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

Ileostomy - Stoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03707392
• Other study ID #: HS-17-00982
• Status: Recruiting
• Phase: Phase 3
• Start date: July 17, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2018
• Source: University of Southern California
• Contact: Kasim L Mirza, MD
• Phone: 323-865-3690
• Email: kasim.mirza[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: January 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma

Intervention

Other:
• Ostomy Education Video
Ostomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
• Control - Standard ostomy education
Standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay in hospital discharge	Delay in hospital discharge due to need for additional ostomy teaching	through initial inpatient hospital stay: an average of 5 days
Secondary	Length of stay	overall length of inpatient hospitalization	through initial inpatient hospital stay: an average of 5 days
Secondary	Hospital Readmission	rate of readmission to hospital after surgery	within 30 days, and within 30-60 days postoperatively
Secondary	Phone Calls	Number of phone calls to surgical team after discharge	within 60 days of discharge
Secondary	Clinic/Urgent Care/Emergency Department visits	number of Clinic/Urgent Care/Emergency Department visits	within 60 days of discharge