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Trial record 41 of 482 for:    colon cancer | ( Map: Texas, United States )

A Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02202096
Recruitment Status : Withdrawn (Resources were not readily available to begin the study.)
First Posted : July 28, 2014
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Lillian Kao, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Comprehensive Transitional Care Program Other: Patient education: One-on-one visit Other: Discharge planning: Assessment of barriers to discharge Other: Medication reconciliation: Patient medication review Other: Appointment before discharge: Additional measure to ensure awareness of next clinic visit Other: Transition coach Other: Patient-centered discharge instructions: Enhanced Other: Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology Other: Timely follow-up: Barriers to clinic follow-up visits will be discussed Other: Timely PCP communication Other: Follow-up telephone call Other: Patient hotline: 24 hour follow-up following call to Ask My Nurse number Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: A Pilot Randomized Trial of the Comprehensive Transitional Care Program for Medically Underserved Colorectal Cancer Surgery Patients
Study Start Date : February 2015
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention (plus usual care)
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
Other: Patient education: One-on-one visit
The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.

Other: Discharge planning: Assessment of barriers to discharge
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.

Other: Medication reconciliation: Patient medication review
The navigator will review the patient's medications with him/her prior to discharge.

Other: Appointment before discharge: Additional measure to ensure awareness of next clinic visit
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.

Other: Transition coach
The navigator will assist with coordination of care and tracking follow-up appointments and tests.

Other: Patient-centered discharge instructions: Enhanced
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.

Other: Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology
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.

Other: Timely follow-up: Barriers to clinic follow-up visits will be discussed
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.

Other: Timely PCP communication
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.

Other: Follow-up telephone call
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.

Other: Patient hotline: 24 hour follow-up following call to Ask My Nurse number
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.

No Intervention: Usual Care
Usual care-Standard of care that all colorectal cancer patients normally receive



Primary Outcome Measures :
  1. Number of post-operative ER visits and readmissions [ Time Frame: up to 30 days postoperatively ]
    The number of times the patient returned to the ER and/or was readmitted to the hospital withing 30 days following their surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of colorectal cancer
  • Adults, Age 18 years or older
  • Undergoing surgery for either palliative cure or palliation

Exclusion Criteria:

  • Patients not expected to survive hospital based on the operating surgeon's opinion
  • Children under the age of 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202096


Locations
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United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Lillian S Kao, MD, MS The University of Texas Health Science Center, Houston

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Responsible Party: Lillian Kao, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02202096     History of Changes
Other Study ID Numbers: HSC-MS-13-0336
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases