Ileostomy Clinical Trial
Official title:
Reducing Readmissions in High-Risk Ostomates
NCT number | NCT02658123 |
Other study ID # | 201601014 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | August 22, 2018 |
Verified date | September 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 94 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | 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) | ||
Primary | 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 | 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) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | |
Secondary | 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) |
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