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

27 december 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: compliance surveillance and improvement strategy
External monitor to ensure compliance with an educational protocol.
Inget ingripande: Usual Care
educational session at the start of the study

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Readmission to the hospital
Tidsram: 30 days after hospital discharge
30 days after hospital discharge

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient satisfaction
Tidsram: 3-6 months after surgery
S-CAHPS
3-6 months after surgery
Index length-of-stay
Tidsram: Index length-of-stay
Time from surgical date to hospital discharge
Index length-of-stay
Emergency room visit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Minnesota

Samarbetspartners

Colon and Rectal Surgery Associates, Ltd.

Utredare

  • Huvudutredare: Mary R Kwaan, MD, University of Minnesota

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2014

Primärt slutförande (Faktisk)

1 juni 2016

Avslutad studie (Faktisk)

11 november 2016

Studieregistreringsdatum

Först inskickad

3 september 2015

Först inskickad som uppfyllde QC-kriterierna

3 september 2015

Första postat (Uppskatta)

7 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 december 2017

Senast verifierad

1 december 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 1408M52923

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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