<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/NCT03798405</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00050742</org_study_id>
    <nct_id>NCT03798405</nct_id>
  </id_info>
  <brief_title>Reactive vs. Proactive Pain Control in IBD</brief_title>
  <acronym>PAIN-Sparing</acronym>
  <official_title>Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 investigators will compare two physician behaviors for managing pain in patients with&#xD;
      IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard&#xD;
      of care at the institution in which the study will be performed. The PROACTIVE strategy is an&#xD;
      IBD-specific analgesic orderset (built into our EMR and approved by the institution's&#xD;
      Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional &quot;reactive&quot;&#xD;
      analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE&#xD;
      IBD-specific analgesic orderset consists of medications which have evidence for use in&#xD;
      IBD-related pain. This orderset is an educational guide, it does not force any order. The&#xD;
      reactive prescribing habits could contain an array of pain medications depending on what the&#xD;
      provider wants to prescribe.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      Aim 1: To assess whether there is a difference in pain scores or functional activity among&#xD;
      hospitalized patients with IBD between reactive vs proactive physician behaviors.&#xD;
&#xD;
      Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between&#xD;
      reactive vs proactive physician behaviors.&#xD;
&#xD;
      Aim 3: To assess whether there is a difference in health care utilization, including&#xD;
      length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive&#xD;
      adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will&#xD;
      be screened for eligibility, and eligible patients will be approached and consented to&#xD;
      participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual&#xD;
      care. Patient randomization will be stratified by provider to avoid bias, using a web-based&#xD;
      in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R))&#xD;
      to measure functional status during their hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19-related restrictions&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</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>Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score &gt; 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The primary investigators will be blinded, as will the computer programmers who collect the data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-Reported Pain Scores</measure>
    <time_frame>Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.</time_frame>
    <description>Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>From hospital admission until hospital discharge, typically 7 days.</time_frame>
    <description>Hospital length of stay (in days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Activity</measure>
    <time_frame>From hospital admission until hospital discharge, typically 7 days.</time_frame>
    <description>FitBit activity (number of steps per day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid-Consumption</measure>
    <time_frame>From hospital admission until hospital discharge, typically 7 days.</time_frame>
    <description>Milligram morphine-equivalents consumed per day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Pain</condition>
  <condition>Opioid Use</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Proactive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proactive Analgesic Inpatient Narcotic-Sparing:&#xD;
Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a &quot;protocol&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reactive (Control Group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Proactive Analgesic Inpatient Narcotic-Sparing</intervention_name>
    <description>Medications suggested to the physician with enhanced ease of ordering.</description>
    <arm_group_label>Proactive</arm_group_label>
    <other_name>P.A.I.N.-Sparing Bundle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with confirmed IBD diagnosis&#xD;
&#xD;
          -  Admitted for primary IBD-related sign or symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admitted for primary non-IBD complaint&#xD;
&#xD;
          -  Surgery in the last 30 days&#xD;
&#xD;
          -  Alternative (non-IBD) GI diagnosis determined&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Pregnancy&#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>Gil Y Melmed, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sameer K Berry, MD, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Gil Melmed</investigator_full_name>
    <investigator_title>co-Director, Inflammatory Bowel Disease Center, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>Opioids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Narcotics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03798405
org study id: Pro00050742
nct id: NCT03798405
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will compare two physician behaviors for managing pain in patients with
      IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard
      of care at the institution in which the study will be performed. The PROACTIVE strategy is an
      IBD-specific analgesic orderset (built into our EMR and approved by the institution's
      Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive"
      analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE
      IBD-specific analgesic orderset consists of medications which have evidence for use in
      IBD-related pain. This orderset is an educational guide, it does not force any order. The
      reactive prescribing habits could contain an array of pain medications depending on what the
      provider wants to prescribe.

      Aims:

      Aim 1: To assess whether there is a difference in pain scores or functional activity among
      hospitalized patients with IBD between reactive vs proactive physician behaviors.

      Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between
      reactive vs proactive physician behaviors.

      Aim 3: To assess whether there is a difference in health care utilization, including
      length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive
      adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will
      be screened for eligibility, and eligible patients will be approached and consented to
      participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual
      care. Patient randomization will be stratified by provider to avoid bias, using a web-based
      in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R))
      to measure functional status during their hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score > 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: The primary investigators will be blinded, as will the computer programmers who collect the data.
measure: Patient-Reported Pain Scores
time frame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
description: Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
measure: Healthcare Utilization
time frame: From hospital admission until hospital discharge, typically 7 days.
description: Hospital length of stay (in days)
measure: Functional Activity
time frame: From hospital admission until hospital discharge, typically 7 days.
description: FitBit activity (number of steps per day)
measure: Opioid-Consumption
time frame: From hospital admission until hospital discharge, typically 7 days.
description: Milligram morphine-equivalents consumed per day
arm group label: Proactive
arm group type: Experimental
description: Proactive Analgesic Inpatient Narcotic-Sparing:
Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol".
arm group label: Reactive (Control Group)
arm group type: No Intervention
description: Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.
intervention type: Behavioral
intervention name: Proactive Analgesic Inpatient Narcotic-Sparing
description: Medications suggested to the physician with enhanced ease of ordering.
arm group label: Proactive
other name: P.A.I.N.-Sparing Bundle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gil Y Melmed, MD, MS
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Sameer K Berry, MD, MBA
role: Study Director
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Gil Melmed
investigator title: co-Director, Inflammatory Bowel Disease Center, Principal Investigator
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Analgesics
mesh term: Narcotics
sharing ipd: No