- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00766207
Electronic Notification of Teratogenic Risks (PREVENT)
Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).
Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Delmont, Pennsylvania, Forenede Stater, 15626
- Partners In Health
-
Level Green, Pennsylvania, Forenede Stater, 15085
- Partners In Health
-
Murrysville, Pennsylvania, Forenede Stater, 15085
- Partners In Health
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- General Internal Medicine Oakland (GIMO) Practice
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women aged 18-45 seen at a participating primary care clinic
Exclusion Criteria:
- Non-English speakers
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: multi-faceted decision support
Multi-faceted decision support
|
multi-faceted decision support
|
|
Aktiv komparator: control
stream-lined clinical alert
|
electronic notification that a medication is potentially teratogenic
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eleanor B Schwarz, MD, MS, University of Pittsburgh
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
- R18HS017093-01 (U.S.A. AHRQ bevilling/kontrakt)
- 1R18HS017093-01 (U.S.A. AHRQ bevilling/kontrakt)
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