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Improving Quality of Care - Managing Atrial Fibrillation Through Care Teams and Health Information Technology (IQ-MATCH)

15 januari 2019 bijgewerkt door: Shirley Vichy Wang, Brigham and Women's Hospital

This stepped wedge randomized intervention will apply machine learning algorithms in an electronic health record system to identify primary care patients with non-valvular atrial fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An Anticoagulant Management Service (AMS) will offer support to primary care providers regarding treatment for relevant patients (either warfarin and novel oral anticoagulants).

This study seeks to:

  1. increase the proportion of appropriately anticoagulated patients with AF,
  2. understand the reasons for lack of anticoagulation, and
  3. document the proportion of patients with AF who are appropriately not anticoagulated (e.g. patient refusal, contraindication).

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with significant mortality and morbidity from stroke, thromboembolism, and related cardiovascular conditions. While the risk of stroke for AF patients as a whole tends to be greater than the general population; within the AF patient population, the risk of stroke is modified by the presence or absence of additional risk factors such as age, comorbid conditions, and prior stroke history.

There is a wealth of evidence for the effectiveness of anticoagulation therapy to prevent stroke and thromboembolism, but while anticoagulants have been demonstrated to be highly effective at preventing stroke and embolic events among AF patients, they are also known to increase the risk of major bleeding events. Anticoagulation with warfarin and other VKA drugs can be complex to manage. These drugs have narrow therapeutic windows and require close monitoring to stay within the target international normalized ratio (INR). They also have many known food and drug interactions.

In the last few years, several novel oral anticoagulants (NOAC) such as dabigatran, rivaroxaban, and apixaban have entered the market. While each of the NOACs demonstrated non-inferiority to warfarin in a large randomized clinical trial prior to FDA approval, experience with NOACs is limited in practice.

Our intervention will combine the ability of health information technology to filter large volumes of data with human capacity to understand subtleties and barriers for complex clinical decision making. Our intervention will facilitate a connection between patients, treating clinicians, and an established Anticoagulant Management Service (AMS) for coordinated care. We will use information from the EHR to direct additional efforts and resources toward reaching potentially unrecognized or undertreated atrial fibrillation patients with the greatest need for preventive anticoagulation therapy and lowest risk of adverse effects. This electronic safety net will assist with efficient allocation of scarce resources beyond usual care. The proposed clinical decision support/care-coordination process will be designed to address many of these identified barriers to appropriate anticoagulation therapy among AF patients. Here we define "appropriate" anticoagulation as a guideline informed shared decision between individual patients and their care team.

This intervention utilizes a stepped wedge design involving 14 primary care clinics affiliated with the Brigham and Women's Hospital. The timing of clinic entry to the intervention arm will be randomized.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

432

Fase

  • Niet toepasbaar

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:

  • Non-valvular atrial fibrillation as identified by machine learning algorithms
  • Primary care provider within Brigham and Women's Hospital
  • No evidence of a prescription for an anticoagulant in medical record for at least 1 year

Exclusion Criteria:

-

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: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention
Primary care providers in the intervention arm will receive lists of their patients with AF who are identified as being at high risk of stroke but not currently on anticoagulation therapy. Along with this list, which includes information on risks and benefits of anticoagulation, primary care providers will receive an offer of assistance from a respected Anticoagulation Management Service within the hospital network to help manage anticoagulation for referred patients.
The intervention arm offers primary care providers additional information on patient risks and benefits as well as an offer of assistance with managing a patient's anticoagulation from a respected service at BWH.
Andere namen:
  • Antistollingsmiddel
Geen tussenkomst: Usual Care
Primary care providers will provide usual care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anticoagulation therapy
Tijdsspanne: randomization to 1 month post randomization
the proportion of eligible patients who initiate anticoagulation therapy following randomization to intervention or usual care
randomization to 1 month post randomization

Medewerkers en onderzoekers

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

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 (Werkelijk)

1 mei 2016

Primaire voltooiing (Werkelijk)

1 augustus 2017

Studie voltooiing (Werkelijk)

1 augustus 2017

Studieregistratiedata

Eerst ingediend

6 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2016

Eerst geplaatst (Schatting)

12 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 januari 2019

Laatste update ingediend die voldeed aan QC-criteria

15 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to share individual participant data outside of the staff and participants themselves.

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 .

Klinische onderzoeken op Intervention

Abonneren