- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01778140
Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System
Randomized Controlled Trial: Comparing Effects of Patient-Specific Versus Non-Patient-Specific Computerized Reminder System to Reduce Contrast-Induced Nephropathy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
We hypothesize that a clinical decision support system (CDSS) designed with "Patient-specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy.
A 3-arm randomized controlled trial (RCT) will be performed by cluster randomization using physicians as the unit of allocation. Physicians in 3 university medical centers will be randomly assigned into 1) patient-specific arm with Anti Contrast-Induced-Nephropathy(Anti-CIN) reminder, 2) non-patient-specific reminder arm, and 3) the control arm without any reminders, respectively.
The patient-specific alert, Anti-CIN system, is designed as a real-time CDSS implementation on CPOE for monitoring physician's contrast-enhanced CT and IVP orders. Computerized pop-up reminders provide the patient-specific encounters with optimal decision options when patients are at a high CIN risk or patients with unknown risk factors are encountered. Non-patient-specific reminders always pop up no matter whether the patient is at a high risk or not.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Taipei, Taiwan, 110
- Taipei Medical University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial.
Exclusion Criteria:
- The physician who never orders a CT scan or IVU study will be excluded
- The physician who never operates the CPOE by himself or herself will be excluded
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Patient-specific reminder
Intervention: Patient-specific computerized reminder.
The physicians assigned to this arm will use the patient-specific CDSS on CPOE.
The patient-specific reminder is designed as a real-time CDSS implemented on CPOE to monitor physician's contrast-enhanced image study orders.
Computerized pop-up reminders provide the patient-specific CIN risk profile and optimal decision options which are generated when patients with high risk or with unknown risk of CIN are encountered.
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The intervention targets are physicians,not patients.
This CDSS alerts physicians only when the patient with high risk of contrast-induced-nephropathy(CIN) is encountered.
On the contrast, the CDSS will not alert when the patient without CIN risk is encountered.
Andere Namen:
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Aktiver Komparator: Non-patient-specific reminder
Intervention: Non-patient-specific Computerized reminder.
The physicians assigned to this arm will use the Non-patient-specific reminders through CPOE.
Non-patient-specific reminders always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.
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The non-patient-specific computerized reminder always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.
Andere Namen:
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Kein Eingriff: Control Arm
The physicians assigned to this arm will not use and any computerized reminder.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The percentage of contrast-enhanced imaging(CEI) orders with high CIN risk
Zeitfenster: Physicains who participated in this trial will be followed for an expected average of 12 months
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The number of CEI ordered for patients at high CIN risk, divided by the total number of CEI orders.
[CEI]: contrast-enhanced image studies,such as CT or IVU.
[CIN]: contrast-induced nephropathy
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Physicains who participated in this trial will be followed for an expected average of 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The order elimination rate of high CIN risk orders attributed to the computerized reminder
Zeitfenster: Physicains who participated in this trial will be followed for an expected average of 12 months
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The number of CEI orders with high CIN risk cancelled by the physician attributed to our computerized reminder, divided by the total number of CEI orders with high CIN risk.
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Physicains who participated in this trial will be followed for an expected average of 12 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Yu-Chuan Li, Taipei Medical University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NSC100-2320-B-038-034
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