Reducing Readmissions in High-Risk Ostomates

NCT02658123 | Terminated

• 1 other identifier: 201601014
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

  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)

Study Arms (2)

Group A: Standard of care

ACTIVE COMPARATOR

* 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; Other: Healthcare Utilization Form; Other: The City of Hope QOL Survey for Ostomy Patients

Group B: Phone call

EXPERIMENTAL

* 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; Other: Healthcare Utilization Form; Other: The City of Hope QOL Survey for Ostomy Patients; Other: Phone call with CWOCN or PA

Interventions

Pre-operative education (standard of care) OTHER

Group A: Standard of care; Group B: Phone call

Home health care visits (standard of care) OTHER

Group A: Standard of care; Group B: Phone call

Follow-up post-operative visits OTHER

Group A: Standard of care; Group B: Phone call

Patient Data Collection Form OTHER

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

Group A: Standard of care; Group B: Phone call

Healthcare Utilization Form 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

Group A: Standard of care; Group B: Phone call

The City of Hope QOL Survey for Ostomy Patients 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 A: Standard of care; Group B: Phone call

Phone call with CWOCN or PA OTHER

Group B: Phone call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to receive home health care.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Steven R Hunt, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: April 1, 2016
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)