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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Comprehensive Transitional Care Program
• Intervention / Treatment: 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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HSC-MS-13-0336