Different Levels of Patient Education for Care of Ostomy Site

Study Overview
=================
Brief Summary
-----------------
This is a randomized study of standard versus extra ostomy education.

Detailed Description
-----------------
The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.

Official Title
-----------------
A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life

Conditions
-----------------
Ostomy

Intervention / Treatment
-----------------
* Behavioral: Standard
* Behavioral: Pre-operative Education
* Behavioral: Two-week Post Operative Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal to or greater than 18 years of age at the time of consent. Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process. Are willing and able to provide written informed consent for participation in the study and authorization for release of health information. Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care. Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy. Subjects who do NOT have any history of prior colostomy or ileostomy. Exclusion Criteria: Subjects not meeting any of the above eligibility criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Subjects will receive standard ostomy education. | Behavioral: Standard<br>* Standard ostomy education<br>|
| Experimental: Pre-Operative Education<br>In addition to standard ostomy education, subjects will receive additional education pre-operatively. | Behavioral: Standard<br>* Standard ostomy education<br>Behavioral: Pre-operative Education<br>* In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.<br>|
| Experimental: Two-week Post Operative Education<br>In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. | Behavioral: Standard<br>* Standard ostomy education<br>Behavioral: Pre-operative Education<br>* In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.<br>Behavioral: Two-week Post Operative Education<br>* In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Assessed by Stoma Quality of Life Scale and Stoma Care Self-Efficacy Scale | Six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Ostomy education, care of ostomy site