Clinical trial NCT02658123: Reducing Readmissions in High-Risk Ostomates
Official title: Reducing Readmissions in High-Risk Ostomates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Within the first 30 days after hospital charge (up to approximately 37 days)
measure: 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
timeFrame: Within the first 30 days after hospital charge (up to approximately 37 days)
measure: 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
timeFrame: Within the first 30 days after hospital charge (up to approximately 37 days)
Secondary outcomes:
measure: Impact that the early telephone follow-up and evaluation have on the number of office visits
timeFrame: First 30 days after hospital discharge (approximately 37-52 days after admission)
measure: impact that the early telephone follow-up and evaluation have on the number of phone calls to the office
timeFrame: First 30 days after hospital discharge (approximately 37-52 days after admission)
measure: Impact that the early telephone follow-up and evaluation have on durable medical equipment (DME) usage
timeFrame: 30-day CWOCN visit (approximately 37-52 days after admission)
measure: Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score
timeFrame: 30-day CWOCN visit (approximately 37-52 days after admission)
measure: Impact that the early telephone follow-up and evaluation have on the scores of QOL (quality of life) questionnaire
timeFrame: 30-day clinical visit (approximately 37-52 days after admission)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Steven R Hunt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: