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Trial record 10 of 562 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

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

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ClinicalTrials.gov Identifier: NCT03707392
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Won Lee, University of Southern California

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : July 17, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

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




Primary Outcome Measures :
  1. Delay in hospital discharge [ Time Frame: through initial inpatient hospital stay: an average of 5 days ]
    Delay in hospital discharge due to need for additional ostomy teaching


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: through initial inpatient hospital stay: an average of 5 days ]
    overall length of inpatient hospitalization

  2. Hospital Readmission [ Time Frame: within 30 days, and within 30-60 days postoperatively ]
    rate of readmission to hospital after surgery

  3. Phone Calls [ Time Frame: within 60 days of discharge ]
    Number of phone calls to surgical team after discharge

  4. Clinic/Urgent Care/Emergency Department visits [ Time Frame: within 60 days of discharge ]
    number of Clinic/Urgent Care/Emergency Department visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707392


Contacts
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Contact: Kasim L Mirza, MD 323-865-3690 kasim.mirza@med.usc.edu
Contact: Carey Wickham, MD 323-865-3690 carey.wickham@med.usc.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Kasim L Mirza, MD    323-865-3690    kasim.mirza@med.usc.edu   
Contact: Carey Wickham, MD    323-865-3690    carey.wickham@med.usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Sang W Lee, MD University of Southern California

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Responsible Party: Sang Won Lee, Professor of Clinical Surgery, Chief, Division of Colorectal Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT03707392     History of Changes
Other Study ID Numbers: HS-17-00982
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sang Won Lee, University of Southern California:
stoma education