- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan, 110
- Taipei Medical University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
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 |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Aktiv 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.
Andre navne:
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Ingen indgriben: Control Arm
The physicians assigned to this arm will not use and any computerized reminder.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The percentage of contrast-enhanced imaging(CEI) orders with high CIN risk
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The order elimination rate of high CIN risk orders attributed to the computerized reminder
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yu-Chuan Li, Taipei Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NSC100-2320-B-038-034
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