Reducing Readmissions in High-Risk Ostomates

The Washington University

Status: Terminated

Conditions: Ileostomy

Treatments: Other: Phone call with CWOCN or PA; Other: The City of Hope QOL Survey for Ostomy Patients; Other: Follow-up post-operative visits; Other: Patient Data Collection Form; Other: Healthcare Utilization Form; Other: Home health care visits (standard of care); Other: Pre-operative education (standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT02658123

201601014

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Group A: Standard of care

Active Comparator group

Description:

* Standard of care pre-operative education * Standard of care home health visits * Standard of care follow-up post-operative visits with surgeon and CWOCN * At 30-days post hospital discharge, the participant will: * See the physician * Turn in Patient Data Collection Form * Turn in Healthcare Utilization Form * Complete The City of Hope QOL Survey for Ostomy Patients * Ostomy assessment with a CWOCN, including photo of ostomy site

Treatment:

Other: Healthcare Utilization Form

Other: Home health care visits (standard of care)

Other: The City of Hope QOL Survey for Ostomy Patients

Other: Follow-up post-operative visits

Other: Patient Data Collection Form

Other: Pre-operative education (standard of care)

Group B: Phone call

Experimental group

Description:

* Standard of care pre-operative education * Standard of care home health visits * Standard of care follow-up post-operative visits with surgeon and CWOCN * Telephone call 48-72 hours post-discharge from CWOCN/PA to evaluate tolerability to foods/fluids, activity level, screen for red-flags, review/assess for medication, reviewing pouching of ostomy, review patient's ability to obtain supplies, provide continued education, discuss proper use of durable medical equipment/frequency of pouch changes, and complete Patient Assessment Form. * At 30-days post hospital discharge, the participant will: * See the physician * Turn in Patient Data Collection Form * Turn in Healthcare Utilization Form * Complete The City of Hope QOL Survey for Ostomy Patients * Ostomy assessment with a CWOCN, including photo of ostomy site

Treatment:

Other: Healthcare Utilization Form

Other: Phone call with CWOCN or PA

Other: Home health care visits (standard of care)

Other: The City of Hope QOL Survey for Ostomy Patients

Other: Follow-up post-operative visits

Other: Patient Data Collection Form

Other: Pre-operative education (standard of care)