Reducing Readmissions in High-Risk Ostomates

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.

Study Overview

• Status: Terminated
• Conditions: Ileostomy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 physicianTurn in Patient Data Collection FormTurn in Healthcare Utilization FormComplete The City of Hope QOL Survey for Ostomy PatientsOstomy assessment with a CWOCN, including photo of ostomy site	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; -Form that contains date, area to record number of pouches, and if home health care visit took place.; 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; 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.
Experimental: 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 physicianTurn in Patient Data Collection FormTurn in Healthcare Utilization FormComplete The City of Hope QOL Survey for Ostomy PatientsOstomy assessment with a CWOCN, including photo of ostomy site	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; -Form that contains date, area to record number of pouches, and if home health care visit took place.; 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; 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.; Other: Phone call with CWOCN or PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 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

Outcome Measure	Measure Description	Time Frame
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 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 durable medical equipment (DME) usage		30-day CWOCN visit (approximately 37-52 days after admission)
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)
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Steven R Hunt, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201601014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No