- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Taipei, Taiwan, 110
- Taipei Medical University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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 navn:
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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.
|
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 navn:
|
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Ingen inngripen: Control Arm
The physicians assigned to this arm will not use and any computerized reminder.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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
|
Physicains who participated in this trial will be followed for an expected average of 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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.
|
Physicains who participated in this trial will be followed for an expected average of 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yu-Chuan Li, Taipei Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NSC100-2320-B-038-034
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