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Improving Safety and Quality With Outpatient Order Entry

14 februari 2013 bijgewerkt door: Tejal Gandhi, Brigham and Women's Hospital
The purpose of this study is to evaluate the impact of integrating ambulatory computerized physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety and quality domains in the ambulatory setting, including: a) medication monitoring, b) preventive care and chronic disease management, and c) test result follow-up. In addition we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis. 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

800

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02481
        • Partners HealthCare System, Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geen tussenkomst: 2
Decision Support Only (not integrated with order entry)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: 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.
Tijdsspanne: Varies by major test type
Varies by major test type
Whether a test ordered does not get performed.
Tijdsspanne: Varies by major test type
Varies by major test type

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The time to appropriate action following the firing of a reminder.
Tijdsspanne: 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.
Tijdsspanne: Within 28 days of lab result
Within 28 days of lab result
The time to appropriate follow-up following a particular abnormal result.
Tijdsspanne: Within 28 days of the result
Within 28 days of the result

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Tejal K Gandhi, MD, MPH, Brigham and Women's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2007

Primaire voltooiing (Werkelijk)

1 december 2009

Studie voltooiing (Verwacht)

1 juni 2013

Studieregistratiedata

Eerst ingediend

21 oktober 2005

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2005

Eerst geplaatst (Schatting)

24 oktober 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

18 februari 2013

Laatste update ingediend die voldeed aan QC-criteria

14 februari 2013

Laatst geverifieerd

1 februari 2013

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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