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

NCT ID: NCT03707392

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2020-01-01

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.

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.

Conditions

Ileostomy - Stoma; Colostomy Stoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Control - Standard ostomy education

Intervention Type: OTHER

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

Treatment

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

Group Type: EXPERIMENTAL

Ostomy Education Video

Intervention Type: OTHER

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

Interventions

Ostomy Education Video

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

Intervention Type: OTHER

Control - Standard ostomy education

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Sang Won Lee

Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang W Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kasim L Mirza, MD

Role: CONTACT

kasim.mirza@med.usc.edu

323-865-3690

Carey Wickham, MD

Role: CONTACT

carey.wickham@med.usc.edu

323-865-3690

Facility Contacts

Kasim L Mirza, MD

Role: primary

kasim.mirza@med.usc.edu

323-865-3690

Carey Wickham, MD

Role: backup

carey.wickham@med.usc.edu

323-865-3690

Other Identifiers

HS-17-00982

Identifier Type: -

Identifier Source: org_study_id