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A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching

Quality Outcomes of Ostomy Teaching: A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03707392
Enrollment
74
Registered
2018-10-16
Start date
2018-07-17
Completion date
2020-01-01
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy Stoma, Ileostomy - Stoma

Keywords

stoma education

Brief 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. 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.

Interventions

OTHEROstomy Education Video

Ostomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials

OTHERControl - Standard ostomy education

Standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* adults over 18 yrs of age * undergoing elective surgery including plan for ileostomy or colostomy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Delay in hospital dischargethrough initial inpatient hospital stay: an average of 5 daysDelay in hospital discharge due to need for additional ostomy teaching

Secondary

MeasureTime frameDescription
Length of staythrough initial inpatient hospital stay: an average of 5 daysoverall length of inpatient hospitalization
Hospital Readmissionwithin 30 days, and within 30-60 days postoperativelyrate of readmission to hospital after surgery
Phone Callswithin 60 days of dischargeNumber of phone calls to surgical team after discharge
Clinic/Urgent Care/Emergency Department visitswithin 60 days of dischargenumber of Clinic/Urgent Care/Emergency Department visits

Countries

United States

Contacts

Primary ContactKasim L Mirza, MD
kasim.mirza@med.usc.edu323-865-3690
Backup ContactCarey Wickham, MD
carey.wickham@med.usc.edu323-865-3690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026