- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01385982
Improving Management of Outpatient Actionable Test Results (OutptATR)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Partners HealthCare
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Primary care physicians will be enrolled in the study by virtue of being an actively practicing clinician in an PHS ambulatory practice, and having at least one patient with a diagnostic test included in the PHS CCSTR intervention. The patient population will consist of adult patients >17 years of age with diagnostic tests in the affiliated ambulatory practices of PHS. Patients will be recruited into the study by a review of electronic medical record data to identify patients with a diagnostic test specified in the PHS CCSTR intervention.
Exclusion Criteria:
Participants who do not meet the inclusion/eligibility requirements will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Actionable Test Results
Creating standardized policies and procedures around actionable test results (ATR) management, and implementing them network-wide:
|
The intervention includes enterprise-wide standardization of actionable test result (ATR) definitions with stratification of significant results into alert levels, expected timeframes for clinician responses, a set of policies for ATR follow-up, metrics to measure ATR management and performance feedback.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Acknowledged Sub-Critical/Abnormal ATRs
Tidsramme: Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert
|
The primary outcome of interest is the proportion of sub-critical/abnormal (Level 3 Laboratory and Level 2 Cardiology) ATRs documented as acknowledged by the responsible clinician and having appropriate, follow-up action(s).
|
Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diagnosis and/or Treatment Delays
Tidsramme: Minumum of 3 months post ATR
|
The frequency of delays to diagnoses and/or treatment of conditions of interest
|
Minumum of 3 months post ATR
|
Undiagnosed/Untreated Condition Frequency and Severity
Tidsramme: Minumum of 3 months post ATR
|
The frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.
|
Minumum of 3 months post ATR
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jeffrey Rothschild, M.D., Brigham and Women's Hospital
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
Andre undersøgelses-id-numre
- 2011P000035
- 1R18HS019603-01 (U.S.A. AHRQ bevilling/kontrakt)
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Kliniske forsøg med Actionable Test Result Management/Standardization
-
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-
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-
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