Reducing Readmissions in High-Risk Ostomates

Not Applicable

Terminated

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

• Registration Number: NCT02658123
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Study Start: 2016-04
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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.

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Exclusion Criteria

-Unwilling or unable to receive home health care.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Standard of care	Follow-up post-operative visits	* 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
Group A: Standard of care	Healthcare Utilization Form	* 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
Group A: Standard of care	Home health care visits (standard of care)	* 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
Group B: Phone call	Home health care visits (standard of care)	* 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
Group A: Standard of care	Patient Data Collection Form	* 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
Group B: Phone call	Follow-up post-operative visits	* 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
Group A: Standard of care	Pre-operative education (standard of care)	* 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
Group A: Standard of care	The City of Hope QOL Survey for Ostomy Patients	* 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
Group B: Phone call	Pre-operative education (standard of care)	* 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
Group B: Phone call	Healthcare Utilization Form	* 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
Group B: Phone call	Patient Data Collection Form	* 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
Group B: Phone call	Phone call with CWOCN or PA	* 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
Group B: Phone call	The City of Hope QOL Survey for Ostomy Patients	* 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

Primary Outcome Measures

Name	Time	Method
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)
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)
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 Outcome Measures

Name	Time	Method
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)
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)
Impact that the early telephone follow-up and evaluation have on peristomal skin irritation DET score	30-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 scores of QOL (quality of life) questionnaire	30-day clinical visit (approximately 37-52 days after admission)
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)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States