Clinical trial NCT01927367: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation
Official title: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Clinical Decision Support System
Primary Health Care
Clinical Practice Guidelines
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Population Health Research Institute
name: St. Joseph's Healthcare Hamilton
name: Bayer
First posted: 2013-08-22
Enrollment: 1145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With AF-related Emergency Department Visits
timeFrame: 12 months
measure: Process of Care
timeFrame: 12 months
measure: Health Related Quality of Life
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
measure: Cost Effectiveness
timeFrame: 12 months
measure: Number of Participations With CV Hospitalizations
timeFrame: 12 months
Other outcomes:
measure: Number of Participants With Major Bleeding
timeFrame: 12 months
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: CDHA
name: Jafna L Cox, MD, FRCPC, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Syed Sibte Raza Abidi, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.