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

University of Southern California

Status and phase: Unknown; Phase 3

Conditions: Ileostomy - Stoma; Colostomy Stoma

Treatments: Other: Ostomy Education Video; Other: Control - Standard ostomy education

Study type: Interventional

Funder types: Other

Identifiers

NCT03707392

HS-17-00982

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Other: Control - Standard ostomy education

Treatment

Experimental group

Description:

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

Treatment:

Other: Ostomy Education Video