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Reducing Readmissions in High-Risk Ostomates

Reducing Readmissions in High-Risk Ostomates

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02658123
Enrollment
94
Registered
2016-01-18
Start date
2016-04-30
Completion date
2018-08-22
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy

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.

Interventions

OTHERPre-operative education (standard of care)
OTHERHome health care visits (standard of care)
OTHERFollow-up post-operative visits
OTHERPatient Data Collection Form

-Form that contains date, area to record number of pouches, and if home health care visit took place.

OTHERHealthcare Utilization Form

* 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

OTHERThe City of Hope QOL Survey for Ostomy Patients

* 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.

OTHERPhone call with CWOCN or PA

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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 visitsWithin 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 hospitalizationsWithin 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 visitsWithin the first 30 days after hospital charge (up to approximately 37 days)

Secondary

MeasureTime frameDescription
Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score30-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 number of office visitsFirst 30 days after hospital discharge (approximately 37-52 days after admission)
Impact that the early telephone follow-up and evaluation have on the scores of QOL (quality of life) questionnaire30-day clinical visit (approximately 37-52 days after admission)
impact that the early telephone follow-up and evaluation have on the number of phone calls to the officeFirst 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) usage30-day CWOCN visit (approximately 37-52 days after admission)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026