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

Sponsor

University of Southern California (Other)

Overall Status

Unknown status

CT.gov ID

NCT03707392

Collaborator

(none)

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma Colostomy Stoma	Other: Ostomy Education Video Other: Control - Standard ostomy education	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 17, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials	Other: Control - Standard ostomy education Standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
Experimental: Treatment Ostomy care educational video combined with standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials	Other: Ostomy Education Video Ostomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials

Arm

Intervention/Treatment

Active Comparator: Control

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

Other: Control - Standard ostomy education

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

Experimental: Treatment

Ostomy care educational video combined with standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials

Other: Ostomy Education Video

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

Outcome Measures

Primary Outcome Measures

Delay in hospital discharge [through initial inpatient hospital stay: an average of 5 days]
Delay in hospital discharge due to need for additional ostomy teaching

Secondary Outcome Measures

Length of stay [through initial inpatient hospital stay: an average of 5 days]
overall length of inpatient hospitalization
Hospital Readmission [within 30 days, and within 30-60 days postoperatively]
rate of readmission to hospital after surgery
Phone Calls [within 60 days of discharge]
Number of phone calls to surgical team after discharge
Clinic/Urgent Care/Emergency Department visits [within 60 days of discharge]
number of Clinic/Urgent Care/Emergency Department visits

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

University of Southern California

Investigators

Principal Investigator: Sang W Lee, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sang Won Lee, Professor of Clinical Surgery, Chief, Division of Colorectal Surgery, University of Southern California

ClinicalTrials.gov Identifier:

NCT03707392

Other Study ID Numbers:

HS-17-00982

First Posted:

Oct 16, 2018

Last Update Posted:

Oct 16, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sang Won Lee, Professor of Clinical Surgery, Chief, Division of Colorectal Surgery, University of Southern California

stoma education

Study Results

No Results Posted as of Oct 16, 2018