<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/NCT02190240</url>
  </required_header>
  <id_info>
    <org_study_id>AT006518-01</org_study_id>
    <secondary_id>R01AT006518-01</secondary_id>
    <nct_id>NCT02190240</nct_id>
  </id_info>
  <brief_title>Effect of Complementary and Alternative Medicine on Pain Among Inpatients</brief_title>
  <official_title>Effect of Complementary and Alternative Medicine on Pain Among Inpatients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Allina Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study has 3 aims: 1) quantitatively describe a model for delivering&#xD;
      complementary and alternative medicine (CAM) therapies to understand the selection of&#xD;
      patients and CAM therapies used for pain management, 2) examine the effects of selected CAM&#xD;
      therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies&#xD;
      on duration of pain change.&#xD;
&#xD;
      Positive results from this study will assist hospitals in the integration of usual care and&#xD;
      CAM therapy for pain reduction. Findings may also drive future research on the cost&#xD;
      effectiveness of these therapies for pain management, as well as the impact on patient&#xD;
      outcomes such as length of stay and use of narcotics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Model of delivering CAM therapies</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Quantitatively describe a model for delivering CAM therapies to understand selection of patients and CAM therapies used for pain management.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of selected CAM therapies on immediate change in pain</measure>
    <time_frame>CAM Visit (30-45 minutes)</time_frame>
    <description>We will examine the effectiveness of CAM therapies on self-reported (11 point scale) pain measured just before and immediately after service delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of selected CAM therapies on duration of pain change.</measure>
    <time_frame>5 hours</time_frame>
    <description>We will examine the effectiveness of CAM therapies on repeated measures of self-reported pain over several hours after therapy to assess the distribution and decay of the pain change effect.</description>
  </primary_outcome>
  <enrollment type="Actual">4422</enrollment>
  <condition>Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Abbott Northwestern Hospital Inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Aims 1 and 2 Inclusion Criteria:&#xD;
&#xD;
          -  Admission to Abbott Northwestern Hospital&#xD;
&#xD;
          -  Consent to release of electronic health record for research purposes&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Length of stay greater than 24 hours&#xD;
&#xD;
        Aims 1 and 2 Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
        Aim 3 Inclusion Criteria:&#xD;
&#xD;
          -  Admission to Abbott Northwestern Hospital&#xD;
&#xD;
          -  Length of stay greater than 24 hours&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Consent to release of electronic health record for research purposes&#xD;
&#xD;
          -  Received CAM therapy in current hospitalization&#xD;
&#xD;
          -  Pain level of 1 or greater at the pre-treatment assessment by practitioner&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Integrative medicine therapy ended between 9:00 am and 4:00 pm&#xD;
&#xD;
        Aim 3 Exclusion Criteria:&#xD;
&#xD;
          -  Refuses consent&#xD;
&#xD;
          -  Unable to provide consent due to competency concerns&#xD;
&#xD;
          -  Has declined study participation 3 times during current hospitalization&#xD;
&#xD;
          -  Has hard declined during current hospitalization&#xD;
&#xD;
          -  Has been approached 6 times during current hospitalization&#xD;
&#xD;
          -  Has been approached to consent earlier that day&#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>Jeffery Dusek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Complementary and Alternative Medicine</keyword>
  <keyword>Integrative Medicine</keyword>
  <keyword>Pain Management</keyword>
  <!-- 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/NCT02190240
org study id: AT006518-01
secondary id: R01AT006518-01
nct id: NCT02190240
lead sponsor: 
collaborator: 
has dmc: Yes
The proposed study has 3 aims: 1) quantitatively describe a model for delivering
      complementary and alternative medicine (CAM) therapies to understand the selection of
      patients and CAM therapies used for pain management, 2) examine the effects of selected CAM
      therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies
      on duration of pain change.

      Positive results from this study will assist hospitals in the integration of usual care and
      CAM therapy for pain reduction. Findings may also drive future research on the cost
      effectiveness of these therapies for pain management, as well as the impact on patient
      outcomes such as length of stay and use of narcotics.
observational model: Case-Only
measure: Model of delivering CAM therapies
time frame: Up to 4 years
description: Quantitatively describe a model for delivering CAM therapies to understand selection of patients and CAM therapies used for pain management.
measure: Effects of selected CAM therapies on immediate change in pain
time frame: CAM Visit (30-45 minutes)
description: We will examine the effectiveness of CAM therapies on self-reported (11 point scale) pain measured just before and immediately after service delivery.
measure: Effects of selected CAM therapies on duration of pain change.
time frame: 5 hours
description: We will examine the effectiveness of CAM therapies on repeated measures of self-reported pain over several hours after therapy to assess the distribution and decay of the pain change effect.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffery Dusek, PhD
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Sponsor