Reducing Readmissions in High-Risk Ostomates

NCT ID: NCT02658123

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-08-22

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.

Conditions

Ileostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group A: 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 Type: ACTIVE_COMPARATOR

Pre-operative education (standard of care)

Intervention Type: OTHER

Home health care visits (standard of care)

Intervention Type: OTHER

Follow-up post-operative visits

Intervention Type: OTHER

Patient Data Collection Form

Intervention Type: OTHER

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

Healthcare Utilization Form

Intervention Type: OTHER

• 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

Intervention Type: OTHER

• 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.

Group B: Phone call

• 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 Type: EXPERIMENTAL

Pre-operative education (standard of care)

Intervention Type: OTHER

Home health care visits (standard of care)

Intervention Type: OTHER

Follow-up post-operative visits

Intervention Type: OTHER

Patient Data Collection Form

Intervention Type: OTHER

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

Healthcare Utilization Form

Intervention Type: OTHER

• 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

Intervention Type: OTHER

• 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

Intervention Type: OTHER

Interventions

Pre-operative education (standard of care)

Intervention Type: OTHER

Home health care visits (standard of care)

Intervention Type: OTHER

Follow-up post-operative visits

Intervention Type: OTHER

Patient Data Collection Form

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Phone call with CWOCN or PA

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Hunt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201601014

Identifier Type: -

Identifier Source: org_study_id