- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00243334
Improving Safety and Quality With Outpatient Order Entry
Panoramica dello studio
Stato
Descrizione dettagliata
Quality gaps that are relevant to the ambulatory setting include a high incidence of adverse drug events and lack of compliance to established guidelines for preventive care, chronic disease management and test result follow-up. Clinical decision support systems (CDSS) and ambulatory computerized physician order entry (ACPOE) have been touted as powerful interventions to address these concerns. However, doubts exist about the efficacy of these systems in the ambulatory setting, especially when they exist in isolation. Also, despite the evidence of the impact of inpatient CPOE, the impact of ACPOE has not been well studied. Moreover, the adoption of CDSS and ACPOE systems is slow, and their value proposition remains uncertain.
Tightly integrating CDSS with ACPOE serves as a promising strategy to improve quality and efficiency in the ambulatory setting by facilitating physician action. When ACPOE is linked with CDSS, clinicians can be prompted at various points during their workflow about the desirable course of action and simultaneously be given the opportunity to execute the action (by ordering it) with minimal effort. We hypothesize that the value of ACPOE integrated with advanced CSDSS lies in improved medication safety and guideline compliance, but also improved efficiencies for the provider and the health-care system. We further hypothesize that the value added by these systems overall out weights their costs. This study will evaluate the impact of integrating ACPOE with advanced CDSS on important safety and quality domains in the ambulatory setting using randomized controlled trials. In addition, we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis.
There are 2 interventions periods. During Intervention Period 1, a randomized selection of clinics (Arm 1) will receive basic order entry without integrated decision support (i.e. no intervention) while another randomized selection of clinics (Arm 2) receive order entry integrated with decision support in the form of delivery of reminders and alerts during a clinical encounter (Intervention A). During Intervention Period 2, Arm 2 clinics will continue to receive Intervention A. However, Arm 1 clinics receive Intervention A plus additional decision support delivered in between clinic encounters (Intervention B).
Comparisons:
We will evaluate the impact of Intervention A (during visit) and intervention B (between visits) in 2 clustered randomized controlled trials, giving us accurate estimates of their individual efficacies. This is particularly important because these findings will highlight the relative value of these 2 different modes of decision support and inform organizations and vendors about how to invest their development resources. We also will be able to evaluate the combined impact of interventions A and B (between visits) by comparing the outcome in Arm 2 across the 2 intervention periods while simultaneously controlling for any secular trends (as observed in Arm 1 across the 2 intervention periods). All clinics, regardless of randomization status, will have access to at least one intervention during study period.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Massachusetts
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Boston, Massachusetts, Stati Uniti, 02481
- Partners HealthCare System, Inc.
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All physicians in on-site and satellite adult outpatient clinics with the Brigham and Women's Hospital and Massachusetts General Hospital
Exclusion Criteria:
- Study clinics must have adopted our electronic health record system, the Longitudinal Medical Record, for at least 24 months and must have implemented the basic version of the internally-developed lab order entry module.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
Decision Support integrated with Order Entry
|
Actiobable Reminders related to medication monitoring, preventive care and chronic disease management, and test result follow-up are administered either during the visit or between visits.
|
Nessun intervento: 2
Decision Support Only (not integrated with order entry)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Whether an instance that requires ordering of an appropriate laboratory test or medication or other appropriate monitoring action (based on guidelines and electronic clinical data) is associated with appr opriate action.
Lasso di tempo: Within 14 days of a patient visit or 28 days of the arrival of a test result
|
Within 14 days of a patient visit or 28 days of the arrival of a test result
|
Whether the incidence of a particular abnormal result (based on guidelines and electronic clinical data) was associated with the appropriate follow-up.
Lasso di tempo: Varies by major test type
|
Varies by major test type
|
Whether a test ordered does not get performed.
Lasso di tempo: Varies by major test type
|
Varies by major test type
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
The time to appropriate action following the firing of a reminder.
Lasso di tempo: Within 14 days of the reminder firing
|
Within 14 days of the reminder firing
|
The time to appropriate monitoring action following the arrival of the index lab result.
Lasso di tempo: Within 28 days of lab result
|
Within 28 days of lab result
|
The time to appropriate follow-up following a particular abnormal result.
Lasso di tempo: Within 28 days of the result
|
Within 28 days of the result
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Tejal K Gandhi, MD, MPH, Brigham and Women's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 5R01HS015226-02 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .