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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03707392
Other study ID # HS-17-00982
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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