updated by: Duke University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1815

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
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.
Active Comparator: 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.
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Interference Measure
Time Frame: 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.
Baseline, three months post baseline
Change in Physical Function Measure
Time Frame: 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.
Baseline, three months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Disturbance
Time Frame: 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
Baseline, three months post baseline
Change in Opioid Use--Chronic User
Time Frame: 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
Baseline, twelve months post baseline
Change in Opioid Use--Morphine Dose
Time Frame: 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
Baseline, twelve months post baseline
Change in Patient reported Outcomes--PROMIS Sleep Disturbance
Time Frame: 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
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--PROMIS Pain Interference
Time Frame: 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
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--PROMIS Physical Function
Time Frame: 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.
Baseline, three, six, and twelve months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Reported Outcomes--Catastrophizing
Time Frame: Baseline, three, six, and twelve months
Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
Time Frame: Baseline, three, six, and twelve months
The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate a series of alcohol use questions on a scale of 0-4 with zero representing a better outcome
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool
Time Frame: Baseline, three, six, and twelve months
The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
Time Frame: Baseline, three, six, and twelve months
Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--Depressed Mood
Time Frame: Baseline, three, six, and twelve months
The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week.
Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--Quality of Life
Time Frame: Baseline, three, six, and twelve months
The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EUROQUOL asks the participant a series of questions related to quality of life on a scale of 0-5.
Baseline, three, six, and twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Susan N Hastings, MD, Duke University / Durham VA
  • Principal Investigator: Steven Z George, PT, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00101938
  • UH3AT009790 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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