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

Colorectal Cancer Clinical Trial

Official title:

A Pilot Randomized Trial of the Comprehensive Transitional Care Program for Medically Underserved Colorectal Cancer Surgery Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02202096
• Other study ID #: HSC-MS-13-0336
• Status: Withdrawn
• Phase: N/A
• First received: May 19, 2014
• Last updated: June 13, 2016
• Start date: February 2015

Study information

• Verified date: June 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Comprehensive Transitional Care Program

Intervention

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.
• 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.
• Medication reconciliation: Patient medication review
The navigator will review the patient's medications with him/her prior to discharge.
• 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.
• Transition coach
The navigator will assist with coordination of care and tracking follow-up appointments and tests.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of post-operative ER visits and readmissions	The number of times the patient returned to the ER and/or was readmitted to the hospital withing 30 days following their surgery	up to 30 days postoperatively	No