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Reducing Readmissions in High-Risk Ostomates

27. september 2018 opdateret af: Washington University School of Medicine
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

94

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andet: Pre-operative education (standard of care)
Andet: Home health care visits (standard of care)
Andet: Follow-up post-operative visits
Andet: Patient Data Collection Form
-Form that contains date, area to record number of pouches, and if home health care visit took place.
Andet: 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
Andet: 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.
Eksperimentel: 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
Andet: Pre-operative education (standard of care)
Andet: Home health care visits (standard of care)
Andet: Follow-up post-operative visits
Andet: Patient Data Collection Form
-Form that contains date, area to record number of pouches, and if home health care visit took place.
Andet: 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
Andet: 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.
Andet: Phone call with CWOCN or PA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Within the first 30 days after hospital charge (up to approximately 37 days)
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
Tidsramme: Within the first 30 days after hospital charge (up to approximately 37 days)
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
Tidsramme: Within the first 30 days after hospital charge (up to approximately 37 days)
Within the first 30 days after hospital charge (up to approximately 37 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impact that the early telephone follow-up and evaluation have on the number of office visits
Tidsramme: First 30 days after hospital discharge (approximately 37-52 days after admission)
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
Tidsramme: First 30 days after hospital discharge (approximately 37-52 days after admission)
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
Tidsramme: 30-day CWOCN visit (approximately 37-52 days after admission)
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
Tidsramme: 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
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
Tidsramme: 30-day clinical visit (approximately 37-52 days after admission)
30-day clinical visit (approximately 37-52 days after admission)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Efterforskere

  • Ledende efterforsker: Steven R Hunt, M.D., Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2016

Primær færdiggørelse (Faktiske)

22. august 2018

Studieafslutning (Faktiske)

22. august 2018

Datoer for studieregistrering

Først indsendt

14. januar 2016

Først indsendt, der opfyldte QC-kriterier

14. januar 2016

Først opslået (Skøn)

18. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 201601014

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