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System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program (SWIFT)

27. december 2017 opdateret af: University of Minnesota
Short-term post-operative complications after colon and rectal surgery present a known major clinical and financial burden for patients and hospitals. Focused efforts to reduce readmissions after colorectal surgery is one potentially high-yield and broad approach to address this problem since post- operative complications are the strongest predictor of readmissions. We focus on decreasing readmissions after ileostomy surgery by using a previously published intervention that prevents dehydration in the outpatient setting and decreases acute renal failure complications. We plan to introduce the SWIFT post op program for ileostomy patients at one academic and two community hospitals which are part of a single health care system, and to then randomize patients to usual care in the setting of this new program versus an aggressive compliance surveillance and improvement strategy (CSIS) strategy using study personnel. Our primary study outcome is all-cause 30-day readmission, and our secondary outcomes include patient satisfaction (CAHPS scores) and a cost-benefit analysis. We seek to create a partnership between colorectal surgeons, inpatient nurse managers and wound ostomy continence nurses (WOCN) at the three sites, linking them with outpatient nurse practitioners and physician's assistants at the respective colorectal surgery clinics who facilitate care-transition after hospital discharge.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:

Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.

The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.

  • Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
  • A self-assessment tool for patients and families to confirm understanding of the education materials.
  • Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
  • Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.

The usual care arm will include no such surveillance.

The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

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
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota Medical Center -Fairview
      • Saint Paul, Minnesota, Forenede Stater, 55114
        • Colon and Rectal Surgery Associates

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:

  • Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
  • patients who have had an ileostomy in the past are eligible
  • patients who have an ileostomy to address a recent surgical complication are eligible

Exclusion Criteria:

  • Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
  • patients on dialysis
  • patients who require chronic TPN, IVF, or have short gut
  • non-English speaking patients who do not have easy access to an appropriate interpreter.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: compliance surveillance
  • Prospective audits by study personnel
  • Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to administer a screening questionnaire to identify patients at risk of dehydration. Study personnel will ensure this phone call is made.
Adfærdsmæssigt: compliance surveillance and improvement strategy
External monitor to ensure compliance with an educational protocol.
Ingen indgriben: Usual Care
educational session at the start of the study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Readmission to the hospital
Tidsramme: 30 days after hospital discharge
30 days after hospital discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction
Tidsramme: 3-6 months after surgery
S-CAHPS
3-6 months after surgery
Index length-of-stay
Tidsramme: Index length-of-stay
Time from surgical date to hospital discharge
Index length-of-stay
Emergency room visit
Tidsramme: 30 days after hospital discharge
Emergency room visits for any reason 30 days after surgery
30 days after hospital discharge
Total hospital-length-of-stay
Tidsramme: 30 days after hospital discharge
Total hospital length of stay for any reason after surgery
30 days after hospital discharge
Readmission due to dehydration or acute renal failure
Tidsramme: 30 days after hospital discharge
Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria
30 days after hospital discharge
Post-discharge follow up phone call
Tidsramme: 30 days after hospital discharge
Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
30 days after hospital discharge

Samarbejdspartnere og efterforskere

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

Sponsor

University of Minnesota

Samarbejdspartnere

Colon and Rectal Surgery Associates, Ltd.

Efterforskere

  • Ledende efterforsker: Mary R Kwaan, MD, University of Minnesota

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. oktober 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

11. november 2016

Datoer for studieregistrering

Først indsendt

3. september 2015

Først indsendt, der opfyldte QC-kriterier

3. september 2015

Først opslået (Skøn)

7. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1408M52923

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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