IleostomyNCT02658123
Reducing Readmissions in High-Risk Ostomates
A study testing Follow-up post-operative visits, Patient Data Collection Form and Healthcare Utilization Form in people with Ileostomy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is available, and potentially improve both short and long-term quality of life (QOL) for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- Follow-up post-operative visits, Patient Data Collection Form and Healthcare Utilization Form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 22 Aug 2018
- 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
- Scheduled to undergo surgery that will result in the creation of an ileostomy.
- Agreed to receive home healthcare.
- At least 18 years of age.
- Speaks English.
- Has access to telephone.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Who cannot join
- -Unwilling or unable to receive home health care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is available, and potentially improve both short and long-term quality of life (QOL) for patients by reducing morbidity and mortality associated with ostomy surgery. The purpose of this study is to measure the effectiveness of patient centered interventions/care pathways and to determine the impact on healthcare utilization, 30-day hospital readmissions, and QOL.
- Conditions
- Ileostomy
- Being tested
- Pre-operative education (standard of care), Home health care visits (standard of care), Follow-up post-operative visits, Patient Data Collection Form, Healthcare Utilization Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative education (standard of care)Other
Home health care visits (standard of care)Other
Follow-up post-operative visitsOther
Patient Data Collection FormOther
-Form that contains date, area to record number of pouches, and if home health care visit took place.
Healthcare Utilization FormOther
- Form for patient to record if they visited an emergency room or urgent care or if they were hospitalized
- Form allows patient to record reason for visit and date of visit
The City of Hope QOL Survey for Ostomy PatientsOther
- Consists of 47 questions asking various physical, psychological, sexual, work-related, and demographic questions.
- Additional 34 questions on how the ostomy affects quality of life. Answers range from 0=not at all to 10=severe problem.
Phone call with CWOCN or PAOther
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard of care | Active comparator | * Standard of care pre-operative education
* Standard of care home health visits
* Standard of care follow-up post-operative visits with surgeon and CWOCN
* At 30-days post hospital discharge, the participant will:
* See the physician
* Turn in Patient Data Collection Form
* Turn in Healthcare Utilization Form
* Complete The City of Hope QOL Survey for Ostomy Patients
* Ostomy assessment with a CWOCN, including photo of ostomy site Receives: Other: Pre-operative education (standard of care); Other: Home health care visits (standard of care); Other: Follow-up post-operative visits; Other: Patient Data Collection Form; Other: Healthcare Utilization Form; Other: The City of Hope QOL Survey for Ostomy Patients |
| Group B: Phone call | Experimental | * Standard of care pre-operative education
* Standard of care home health visits
* Standard of care follow-up post-operative visits with surgeon and CWOCN
* Telephone call 48-72 hours post-discharge from CWOCN/PA to evaluate tolerability to foods/fluids, activity level, screen for red-flags, review/assess for medication, reviewing pouching of ostomy, review patient's ability to obtain supplies, provide continued education, discuss proper use of durable medical equipment/frequency of pouch changes, and complete Patient Assessment Form.
* At 30-days post hospital discharge, the participant will:
* See the physician
* Turn in Patient Data Collection Form
* Turn in Healthcare Utilization Form
* Complete The City of Hope QOL Survey for Ostomy Patients
* Ostomy assessment with a CWOCN, including photo of ostomy site Receives: Other: Pre-operative education (standard of care); Other: Home health care visits (standard of care); Other: Follow-up post-operative visits; Other: Patient Data Collection Form; Other: Healthcare Utilization Form; Other: The City of Hope QOL Survey for Ostomy Patients; Other: Phone call with CWOCN or PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of early implementation of post-operative assessment by Certified Wound Ostomy Continence Nurse (CWOCN) or physician's assistant (PA) via follow-up telephone call on health care utilization as measured by number of emergency room visits
Measured: Within the first 30 days after hospital charge (up to approximately 37 days)
Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of hospitalizations
Measured: Within the first 30 days after hospital charge (up to approximately 37 days)
Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of urgent care visits
Measured: Within the first 30 days after hospital charge (up to approximately 37 days)
Secondary outcomes (5)
Impact that the early telephone follow-up and evaluation have on the number of office visits
Measured: First 30 days after hospital discharge (approximately 37-52 days after admission)
impact that the early telephone follow-up and evaluation have on the number of phone calls to the office
Measured: First 30 days after hospital discharge (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on durable medical equipment (DME) usage
Measured: 30-day CWOCN visit (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score
-PeriPeristomal Skin Assessment/DET score based on discoloration, severity of discoloration, erosion, severity of erosion, tissue overgrowth, and severity of tissue overgrowth
Measured: 30-day CWOCN visit (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on the scores of QOL (quality of life) questionnaire
Measured: 30-day clinical visit (approximately 37-52 days after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: Decline in enrollment, lack of efficacy, and completion of funding accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Hunt, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658123
- Sponsor's protocol ID
- 201601014
- Status last verified
- Sep 2018
- First submitted
- 14 Jan 2016
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Readmissions in High-Risk Ostomates
- ClinicalTrials.gov ID
- NCT02658123
- Acronym / sponsor ID
- 201601014
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decline in enrollment, lack of efficacy, and completion of funding accrual
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 18 Jan 2016 (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.
Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is available, and potentially improve both short and long-term quality of life (QOL) for patients by reducing morbidity and mortality associated with ostomy surgery. The purpose of this study is to measure the effectiveness of patient centered interventions/care pathways and to determine the impact on healthcare utilization, 30-day hospital readmissions, and QOL.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard of care | Active comparator | Other: Pre-operative education (standard of care), Other: Home health care visits (standard of care), Other: Follow-up post-operative visits, Other: Patient Data Collection Form, Other: Healthcare Utilization Form, Other: The City of Hope QOL Survey for Ostomy Patients* Standard of care pre-operative education * Standard of care home health visits * Standard of care follow-up post-operative visits with surgeon and CWOCN * At 30-days post hospital discharge, the participant will: * See the physician * Turn in Patient Data Collection Form * Turn in Healthcare Utilization Form * Complete The City of Hope QOL Survey for Ostomy Patients * Ostomy assessment with a CWOCN, including photo of ostomy site |
| Group B: Phone call | Experimental | Other: Pre-operative education (standard of care), Other: Home health care visits (standard of care), Other: Follow-up post-operative visits, Other: Patient Data Collection Form, Other: Healthcare Utilization Form, Other: The City of Hope QOL Survey for Ostomy Patients, Other: Phone call with CWOCN or PA* Standard of care pre-operative education * Standard of care home health visits * Standard of care follow-up post-operative visits with surgeon and CWOCN * Telephone call 48-72 hours post-discharge from CWOCN/PA to evaluate tolerability to foods/fluids, activity level, screen for red-flags, review/assess for medication, reviewing pouching of ostomy, review patient's ability to obtain supplies, provide continued education, discuss proper use of durable medical equipment/frequency of pouch changes, and complete Patient Assessment Form. * At 30-days post hospital discharge, the participant will: * See the physician * Turn in Patient Data Collection Form * Turn in Healthcare Utilization Form * Complete The City of Hope QOL Survey for Ostomy Patients * Ostomy assessment with a CWOCN, including photo of ostomy site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo surgery that will result in the creation of an ileostomy.
- Agreed to receive home healthcare.
- At least 18 years of age.
- Speaks English.
- Has access to telephone.
Key exclusion criteria (1 listed)
- -Unwilling or unable to receive home health care.
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 |
|---|---|---|
| Pre-operative education (standard of care) | Other | Group A: Standard of care, Group B: Phone call |
| Home health care visits (standard of care) | Other | Group A: Standard of care, Group B: Phone call |
| Follow-up post-operative visits | Other | Group A: Standard of care, Group B: Phone call |
| Patient Data Collection Form-Form that contains date, area to record number of pouches, and if home health care visit took place. | Other | Group A: Standard of care, Group B: Phone call |
| Healthcare Utilization Form* Form for patient to record if they visited an emergency room or urgent care or if they were hospitalized * Form allows patient to record reason for visit and date of visit | Other | Group A: Standard of care, Group B: Phone call |
| The City of Hope QOL Survey for Ostomy Patients* Consists of 47 questions asking various physical, psychological, sexual, work-related, and demographic questions. * Additional 34 questions on how the ostomy affects quality of life. Answers range from 0=not at all to 10=severe problem. | Other | Group A: Standard of care, Group B: Phone call |
| Phone call with CWOCN or PA | Other | Group B: Phone call |
Primary outcome
Impact of early implementation of post-operative assessment by Certified Wound Ostomy Continence Nurse (CWOCN) or physician's assistant (PA) via follow-up telephone call on health care utilization as measured by number of emergency room visits
Time frame: Within the first 30 days after hospital charge (up to approximately 37 days)
Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of hospitalizations
Time frame: Within the first 30 days after hospital charge (up to approximately 37 days)
Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of urgent care visits
Time frame: Within the first 30 days after hospital charge (up to approximately 37 days)
5 secondary outcomes
Impact that the early telephone follow-up and evaluation have on the number of office visits
Time frame: First 30 days after hospital discharge (approximately 37-52 days after admission)
impact that the early telephone follow-up and evaluation have on the number of phone calls to the office
Time frame: First 30 days after hospital discharge (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on durable medical equipment (DME) usage
Time frame: 30-day CWOCN visit (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score
Time frame: 30-day CWOCN visit (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on the scores of QOL (quality of life) questionnaire
Time frame: 30-day clinical visit (approximately 37-52 days after admission)
Results and safety
The study was stopped early (reason given: Decline in enrollment, lack of efficacy, and completion of funding accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Steven R Hunt, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up post-operative visits, Patient Data Collection Form and Healthcare Utilization Form in people with Ileostomy, run by Washington University School of Medicine 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Oct 2018. 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 stopped early (reason given: Decline in enrollment, lack of efficacy, and completion of funding accrual). Results are not available in the source record.
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?
Impact of early implementation of post-operative assessment by Certified Wound Ostomy Continence Nurse (CWOCN) or physician's assistant (PA) via follow-up telephone call on health care utilization as measured by number of emergency room visits (time frame: Within the first 30 days after hospital charge (up to approximately 37 days)). The study lists 3 primary outcomes in all. 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 1 Oct 2018.