<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/NCT02202096</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-13-0336</org_study_id>
    <nct_id>NCT02202096</nct_id>
  </id_info>
  <brief_title>A Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer Patients</brief_title>
  <official_title>A Pilot Randomized Trial of the Comprehensive Transitional Care Program for Medically Underserved Colorectal Cancer Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary hypothesis is that a comprehensive transitional care program based on the premise&#xD;
      of a patient-centered medical home versus routine care reduces emergency room visits and&#xD;
      hospital readmissions without increasing costs among cancer patients undergoing surgery at a&#xD;
      large safety-net hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Resources were not readily available to begin the study.&#xD;
  </why_stopped>
  <start_date>February 2015</start_date>
  <primary_completion_date type="Anticipated">February 2016</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>
  </study_design_info>
  <primary_outcome>
    <measure>Number of post-operative ER visits and readmissions</measure>
    <time_frame>up to 30 days postoperatively</time_frame>
    <description>The number of times the patient returned to the ER and/or was readmitted to the hospital withing 30 days following their surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Comprehensive Transitional Care Program</condition>
  <arm_group>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient education: One-on-one visit Discharge planning: Assessment of barriers to discharge Medication reconciliation: Patient medication review Appointment before discharge: Additional measure to ensure awareness of next clinic visit Transition coach Patient-centered discharge instructions: Enhanced Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology Timely follow-up: Barriers to clinic follow-up visits will be discussed Timely PCP communication Follow-up telephone call Patient hotline: 24 hour follow-up following call to Ask My Nurse number</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care-Standard of care that all colorectal cancer patients normally receive</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient education: One-on-one visit</intervention_name>
    <description>The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discharge planning: Assessment of barriers to discharge</intervention_name>
    <description>Case management will be consulted on the day of surgery. The navigator will perform an assessment of barriers to discharge based on one-on-one interviews with the patient.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication reconciliation: Patient medication review</intervention_name>
    <description>The navigator will review the patient's medications with him/her prior to discharge.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Appointment before discharge: Additional measure to ensure awareness of next clinic visit</intervention_name>
    <description>Additional measures to ensure that patients are aware of the date, time, and place of their clinic visit(s) may include a phone calls or text messages to patients and their caregivers by the navigator, surgeon or clinic nurse.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transition coach</intervention_name>
    <description>The navigator will assist with coordination of care and tracking follow-up appointments and tests.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-centered discharge instructions: Enhanced</intervention_name>
    <description>Enhanced, language-specific, discharge instructions will be developed and provided to all patients verbally and in a written format designed for patients with limited literacy skills.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology</intervention_name>
    <description>Drs. Stefanos Millas (colorectal surgery) and Curtis Wray (surgical oncology) will be responsible for coordinating care with medical and radiation oncology as well as consulting when patients are readmitted to the hospital (if not admitted to the surgical service). Changes will be made to the clinic scheduling process for colorectal cancer surgery patients to minimize wait times, to allow them to be seen on a &quot;walk-in&quot; basis, and to prioritize visits for patients with urgent problems as identified by follow-up calls or inquiries to the Ask My Nurse hotline.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Timely follow-up: Barriers to clinic follow-up visits will be discussed</intervention_name>
    <description>Patients will be queried about financial barriers to clinic follow-up such as lack of money for parking and/or lack of transportation; parking vouchers and taxi/bus vouchers may be provided.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Timely PCP communication</intervention_name>
    <description>The operating surgeon will phone the PCP prior to and upon discharge to discuss concerns and follow-up care plans. Communication via the electronic medical record (EPIC) will also be sent. If the patient does not have a PCP, a referral will be made prior at the initial clinic visit and one provided.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up telephone call</intervention_name>
    <description>Patients will be contacted by phone by the navigator or surgeon on post-discharge day 1 to identify and address any concerns. If there are concerns, calls may be made on subsequent post-operative days.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient hotline: 24 hour follow-up following call to Ask My Nurse number</intervention_name>
    <description>Follow-up will occur within 24 hours of calling the Ask My Nurse number. Patients with emergent problems will be seen immediately by the surgical oncology team if available or the on call surgery team. Patients with non-urgent matters will be called by a member of the surgical oncology team. Arrangements will be made to see the patient in clinic or the ER within the next 8-16 hours depending upon severity and time of day.</description>
    <arm_group_label>Intervention (plus usual care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of colorectal cancer&#xD;
&#xD;
          -  Adults, Age 18 years or older&#xD;
&#xD;
          -  Undergoing surgery for either palliative cure or palliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not expected to survive hospital based on the operating surgeon's opinion&#xD;
&#xD;
          -  Children under the age of 18 years&#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>Lillian S Kao, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lyndon B. Johnson General Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>May 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>June 13, 2016</last_update_submitted>
  <last_update_submitted_qc>June 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Lillian Kao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02202096
org study id: HSC-MS-13-0336
nct id: NCT02202096
lead sponsor: 
has dmc: No
The primary hypothesis is that a comprehensive transitional care program based on the premise
      of a patient-centered medical home versus routine care reduces emergency room visits and
      hospital readmissions without increasing costs among cancer patients undergoing surgery at a
      large safety-net hospital.
