Clinical trial NCT03707392: A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ileostomy - Stoma
Colostomy Stoma
Keywords: stoma education
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delay in hospital discharge
timeFrame: through initial inpatient hospital stay: an average of 5 days
Secondary outcomes:
measure: Length of stay
timeFrame: through initial inpatient hospital stay: an average of 5 days
measure: Hospital Readmission
timeFrame: within 30 days, and within 30-60 days postoperatively
measure: Phone Calls
timeFrame: within 60 days of discharge
measure: Clinic/Urgent Care/Emergency Department visits
timeFrame: within 60 days of discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Sang W Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: