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

NCT ID: NCT02202096

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28

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.

Conditions

Colorectal Cancer; Comprehensive Transitional Care Program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL

Study Groups

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

Group Type: EXPERIMENTAL

Patient education: One-on-one visit

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Patient-centered discharge instructions: Enhanced

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Usual Care

Usual care-Standard of care that all colorectal cancer patients normally receive

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient education: One-on-one visit

The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.

Intervention Type: 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.

Intervention Type: OTHER

Medication reconciliation: Patient medication review

The navigator will review the patient's medications with him/her prior to discharge.

Intervention Type: 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.

Intervention Type: OTHER

Transition coach

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Lillian Kao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian S Kao, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-13-0336

Identifier Type: -

Identifier Source: org_study_id