allocation: Randomized
intervention model: Parallel Assignment
measure: Number of post-operative ER visits and readmissions
time frame: up to 30 days postoperatively
description: The number of times the patient returned to the ER and/or was readmitted to the hospital withing 30 days following their surgery
arm group label: Intervention (plus usual care)
arm group type: Experimental
description: Patient education: One-on-one visit Discharge planning: Assessment of barriers to discharge Medication reconciliation: Patient medication review Appointment before discharge: Additional measure to ensure awareness of next clinic visit Transition coach Patient-centered discharge instructions: Enhanced Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology Timely follow-up: Barriers to clinic follow-up visits will be discussed Timely PCP communication Follow-up telephone call Patient hotline: 24 hour follow-up following call to Ask My Nurse number
arm group label: Usual Care
arm group type: No Intervention
description: Usual care-Standard of care that all colorectal cancer patients normally receive
intervention type: Other
intervention name: Patient education: One-on-one visit
description: The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Discharge planning: Assessment of barriers to discharge
description: Case management will be consulted on the day of surgery. The navigator will perform an assessment of barriers to discharge based on one-on-one interviews with the patient.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Medication reconciliation: Patient medication review
description: The navigator will review the patient's medications with him/her prior to discharge.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Appointment before discharge: Additional measure to ensure awareness of next clinic visit
description: Additional measures to ensure that patients are aware of the date, time, and place of their clinic visit(s) may include a phone calls or text messages to patients and their caregivers by the navigator, surgeon or clinic nurse.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Transition coach
description: The navigator will assist with coordination of care and tracking follow-up appointments and tests.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Patient-centered discharge instructions: Enhanced
description: Enhanced, language-specific, discharge instructions will be developed and provided to all patients verbally and in a written format designed for patients with limited literacy skills.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology
description: Drs. Stefanos Millas (colorectal surgery) and Curtis Wray (surgical oncology) will be responsible for coordinating care with medical and radiation oncology as well as consulting when patients are readmitted to the hospital (if not admitted to the surgical service). Changes will be made to the clinic scheduling process for colorectal cancer surgery patients to minimize wait times, to allow them to be seen on a "walk-in" basis, and to prioritize visits for patients with urgent problems as identified by follow-up calls or inquiries to the Ask My Nurse hotline.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Timely follow-up: Barriers to clinic follow-up visits will be discussed
description: Patients will be queried about financial barriers to clinic follow-up such as lack of money for parking and/or lack of transportation; parking vouchers and taxi/bus vouchers may be provided.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Timely PCP communication
description: The operating surgeon will phone the PCP prior to and upon discharge to discuss concerns and follow-up care plans. Communication via the electronic medical record (EPIC) will also be sent. If the patient does not have a PCP, a referral will be made prior at the initial clinic visit and one provided.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Follow-up telephone call
description: Patients will be contacted by phone by the navigator or surgeon on post-discharge day 1 to identify and address any concerns. If there are concerns, calls may be made on subsequent post-operative days.
arm group label: Intervention (plus usual care)
intervention type: Other
intervention name: Patient hotline: 24 hour follow-up following call to Ask My Nurse number
description: Follow-up will occur within 24 hours of calling the Ask My Nurse number. Patients with emergent problems will be seen immediately by the surgical oncology team if available or the on call surgery team. Patients with non-urgent matters will be called by a member of the surgical oncology team. Arrangements will be made to see the patient in clinic or the ER within the next 8-16 hours depending upon severity and time of day.
arm group label: Intervention (plus usual care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lillian S Kao, MD, MS
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Lillian Kao
investigator title: Professor
mesh term: Colorectal Neoplasms