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Reducing Readmissions in High-Risk Ostomates

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ClinicalTrials.gov Identifier: NCT02658123
Recruitment Status : Terminated (Decline in enrollment, lack of efficacy, and completion of funding accrual)
First Posted : January 18, 2016
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Reducing Readmissions in High-Risk Ostomates
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Ileostomy
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
94
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
300
Actual Study Completion Date  ICMJE August 22, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658123
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven R Hunt, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP