- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03245879
Antibiotic Stewardship in Small Hospitals (SCORE)
2017. augusztus 7. frissítette: Eddie Stenehjem, Intermountain Health Care, Inc.
Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention
Core elements of effective antibiotic stewardship programs (ASPs) have been identified and evidence-based guidelines have been developed for implementation.
The majority of the evidence used for these guidelines are from published studies on the effectiveness of ASPs in large academic or large community hospitals.
A significant portion of healthcare in the United States, however, takes place in small hospitals.
In 2015, 73% of US hospitals had < 200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days.
Limited studies on the effectiveness of antibiotic stewardship implementation have been performed in hospitals with < 200 beds.
Antibiotic use rates and selection patterns in these small hospitals are similar to that of large hospitals and the majority of small hospitals lack formal ASP that meet the CDC's core elements.
The objective of this real-world implementation study was to assess the effectiveness of three ASP strategies of escalating intensity designed specifically for small hospitals within a vertically integrated healthcare delivery system.
A tanulmány áttekintése
Állapot
Befejezve
Beavatkozás / kezelés
Részletes leírás
The investigators designed a clustered randomized controlled intervention to evaluate 3 antibiotic stewardship strategies designed for small hospitals.
Each hospital was randomized to one of three ASP interventions with increasing levels of intensity and intervention (Programs 1, 2, 3).
The investigators felt that clinical equipoise about the effect of ASPs did not exist and randomizing to a no-intervention group was unacceptable.
Antibiotic use was compared within each group before and after the intervention.
In keeping with other real-world implementation studies, secondary analyses were planned to include an interrupted time series design to evaluate the impact of each strategy.
Randomization of hospitals was stratified based on patient volume.
Hospital administration and clinical leadership were not blinded to which ASP program they were randomly assigned to, but there were no public announcements.
The intervention started March 2014 and ended June 2015.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
30000
Fázis
- Nem alkalmazható
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Intermountain Healthcare acute care hospital with < 200 licensed beds
- No formal antibiotic stewardship program in place
Exclusion Criteria:
-All Intermountain Healthcare specialty hospitals, regardless of bed size
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Aktív összehasonlító: Program 1
Implementation of a basic antibiotic stewardship program focusing on education, access to Infectious Diseases physicians, and availability of antibiotic use data.
|
Program 1 hospitals received a basic curriculum and tools for implementation of basic antibiotic stewardship interventions.
Hospitals required an indication for every antibiotic order.
A daily email was sent to a designated email account when a patient had been on an antibiotic for >48 hours.
Curriculum included implementing antibiotic time-outs, IV to PO conversion, indications, evaluating for bug-drug mismatches, and recommendations on when to call the Infectious Diseases (ID) hotline.
A daily antibiotic stewardship check list was created.
All materials were provided to all pharmacists and remained on-site.
Clinicians had access to an ID telephone hotline to answer clinical questions.
Pharmacy directors and hospital leadership were provided a monthly, hospital-specific, antibiotic use dashboard.
All pharmacy directors and staff received a monthly newsletter.
|
Aktív összehasonlító: Program 2
This arm increases antibiotic stewardship education and interventions.
Program 2 hospitals performed audit and feedback of pre-specified antibiotics and implemented locally controlled restrictions.
|
Program 2 hospitals received all the interventions of Program 1.
In addition, Program 2 hospitals received more intense antibiotic stewardship education.
Educational topics included audit and feedback, antibiotic de-escalation, the need for antibiotics targeting anaerobic bacteria, antibiotic allergy verification, and antibiotic restrictions.
Pharmacists in Program 2 hospitals reviewed patients on vancomycin, piperacillin/tazobactam, imipenem, meropenem, and cefepime.
For patients receiving one of these antibiotics, pharmacists reviewed the patients' microbiology data to identify opportunities for antibiotic de-escalation, IV to PO conversion, bug-drug mismatches, and/or indications for calling the ID hotline.
Program 2 hospitals also restricted daptomycin, linezolid, imipenem, meropenem, ceftaroline, tigecycline, and all mold active antifungals.
In Program 2 hospitals, the local pharmacy staff pre-authorized restricted antibiotics based on defined criteria.
|
Aktív összehasonlító: Program 3
This arm was the most intensive antibiotic stewardship intervention.
It included signficant audit and feedback, ID controlled restrictions, and ID review of designated culture/lab results.
|
Program 3 hospitals received all the interventions of Program 1 and Program 2. In addition, pharmacists in program 3 hospitals reviewed an expanded list of antibiotics for audit and feedback.
These antibiotics included: Vancomycin, piperacillin/tazobactam, imipenem, meropenem, cefepime, ertapenem, aminoglycosides, ceftriaxone, and fluoroquinolones.
Program 3 hospitals implemented the same antibiotic restrictions as Program 2 but ID pharmacists controlled pre-authorization of restricted antibiotics.
In addition, an ID physician reviewed pre-specified positive cultures (e.g.
all positive blood cultures, cultures with highly resistant Enterobacteraciae) and contacted providers with recommendations as needed.
ID physician review occurred Monday through Friday and alerts were batched daily at 6am.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Total antibiotic use
Időkeret: Total antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in total antibiotic use between the baseline and intervention periods while accounting for the cluster randomized design.
|
Total antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Broad spectrum antibiotic use
Időkeret: Broad spectrum antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the broad spectrum antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in broad spectrum antibiotic use between the baseline and intervention periods
|
Broad spectrum antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the broad spectrum antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Restricted antibiotic use
Időkeret: Restricted antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the restricted antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in restricted antibiotic use between the baseline and intervention periods
|
Restricted antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the restricted antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
30-day readmission
Időkeret: 30-day readmission rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day readmission rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in 30 day readmission rates between the baseline and intervention periods
|
30-day readmission rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day readmission rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
30-day mortality
Időkeret: 30-day mortality rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day mortality rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in 30 day mortality rates between the baseline and intervention periods
|
30-day mortality rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day mortality rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Hospital length of stay
Időkeret: Average hospital length of stay during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the average hospital length of stay during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in hospital length of stay between the baseline and intervention periods
|
Average hospital length of stay during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the average hospital length of stay during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Clostridium difficile
Időkeret: C. difficile rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the C. difficile rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in Clostridium difficile incidence between the baseline and intervention periods
|
C. difficile rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the C. difficile rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Stenehjem E, Hersh AL, Sheng X, Jones P, Buckel WR, Lloyd JF, Howe S, Evans RS, Greene T, Pavia AT. Antibiotic Use in Small Community Hospitals. Clin Infect Dis. 2016 Nov 15;63(10):1273-1280. doi: 10.1093/cid/ciw588. Epub 2016 Sep 30.
- Stenehjem E, Hersh AL, Buckel WR, Jones P, Sheng X, Evans RS, Burke JP, Lopansri BK, Srivastava R, Greene T, Pavia AT. Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Intervention. Clin Infect Dis. 2018 Aug 1;67(4):525-532. doi: 10.1093/cid/ciy155.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2013. július 1.
Elsődleges befejezés (Tényleges)
2015. június 1.
A tanulmány befejezése (Tényleges)
2015. június 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2017. augusztus 3.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2017. augusztus 7.
Első közzététel (Tényleges)
2017. augusztus 10.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. augusztus 10.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. augusztus 7.
Utolsó ellenőrzés
2017. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 1024823
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Nem
IPD terv leírása
N/A.
No individual patient level data available.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
az Egyesült Államokban gyártott és onnan exportált termék
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Program 1
-
Astellas Pharma IncBefejezveRheumatoid arthritisJapán
-
HK inno.N CorporationMég nincs toborzásEgészségesKoreai Köztársaság
-
University of NebraskaGenzyme, a Sanofi CompanyIsmeretlenMájátültetés | Májbetegség | ImmunszuppresszióEgyesült Államok
-
Imperial College Healthcare NHS TrustBefejezveGlomerulonephritis, membránosEgyesült Királyság
-
Astellas Pharma IncAstellas Pharma China, Inc.Megszűnt
-
University of Sao Paulo General HospitalBefejezve
-
Orasis Pharmaceuticals Ltd.BefejezveTávollátásEgyesült Államok
-
University of ThessalyBefejezve
-
Chulalongkorn UniversityBefejezveAllergiás náthaThaiföld
-
University of Sao Paulo General HospitalBefejezveTúlműködő hólyag szindrómaBrazília