Reducing Readmissions in High-Risk Ostomates

Not Applicable

Terminated

• Conditions: Ileostomy

• Registration Number: NCT02658123
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Study Start: 2016-04
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 peristomal skin irritation DET score	30-day CWOCN visit (approximately 37-52 days after admission)	-PeriPeristomal Skin Assessment/DET score based on discoloration, severity of discoloration, erosion, severity of erosion, tissue overgrowth, and severity of tissue overgrowth
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)
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)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States