<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/NCT04490291</url>
  </required_header>
  <id_info>
    <org_study_id>RD04240531</org_study_id>
    <nct_id>NCT04490291</nct_id>
  </id_info>
  <brief_title>An Observational Study of Integrated Chronic Pain Management in a Community Health Center</brief_title>
  <official_title>An Observational Study of Integrated Chronic Pain Management in a Community Health Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Logan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      This was a prospective observational study with the primary objective of quantifying a change&#xD;
      in pain scores after 6-12 months of two separate interventions within the study site (pain&#xD;
      team and chiropractic team). Target enrollment was 30 participants for each intervention. The&#xD;
      primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the&#xD;
      study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily&#xD;
      dose, and its effect on PDQ scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data collection After participants were enrolled, they completed a baseline PDQ while waiting&#xD;
      for their appointment. Participants continued to see the intervention group, PCP, and other&#xD;
      medical providers as determined by their health providers independent of this study's&#xD;
      protocol. Another PDQ was collected at an intended 6 - 12 months later. Demographic&#xD;
      information was collected by manual chart review in the electronic medical record NextGen&#xD;
      (NextGen EHR, Nextgen Healthcare, Inc. Irvine, CA, USA).&#xD;
&#xD;
      Variables collected included age, sex, race, BMI, insurance type, preferred language,&#xD;
      presence of another pain diagnosis (e.g. knee pain), active mental health diagnosis&#xD;
      (including substance abuse), diagnosis of hypertension or diabetes, and morphine equivalent&#xD;
      dose (MED); one post-hoc variable was recorded: timing of follow-up survey in relation to the&#xD;
      2019 coronavirus (COVID-19) pandemic, defined as before/after March 1, 2020. Intervention&#xD;
      type was analyzed as an independent variable since the study was not designed as a comparison&#xD;
      of interventions. All data was stored in an encrypted Excel database on a password-protected&#xD;
      laptop. Consent forms were stored in a locked cabinet accessible only to the PI.&#xD;
&#xD;
      Stata 16.0 (StataCorp, LLC, College Station, TX, USA) was used for statistical analysis. PDQ&#xD;
      scores at baseline and follow-up were tested for statistical significance using paired&#xD;
      t-tests. Univariate analysis was performed on individual categorical variables and change in&#xD;
      PDQ using two-sample t-tests. Multivariate linear regression was used to determine&#xD;
      associations of these factors to the outcome. Variables were excluded from regression models&#xD;
      if there was a subgroup size of six or less.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>change in Pain Disability Questionnaire (PDQ) score</measure>
    <time_frame>6-12 month</time_frame>
    <description>6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prescription opioid weaning</measure>
    <time_frame>6-12 months</time_frame>
    <description>ability to successfully wean off opioid prescription</description>
  </secondary_outcome>
  <enrollment type="Actual">42</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Spine Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>chronic pain team</intervention_name>
    <description>enrollment in chronic pain team at study site</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>chiropractic team</intervention_name>
    <description>enrollment in chiropractic team/intervention at study site</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        active patients at an urban federally-qualified health center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referred by PCP to either intervention at study site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active cancer diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Affinia Healthcare</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Chrisotpher Prater</investigator_full_name>
    <investigator_title>Assistant Professor in Medicine and Pediatrics</investigator_title>
  </responsible_party>
  <keyword>community health center</keyword>
  <keyword>integrated pain team</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>methodology and data will be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>after publication, available indefinitely</ipd_time_frame>
    <ipd_access_criteria>by request</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>July 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT04490291/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/NCT04490291
org study id: RD04240531
nct id: NCT04490291
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This was a prospective observational study with the primary objective of quantifying a change
      in pain scores after 6-12 months of two separate interventions within the study site (pain
      team and chiropractic team). Target enrollment was 30 participants for each intervention. The
      primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the
      study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily
      dose, and its effect on PDQ scores.
Data collection After participants were enrolled, they completed a baseline PDQ while waiting
      for their appointment. Participants continued to see the intervention group, PCP, and other
      medical providers as determined by their health providers independent of this study's
      protocol. Another PDQ was collected at an intended 6 - 12 months later. Demographic
      information was collected by manual chart review in the electronic medical record NextGen
      (NextGen EHR, Nextgen Healthcare, Inc. Irvine, CA, USA).

      Variables collected included age, sex, race, BMI, insurance type, preferred language,
      presence of another pain diagnosis (e.g. knee pain), active mental health diagnosis
      (including substance abuse), diagnosis of hypertension or diabetes, and morphine equivalent
      dose (MED); one post-hoc variable was recorded: timing of follow-up survey in relation to the
      2019 coronavirus (COVID-19) pandemic, defined as before/after March 1, 2020. Intervention
      type was analyzed as an independent variable since the study was not designed as a comparison
      of interventions. All data was stored in an encrypted Excel database on a password-protected
      laptop. Consent forms were stored in a locked cabinet accessible only to the PI.

      Stata 16.0 (StataCorp, LLC, College Station, TX, USA) was used for statistical analysis. PDQ
      scores at baseline and follow-up were tested for statistical significance using paired
      t-tests. Univariate analysis was performed on individual categorical variables and change in
      PDQ using two-sample t-tests. Multivariate linear regression was used to determine
      associations of these factors to the outcome. Variables were excluded from regression models
      if there was a subgroup size of six or less.
observational model: Cohort
time perspective: Prospective
measure: change in Pain Disability Questionnaire (PDQ) score
time frame: 6-12 month
description: 6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)
measure: prescription opioid weaning
time frame: 6-12 months
description: ability to successfully wean off opioid prescription
intervention type: Other
intervention name: chronic pain team
description: enrollment in chronic pain team at study site
intervention type: Other
intervention name: chiropractic team
description: enrollment in chiropractic team/intervention at study site
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Chrisotpher Prater
investigator title: Assistant Professor in Medicine and Pediatrics
mesh term: Spinal Diseases
mesh term: Chronic Pain
sharing ipd: Yes
ipd description: methodology and data will be available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: after publication, available indefinitely
ipd access criteria: by request
provided document: 