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

NCT03707392 | Unknown Phase 3

• 1 other identifier: HS-17-00982
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma; Colostomy Stoma

Keywords

stoma education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of stay

  through initial inpatient hospital stay: an average of 5 days

• Hospital Readmission

  within 30 days, and within 30-60 days postoperatively

• Phone Calls

  within 60 days of discharge

• Clinic/Urgent Care/Emergency Department visits

  within 60 days of discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Control - Standard ostomy education

Treatment

EXPERIMENTAL

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

Other: Ostomy Education Video

Interventions

Ostomy Education Video OTHER

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

Treatment

Control - Standard ostomy education OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults over 18 yrs of age
• undergoing elective surgery including plan for ileostomy or colostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Study Officials

• Sang W Lee, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasim L Mirza, MD

CONTACT

323-865-3690; kasim.mirza@med.usc.edu

Carey Wickham, MD

CONTACT

323-865-3690; carey.wickham@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 16, 2018
• Study Start: July 17, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)