Reducing Readmissions in High-Risk Ostomates

Ileostomy Clinical Trial

Official title:

Reducing Readmissions in High-Risk Ostomates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02658123
• Other study ID #: 201601014
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: September 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Ileostomy

Intervention

Other:
• Pre-operative education (standard of care)

• Home health care visits (standard of care)

• Follow-up post-operative visits

• Patient Data Collection Form
-Form that contains date, area to record number of pouches, and if home health care visit took place.
• Healthcare 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
• The 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.
• Phone call with CWOCN or PA

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine