Colorectal CancerNCT02202096
A Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer Patients
A study testing Patient education: One-on-one visit, Discharge planning: Assessment of barriers to discharge and Medication reconciliation: Patient medication review in people with Colorectal Cancer and Comprehensive Transitional Care Program, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Comprehensive Transitional Care Program
- What is being tested?
- Patient education: One-on-one visit, Discharge planning: Assessment of barriers to discharge and Medication reconciliation: Patient medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of colorectal cancer
- Adults, Age 18 years or older
- Undergoing surgery for either palliative cure or palliation
Who cannot join
- Patients not expected to survive hospital based on the operating surgeon's opinion
- Children under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
Official title: 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.
- Being tested
- 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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education: One-on-one visitOther
The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.
Discharge planning: Assessment of barriers to dischargeOther
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 reviewOther
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 visitOther
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 coachOther
The navigator will assist with coordination of care and tracking follow-up appointments and tests.
Patient-centered discharge instructions: EnhancedOther
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 oncologyOther
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 discussedOther
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 communicationOther
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 callOther
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 numberOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (plus usual care) | Experimental | 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 Receives: 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 |
| Usual Care | No intervention | Usual care-Standard of care that all colorectal cancer patients normally receive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
Why it stopped: Resources were not readily available to begin the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian Kao, The University of Texas Health Science Center, Houston
- Investigators
- Lillian S Kao, MD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202096
- Sponsor's protocol ID
- HSC-MS-13-0336
- Status last verified
- Jun 2016
- First submitted
- 19 May 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of the Comprehensive Transitional Care Program for Medically Underserved Colorectal Cancer Surgery Patients
- ClinicalTrials.gov ID
- NCT02202096
- Acronym / sponsor ID
- HSC-MS-13-0336
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resources were not readily available to begin the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (plus usual care) | Experimental | 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 numberPatient 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 |
| Usual Care | No intervention | –Usual care-Standard of care that all colorectal cancer patients normally receive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of colorectal cancer
- Adults, Age 18 years or older
- Undergoing surgery for either palliative cure or palliation
Key exclusion criteria (2 listed)
- Patients not expected to survive hospital based on the operating surgeon's opinion
- Children under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education: One-on-one visitThe navigator or surgeon will have a one-on-one visit with he patient to answer any questions. | Other | Intervention (plus usual care) |
| Discharge planning: Assessment of barriers to dischargeCase 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 | Intervention (plus usual care) |
| Medication reconciliation: Patient medication reviewThe navigator will review the patient's medications with him/her prior to discharge. | Other | Intervention (plus usual care) |
| Appointment before discharge: Additional measure to ensure awareness of next clinic visitAdditional 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 | Intervention (plus usual care) |
| Transition coachThe navigator will assist with coordination of care and tracking follow-up appointments and tests. | Other | Intervention (plus usual care) |
| Patient-centered discharge instructions: EnhancedEnhanced, 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 | Intervention (plus usual care) |
| Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncologyDrs. 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 | Intervention (plus usual care) |
| Timely follow-up: Barriers to clinic follow-up visits will be discussedPatients 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 | Intervention (plus usual care) |
| Timely PCP communicationThe 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 | Intervention (plus usual care) |
| Follow-up telephone callPatients 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 | Intervention (plus usual care) |
| Patient hotline: 24 hour follow-up following call to Ask My Nurse numberFollow-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. | Other | Intervention (plus usual care) |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian S Kao, MD, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education: One-on-one visit, Discharge planning: Assessment of barriers to discharge and Medication reconciliation: Patient medication review in people with Colorectal Cancer and Comprehensive Transitional Care Program, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of post-operative ER visits and readmissions (time frame: up to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.