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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

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.

Condition or disease Intervention/treatment Phase
Ileostomy 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Readmissions in High-Risk Ostomates
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


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 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
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 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
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



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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

  5. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658123


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Steven R Hunt, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02658123    
Other Study ID Numbers: 201601014
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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