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

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.

Study Overview

• Status: Unknown
• Conditions: Ileostomy - Stoma; Colostomy Stoma
• Intervention / Treatment: Other: Control - Standard ostomy education; Other: Ostomy Education Video

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 Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: Kasim L Mirza, MD; Phone Number: 323-865-3690; Email: kasim.mirza@med.usc.edu
      • Contact: Carey Wickham, MD; Phone Number: 323-865-3690; Email: carey.wickham@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: stoma education
• Other Study ID Numbers: HS-17-00982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No