Ileostomy - StomaPhase 3NCT03707392
A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
A Phase 3 study testing Ostomy Education Video in people with Ileostomy - Stoma and Colostomy Stoma, run by University of Southern California at 1 site in United States.
Trial summary
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma, Colostomy Stoma
- What is being tested?
- Ostomy Education Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 1 Jan 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults over 18 yrs of age
- undergoing elective surgery including plan for ileostomy or colostomy
Who cannot join
- patients unable or unwilling to provide informed consent for any reason, including patients with inadequate capacity for decision making.
- Patients undergoing emergent surgery
- Vulnerable populations such as prison and psychiatric ward patients
- Patients who for any reason do not undergo construction of pre-operatively planned stoma
- Patients with history of previous stoma creation
- Patients who are not their own primary caregivers will also be excluded, including those patients who are planned to be discharged to care facility or nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Kasim L Mirza, MD, 323-865-3690, kasim.mirza@med.usc.edu
Carey Wickham, MD, 323-865-3690, carey.wickham@med.usc.edu
About this study
Official title: Quality Outcomes of Ostomy Teaching: A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.
Read the detailed description
Adult patients without prior history of ostomy, undergoing surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Patients will be consented and randomized at the time of preoperative clinic visit. All patients will receive standard preoperative ostomy teaching materials and education from the surgeon and clinic nurse. Patients randomized to the treatment arm will receive additional take-home teaching materials based on the American College of Surgeons Ostomy Teaching videos.
After post-operative inpatient ostomy-nurse teaching, and prior to discharge from the hospital, patients will fill out a survey detailing their level of comfort with various aspects of ostomy home care. Patients in the treatment arm will be be asked to review the ostomy teaching videos and fill out the survey prior to discharge. Primary outcome will be delay in discharge from hospital due to stoma-teaching related issues. Secondary outcomes will include rate of calls to the clinic for stoma-related questions, stoma-related clinic/urgent care/emergency department visits, and stoma-related complications.
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Being tested
- Ostomy Education Video, Control - Standard ostomy education
- Keywords
- stoma education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy Education VideoOther
Ostomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
Control - Standard ostomy educationOther
Standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials Receives: Other: Control - Standard ostomy education |
| Treatment | Experimental | Ostomy care educational video combined with standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials Receives: Other: Ostomy Education Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in hospital discharge
Delay in hospital discharge due to need for additional ostomy teaching
Measured: through initial inpatient hospital stay: an average of 5 days
Secondary outcomes (4)
Length of stay
overall length of inpatient hospitalization
Measured: through initial inpatient hospital stay: an average of 5 days
Hospital Readmission
rate of readmission to hospital after surgery
Measured: within 30 days, and within 30-60 days postoperatively
Phone Calls
Number of phone calls to surgical team after discharge
Measured: within 60 days of discharge
Clinic/Urgent Care/Emergency Department visits
number of Clinic/Urgent Care/Emergency Department visits
Measured: within 60 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start17 Jul 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Won Lee, University of Southern California
- Investigators
- Sang W Lee, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707392
- Sponsor's protocol ID
- HS-17-00982
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Outcomes of Ostomy Teaching: A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
- ClinicalTrials.gov ID
- NCT03707392
- Acronym / sponsor ID
- HS-17-00982
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Keywords
- stoma education
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 16 Oct 2018 (actual)
- 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.
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.
Detailed description
Adult patients without prior history of ostomy, undergoing surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Patients will be consented and randomized at the time of preoperative clinic visit. All patients will receive standard preoperative ostomy teaching materials and education from the surgeon and clinic nurse. Patients randomized to the treatment arm will receive additional take-home teaching materials based on the American College of Surgeons Ostomy Teaching videos.
After post-operative inpatient ostomy-nurse teaching, and prior to discharge from the hospital, patients will fill out a survey detailing their level of comfort with various aspects of ostomy home care. Patients in the treatment arm will be be asked to review the ostomy teaching videos and fill out the survey prior to discharge. Primary outcome will be delay in discharge from hospital due to stoma-teaching related issues. Secondary outcomes will include rate of calls to the clinic for stoma-related questions, stoma-related clinic/urgent care/emergency department visits, and stoma-related complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control - Standard ostomy educationStandard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials |
| Treatment | Experimental | Other: Ostomy Education VideoOstomy care educational video combined with standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults over 18 yrs of age
- undergoing elective surgery including plan for ileostomy or colostomy
Key exclusion criteria (6 listed)
- patients unable or unwilling to provide informed consent for any reason, including patients with inadequate capacity for decision making.
- Patients undergoing emergent surgery
- Vulnerable populations such as prison and psychiatric ward patients
- Patients who for any reason do not undergo construction of pre-operatively planned stoma
- Patients with history of previous stoma creation
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 |
|---|---|---|
| Ostomy Education VideoOstomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials | Other | Treatment |
| Control - Standard ostomy educationStandard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials | Other | Control |
Primary outcome
Delay in hospital discharge
Time frame: through initial inpatient hospital stay: an average of 5 days
Delay in hospital discharge due to need for additional ostomy teaching
4 secondary outcomes
Length of stay
Time frame: through initial inpatient hospital stay: an average of 5 days
Hospital Readmission
Time frame: within 30 days, and within 30-60 days postoperatively
Phone Calls
Time frame: within 60 days of discharge
Clinic/Urgent Care/Emergency Department visits
Time frame: within 60 days of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Sang W Lee, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ostomy Education Video in people with Ileostomy - Stoma and Colostomy Stoma, run by University of Southern California 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasim L Mirza, MD (323-865-3690, kasim.mirza@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in hospital discharge (time frame: through initial inpatient hospital stay: an average of 5 days). 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 16 Oct 2018.