Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— IMPACT-AF  

Official title:

Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927367
• Other study ID #: IMPACT-AF-2013
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2018

Study information

• Verified date: February 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1145
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Jafna L Cox	Bayer, McMaster University, Population Health Research Institute, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Major Bleeding	Major bleeding, as listed above, is to be defined as fatal bleeding and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and /or overt bleeding causing a fall in hemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.	12 months
Primary	Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits	Any unplanned hospitalization (admission with an overnight stay in hospital) due to one of the following causes: acute coronary syndrome, pre-syncope /syncope, transient ischemic attack/ stroke, atrial fibrillation, flutter, pulmonary embolism /deep vein thrombosis /systemic embolism, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin. AF-related ED visit was predefined as: any presentation with palpitations, rapid heart rate, presyncope or syncope, shortness of breath, transient chest discomfort, or hemodynamic instability resolving with cardioversion or rate-control, not resulting in hospitalization.	12 months
Secondary	Number of Participants With AF-related Emergency Department Visits	Individual element of primary outcome.; AF-related emergency department visits.	12 months
Secondary	Process of Care	Timely access to specialist consultation; Timely access to echocardiograms; Timely access to catheter ablations for AF and atrial flutter	12 months
Secondary	Health Related Quality of Life	- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).	12 months
Secondary	Costs	The costs associated with the development, implementation, and maintenance of CDSS.; The costs associated with managing and treating patients with AF.	12 months
Secondary	Cost Effectiveness	- Incremental cost effectiveness ratio between the interventional arm and the control arm	12 months
Secondary	Number of Participations With CV Hospitalizations	Individual element of primary outcome.; AF-related emergency department visits.	12 months

External Links

•   IMPACT-AF Rationale and methods
•   IMPACT-AF: A cluster randomized trial of a computerized clinical decision support tool