<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04411420</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101938</org_study_id>
    <secondary_id>UH3AT009790</secondary_id>
    <nct_id>NCT04411420</nct_id>
  </id_info>
  <brief_title>Improving Veteran Access to Integrated Management of Back Pain</brief_title>
  <acronym>AIM-BACK</acronym>
  <official_title>Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Durham VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose and objective of this pragmatic trial is to examine the effectiveness of two&#xD;
      different quality improvement care pathways for low back pain (LBP); a sequenced, integrated&#xD;
      care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the&#xD;
      central hypothesis that the ICP will reduce pain interference with normal activities and&#xD;
      improve physical function, as measured by Patient Reported Outcomes Measurement Information&#xD;
      System (PROMIS) Short Form scores when compared to the CCP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2021</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.&#xD;
We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Interference Measure</measure>
    <time_frame>Baseline, three months post baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical Function Measure</measure>
    <time_frame>Baseline, three months post baseline</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Disturbance</measure>
    <time_frame>Baseline, three months post baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient reported Outcomes--PROMIS Sleep Disturbance</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Opioid Use--Chronic User</measure>
    <time_frame>Baseline, twelve months post baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Opioid Use--Morphine Dose</measure>
    <time_frame>Baseline, twelve months post baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcomes--PROMIS Pain Interference</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcomes--PROMIS Physical Function</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Catastrophizing</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, nine 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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>The PEG screening tool scores will be collected by the interviewers at baseline, three, six, nine 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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Depressed Mood</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, nine 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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient Reported Outcomes--Quality of Life</measure>
    <time_frame>Baseline, three, six, nine and twelve months</time_frame>
    <description>The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, nine 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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1680</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Veterans Family</condition>
  <arm_group>
    <arm_group_label>Integrated Care Pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coordinated Care Management Pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain modulation with physical pain treatment</intervention_name>
    <description>Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation</description>
    <arm_group_label>Integrated Care Pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone delivered self-management counseling for increasing physical activity</intervention_name>
    <description>Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient</description>
    <arm_group_label>Integrated Care Pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone delivered behavioral treatment for participants with high risk for continued disability</intervention_name>
    <description>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.</description>
    <arm_group_label>Integrated Care Pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient preference treatment protocol</intervention_name>
    <description>the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol</description>
    <arm_group_label>Coordinated Care Management Pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nonpharmacological guideline adherent treatment protocol</intervention_name>
    <description>the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient</description>
    <arm_group_label>Coordinated Care Management Pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facilitated referrals to existing VA or non-VA pain management resources</intervention_name>
    <description>the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.</description>
    <arm_group_label>Coordinated Care Management Pathway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinic eligibility:&#xD;
&#xD;
          -  Volunteer and return signed clinic participation agreement&#xD;
&#xD;
          -  Availability of clinical personnel willing to deliver the treatment interventions (in&#xD;
             either arm).&#xD;
&#xD;
          -  Staff and location need to be distinct from other enrolled clinics.&#xD;
&#xD;
          -  Clinics can have a variable number of providers, but together meet criteria for range&#xD;
             of monthly visits for low back pain.&#xD;
&#xD;
        Participant Survey Eligibility Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;= 18&#xD;
&#xD;
          2. Seeking care for LBP with or without radiating symptoms from a participating VA&#xD;
             primary care clinic&#xD;
&#xD;
          3. Provider determines LBP is appropriate for conservative management&#xD;
&#xD;
          4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receiving or referred for hospice/ palliative care (defined by encounter codes and&#xD;
             CPRS consults)&#xD;
&#xD;
          2. No documented phone number in the electronic health record.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan N Hastings, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University / Durham VA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Z George, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leo Brothers, MPH</last_name>
    <phone>919-668-8322</phone>
    <email>joseph.l.brothers@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catherine Stanwyck</last_name>
    <email>catherine.stanwyck@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Durham VA</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clinical pathway</keyword>
  <keyword>veterans</keyword>
  <keyword>low back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_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_time_frame>
    <ipd_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:&#xD;
data will be used for research purposes and not to identify subjects&#xD;
data must be secured using appropriate computer technology&#xD;
data must be destroyed or returned after any analysis are complete&#xD;
authors of any manuscript resulting from this data must acknowledge the source of the data&#xD;
analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap&#xD;
coauthors must be given a chance for review and approval of a draft manuscript prior to submission</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT04411420/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04411420
org study id: Pro00101938
secondary id: UH3AT009790
nct id: NCT04411420
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: 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.
measure: Change in Pain Interference Measure
time frame: Baseline, three months post baseline
description: 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.
measure: Change in Physical Function Measure
time frame: Baseline, three months post baseline
description: 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
measure: Change in Sleep Disturbance
time frame: Baseline, three months post baseline
description: 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
measure: Change in Patient reported Outcomes--PROMIS Sleep Disturbance
time frame: Baseline, three, six, nine and twelve months
description: 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
measure: Change in Opioid Use--Chronic User
time frame: Baseline, twelve months post baseline
description: 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
measure: Change in Opioid Use--Morphine Dose
time frame: Baseline, twelve months post baseline
description: 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
measure: Change in Patient Reported Outcomes--PROMIS Pain Interference
time frame: Baseline, three, six, nine and twelve months
description: 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
measure: Change in Patient Reported Outcomes--PROMIS Physical Function
time frame: Baseline, three, six, nine and twelve months
description: 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.
measure: Change in Patient Reported Outcomes--Catastrophizing
time frame: Baseline, three, six, nine and twelve months
description: Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.
measure: Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
time frame: Baseline, three, six, nine and twelve months
description: The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, nine 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
measure: Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool
time frame: Baseline, three, six, nine and twelve months
description: The PEG screening tool scores will be collected by the interviewers at baseline, three, six, nine 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
measure: Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
time frame: Baseline, three, six, nine and twelve months
description: Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.
measure: Change in Patient Reported Outcomes--Depressed Mood
time frame: Baseline, three, six, nine and twelve months
description: The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, nine 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.
measure: Change in Patient Reported Outcomes--Quality of Life
time frame: Baseline, three, six, nine and twelve months
description: The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, nine 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.
arm group label: Integrated Care Pathway
arm group type: Active Comparator
description: 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.
arm group label: Coordinated Care Management Pathway
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Pain modulation with physical pain treatment
description: Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
arm group label: Integrated Care Pathway
intervention type: Behavioral
intervention name: Telephone delivered self-management counseling for increasing physical activity
description: Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
arm group label: Integrated Care Pathway
intervention type: Behavioral
intervention name: Telephone delivered behavioral treatment for participants with high risk for continued disability
description: 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.
arm group label: Integrated Care Pathway
intervention type: Behavioral
intervention name: Patient preference treatment protocol
description: the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
arm group label: Coordinated Care Management Pathway
intervention type: Behavioral
intervention name: Nonpharmacological guideline adherent treatment protocol
description: the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
arm group label: Coordinated Care Management Pathway
intervention type: Behavioral
intervention name: Facilitated referrals to existing VA or non-VA pain management resources
description: the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
arm group label: Coordinated Care Management Pathway
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan N Hastings, MD
role: Principal Investigator
affiliation: Duke University / Durham VA
last name: Steven Z George, PT, PhD
role: Principal Investigator
affiliation: Duke University
last name: Leo Brothers, MPH
phone: 919-668-8322
email: joseph.l.brothers@duke.edu
last name: Catherine Stanwyck
email: catherine.stanwyck@va.gov
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd 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 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
provided document: 