Reducing Readmissions in High-Risk Ostomates

Study Overview
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Brief Summary
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Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is available, and potentially improve both short and long-term quality of life (QOL) for patients by reducing morbidity and mortality associated with ostomy surgery. The purpose of this study is to measure the effectiveness of patient centered interventions/care pathways and to determine the impact on healthcare utilization, 30-day hospital readmissions, and QOL.

Official Title
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Reducing Readmissions in High-Risk Ostomates

Conditions
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Ileostomy

Intervention / Treatment
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* Other: Pre-operative education (standard of care)
* Other: Home health care visits (standard of care)
* Other: Follow-up post-operative visits
* Other: Patient Data Collection Form
* Other: Healthcare Utilization Form
* Other: The City of Hope QOL Survey for Ostomy Patients
* Other: Phone call with CWOCN or PA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo surgery that will result in the creation of an ileostomy. Agreed to receive home healthcare. At least 18 years of age. Speaks English. Has access to telephone. Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: -Unwilling or unable to receive home health care.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Standard of care<br>Standard of care pre-operative education Standard of care home health visits Standard of care follow-up post-operative visits with surgeon and CWOCN At 30-days post hospital discharge, the participant will: See the physician Turn in Patient Data Collection Form Turn in Healthcare Utilization Form Complete The City of Hope QOL Survey for Ostomy Patients Ostomy assessment with a CWOCN, including photo of ostomy site | Other: Pre-operative education (standard of care)<br> <br> Other: Home health care visits (standard of care)<br> <br> Other: Follow-up post-operative visits<br> <br> Other: Patient Data Collection Form<br>* -Form that contains date, area to record number of pouches, and if home health care visit took place.<br>Other: Healthcare Utilization Form<br>* Form for patient to record if they visited an emergency room or urgent care or if they were hospitalized Form allows patient to record reason for visit and date of visit<br>Other: The City of Hope QOL Survey for Ostomy Patients<br>* Consists of 47 questions asking various physical, psychological, sexual, work-related, and demographic questions. Additional 34 questions on how the ostomy affects quality of life. Answers range from 0=not at all to 10=severe problem.<br>|
| Experimental: Group B: Phone call<br>Standard of care pre-operative education Standard of care home health visits Standard of care follow-up post-operative visits with surgeon and CWOCN Telephone call 48-72 hours post-discharge from CWOCN/PA to evaluate tolerability to foods/fluids, activity level, screen for red-flags, review/assess for medication, reviewing pouching of ostomy, review patient's ability to obtain supplies, provide continued education, discuss proper use of durable medical equipment/frequency of pouch changes, and complete Patient Assessment Form. At 30-days post hospital discharge, the participant will: See the physician Turn in Patient Data Collection Form Turn in Healthcare Utilization Form Complete The City of Hope QOL Survey for Ostomy Patients Ostomy assessment with a CWOCN, including photo of ostomy site | Other: Pre-operative education (standard of care)<br> <br> Other: Home health care visits (standard of care)<br> <br> Other: Follow-up post-operative visits<br> <br> Other: Patient Data Collection Form<br>* -Form that contains date, area to record number of pouches, and if home health care visit took place.<br>Other: Healthcare Utilization Form<br>* Form for patient to record if they visited an emergency room or urgent care or if they were hospitalized Form allows patient to record reason for visit and date of visit<br>Other: The City of Hope QOL Survey for Ostomy Patients<br>* Consists of 47 questions asking various physical, psychological, sexual, work-related, and demographic questions. Additional 34 questions on how the ostomy affects quality of life. Answers range from 0=not at all to 10=severe problem.<br>Other: Phone call with CWOCN or PA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of early implementation of post-operative assessment by Certified Wound Ostomy Continence Nurse (CWOCN) or physician's assistant (PA) via follow-up telephone call on health care utilization as measured by number of emergency room visits |  | Within the first 30 days after hospital charge (up to approximately 37 days) | 
| Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of hospitalizations |  | Within the first 30 days after hospital charge (up to approximately 37 days) | 
| Impact of early implementation of post-operative assessment by CWOCN or PA via follow-up telephone call on health care utilization as measured by number of urgent care visits |  | Within the first 30 days after hospital charge (up to approximately 37 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact that the early telephone follow-up and evaluation have on the number of office visits |  | First 30 days after hospital discharge (approximately 37-52 days after admission) | 
| impact that the early telephone follow-up and evaluation have on the number of phone calls to the office |  | First 30 days after hospital discharge (approximately 37-52 days after admission) | 
| Impact that the early telephone follow-up and evaluation have on durable medical equipment (DME) usage |  | 30-day CWOCN visit (approximately 37-52 days after admission) | 
| Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score | -PeriPeristomal Skin Assessment/DET score based on discoloration, severity of discoloration, erosion, severity of erosion, tissue overgrowth, and severity of tissue overgrowth | 30-day CWOCN visit (approximately 37-52 days after admission) | 
| Impact that the early telephone follow-up and evaluation have on the scores of QOL (quality of life) questionnaire |  | 30-day clinical visit (approximately 37-52 days after admission) |