Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01927445
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
The objective of this project is to increase the proportion of patients with AF that receive adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are permanently disabled. Yet there remains a large portion of patients who do not receive appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of quality improvement strategies in primary care could increase the proportion of patients with atrial fibrillation appropriately treated with stroke prevention therapy. The investigators' goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day practice in primary care and can be readily and broadly disseminated if successful.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: quality improvement toolkit Not Applicable

Detailed Description:
The prevalence of atrial fibrillation (AF) is growing as the population ages and 15% of all strokes are already attributed to AF. Unfortunately, half of patients with AF do not receive prescriptions for anticoagulation to prevent stroke due to a variety of system, provider, and patient-level barriers. The investigators will conduct a pragmatic, cluster-randomized controlled trial to test a 'toolkit' of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously facilitate proactive care by providers and activate patients, the toolkit includes provider- focused strategies (education, audit and feedback, electronic medical record-based tools including decision support and reminders) plus patient-directed strategies (educational letters and reminders). Thirty three primary care clinics will be randomized to the intervention or usual care. The trial will last 12 months and will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-concordant care for stroke prevention. Analysis will be blind to allocation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care: Protocol for a Pragmatic, Cluster-randomized Trial
Study Start Date : August 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care
No standardized intervention for management of patients with atrial fibrillation. Instead participants receive interventions for management of chronic kidney disease.
Experimental: quality improvement toolkit
The toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support and reminders) plus patient-directed strategies (educational letters and reminders).
Other: quality improvement toolkit
educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback




Primary Outcome Measures :
  1. Proportion of patients with AF receiving guideline-concordant stroke prevention therapy [ Time Frame: one year ]
    Patients with risk factors for stroke (ie. CHADS2 >1 or age >65) who are prescribed anticoagulants and patients with no risk factors for stroke (ie. CHADS2 = 0 and age <65) who are not prescribed anticoagulants will be considered to be receiving guideline concordant therapy. (For patients with CHADS2 = 1 but aged < 65 the guideline recommendations are unclear, so these patients will not be considered in the primary analysis. For example, in patients with AF and hypertension at a younger age, anticoagulation or aspirin or no treatment would each be reasonable.)


Secondary Outcome Measures :
  1. proportion of patients taking warfarin in therapeutic range [ Time Frame: one year ]
    patients must have INR measured 8 times during the year and therapeutic range assessed using Rosendaal method

  2. proportion of patients taking a novel anticoagulant with appropriate dosing [ Time Frame: one year ]
    Dabigatran, rivaroxaban and apixaban should be dose-adjusted in renal failure and avoided if estimated creatinine clearance is <30. Lower dose dabigatran is recommended for patients over 80.

  3. proportion receiving aspirin [ Time Frame: one year ]
  4. proportion receiving clopidogrel [ Time Frame: one year ]
  5. proportion achieving target blood pressure [ Time Frame: one year ]
    target defined as <130/80 for patients with diabetes, <150/80 for patients over 80, and <140/90 for all others



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physicians are participants in the Electronic Medical Record Administrative-data Linked Database (EMRALD).
  • Patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation

Exclusion Criteria:

  • Physicians who do not consent to data sharing
  • Patients who change physicians during the course of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927445


Locations
Layout table for location information
Canada, Ontario
Institute for Clinical Evaluative Sciences
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Investigators
Layout table for investigator information
Principal Investigator: Karen Tu, MD ICES

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01927445     History of Changes
Other Study ID Numbers: G-13-0001873
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes