Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

NCT ID: NCT01927367

Last Updated: 2021-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-11-30

Brief Summary

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Research Question: Among community-based patients with AF, does providing an integrated Clinical Decision Support System (CDSS) to providers and patients improve process of care and clinical outcomes, and decrease the healthcare costs and resource utilization over 12 months, as compared to usual care?

Intervention: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines, to support primary care providers and patients in optimizing and standardizing AF care.

Detailed Description

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Atrial fibrillation (AF) is the most common abnormality of cardiac rhythm. It is also a disease of aging, affecting 3% of adults aged \> 45 years and 12% of those aged \> 75. Individually, AF's rapid and irregular heart beat is most frequently perceived as undesirable palpitations, but more threatening impacts are heart failure, catastrophic stroke and premature death. AF also markedly impairs quality of life.

Although patients with AF are at increased risk of stroke, death and hospitalization, many patients are not benefiting from evidence-informed, best-care strategies. Gaps have been documented in the knowledge, skills and competencies of primary care clinicians concerning the management of AF in Canada. For example, a large proportion of AF patients at moderate to high risk for stroke do not receive guideline recommended thromboprophylaxis; and of those that do, many are not optimally controlled. One Canadian study also found that in patient with known AF and a prior stroke, who were then admitted with a second stroke, 15% were not on any anticoagulation and only 18% were on warfarin and within the therapeutic range. Opportunities certainly exist to enhance the uptake of the Canadian AF Clinical Practice Guideline recommendations and best-care approaches in the primary care setting.

Patients need to be the focus of care services and be actively engaged and empowered to manage their care, with the support of health care providers. We believe that health system efficiency, care quality and patient safety can be enhanced through the use of innovative, integrated, interactive, pro-active and personalized point-of- care solutions targeting both providers and patients. This is the premise for the IMPACT-AF study.

Primary care providers and their patients are anticipated to benefit from enhanced use of health information technology regarding the management of patients with AF. A clinical guideline-based decision support system (CDSS) will be developed and tested in primary care settings across Nova Scotia.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clinical Decision Support System for AF

Providers randomized to use the Clinical Decision Support System (CDSS, a web-based tool).

Group Type OTHER

Clinical Decision Support System for AF

Intervention Type OTHER

A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.

Usual Care

Usual Care - providers are not eligible to access / use the CDSS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical Decision Support System for AF

A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.

Intervention Type OTHER

Other Intervention Names

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CDSS

Eligibility Criteria

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Inclusion Criteria

* Age \>/= 18 years (no max age limit)
* Confirmed atrial fibrillation.
* Able to provide informed consent in English.

Exclusion Criteria

* Patients unable to provide informed consent.
* Patients who are not expected to be alive at the end of the 12 month follow up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Population Health Research Institute

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Jafna L Cox

OTHER

Sponsor Role lead

Responsible Party

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Jafna L Cox

Staff Cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jafna L Cox, MD, FRCPC, FACC

Role: PRINCIPAL_INVESTIGATOR

CDHA

Syed Sibte Raza Abidi, MSc, PhD

Role: STUDY_DIRECTOR

Dalhousie University

Locations

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Capital District Health Authority

Halifax, Nova Scotia, Canada

Site Status

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Hamlin J, Cox J, Hamilton L, Nemis-White J, McKillop J, Sandila N, Parkash R. Regional Disparities in Atrial Fibrillation Management: An IMPACT-AF Substudy. CJC Open. 2024 Jul 3;6(10):1162-1169. doi: 10.1016/j.cjco.2024.06.010. eCollection 2024 Oct.

Reference Type DERIVED
PMID: 39525336 (View on PubMed)

Cox J, Hamilton L, Thabane L, Foster G, MacKillop J, Xie F, Ciaccia A, Choudhri S, Nemis-White J, Parkash R; IMPACT-AF Investigators. Computerized clinical decision support to improve stroke prevention therapy in primary care management of atrial fibrillation: a cluster randomized trial. Am Heart J. 2024 Jul;273:102-110. doi: 10.1016/j.ahj.2024.04.016. Epub 2024 Apr 28.

Reference Type DERIVED
PMID: 38685464 (View on PubMed)

Humphries B, Cox JL, Parkash R, Thabane L, Foster GA, MacKillop J, Nemis-White J, Hamilton L, Ciaccia A, Choudhri SH, Kovic B, Xie F. Resource use and cost associated with computerized decision support system and usual care in managing patients with atrial fibrillation: analysis of IMPACT-AF randomized trial data. BMC Med Inform Decis Mak. 2023 Oct 18;23(1):228. doi: 10.1186/s12911-023-02329-7.

Reference Type DERIVED
PMID: 37853351 (View on PubMed)

Nemis-White JM, Hamilton LM, Shaw S, MacKillop JH, Parkash R, Choudhri SH, Ciaccia A, Xie F, Thabane L, Cox JL; IMPACT-AF Investigators. Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care. Trials. 2021 Aug 11;22(1):531. doi: 10.1186/s13063-021-05488-y.

Reference Type DERIVED
PMID: 34380542 (View on PubMed)

Humphries B, Cox JL, Parkash R, Thabane L, Foster GA, MacKillop J, Nemis-White J, Hamilton L, Ciaccia A, Choudhri SH, Xie F; IMPACT-AF Investigators. Patient-Reported Outcomes and Patient-Reported Experience of Patients With Atrial Fibrillation in the IMPACT-AF Clinical Trial. J Am Heart Assoc. 2021 Aug 3;10(15):e019783. doi: 10.1161/JAHA.120.019783. Epub 2021 Jul 28.

Reference Type DERIVED
PMID: 34315232 (View on PubMed)

Cox JL, Parkash R, Abidi SS, Thabane L, Xie F, MacKillop J, Abidi SR, Ciaccia A, Choudhri SH, Abusharekh A, Nemis-White J; IMPACT-AF Investigators. Optimizing primary care management of atrial fibrillation: The rationale and methods of the Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) study. Am Heart J. 2018 Jul;201:149-157. doi: 10.1016/j.ahj.2018.04.008. Epub 2018 Apr 7.

Reference Type DERIVED
PMID: 29807323 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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IMPACT-AF-2013

Identifier Type: -

Identifier Source: org_study_id

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