Reducing Readmissions in High-Risk Ostomates

• ClinicalTrials.gov Identifier: NCT02658123
• Recruitment Status: Terminated
• First Posted: January 18, 2016
• Last Update Posted: October 1, 2018
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Tracking Information

• First Submitted Date: January 14, 2016
• First Posted Date: January 18, 2016
• Last Update Posted Date: October 1, 2018
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: August 22, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2016)

• 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within the first 30 days after hospital charge (up to approximately 37 days) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 1, 2017)

• Impact that the early telephone follow-up and evaluation have on the number of office visits [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30-day clinical visit (approximately 37-52 days after admission) ]

Original Secondary Outcome Measures (submitted: January 14, 2016)

• Impact that the early telephone follow-up and CWOCN evaluation have on the number of office CWOCN visits [ Time Frame: First 30 days after hospital discharge (approximately 37-52 days after admission) ]
• impact that the early telephone follow-up and CWOCN evaluation have on the number of phone calls to office [ Time Frame: First 30 days after hospital discharge (approximately 37-52 days after admission) ]
• Impact that the early telephone follow-up and CWOCN evaluation have on peristomal skin irritation [ Time Frame: 30-day CWOCN visit (approximately 37-52 days after admission) ]
• Impact that the early telephone follow-up and CWOCN evaluation have on peristomal skin irritation DET score [ Time Frame: 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 CWOCN evaluation have on the scores of QOL (quality of life) questionnaire [ Time Frame: 30-day standard clinical visit (approximately 37-52 days after admission) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reducing Readmissions in High-Risk Ostomates
• Official Title: Reducing Readmissions in High-Risk Ostomates
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Ileostomy

Intervention

• 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

Study Arms

• 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 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
  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
• 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 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
  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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 5, 2018): 94
• Original Estimated Enrollment (submitted: January 14, 2016): 300
• Actual Study Completion Date: August 22, 2018
• Actual Primary Completion Date: August 22, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02658123
• Other Study ID Numbers: 201601014
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Washington University School of Medicine
• Study Sponsor: Washington University School of Medicine
• Collaborators: Not Provided

Investigators

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

• PRS Account: Washington University School of Medicine
• Verification Date: September 2018