Atrial Fibrillation
Conditions
Keywords
Clinical Decision Support System, Primary Health Care, Clinical Practice Guidelines
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.
Interventions
OTHERClinical 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.
Sponsors
McMaster University
Population Health Research Institute
St. Joseph's Healthcare Hamilton
Bayer
Jafna L Cox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AF-related Emergency Department Visits | 12 months | * Individual element of primary outcome. * AF-related emergency department visits. |
| Process of Care | 12 months | * Timely access to specialist consultation * Timely access to echocardiograms * Timely access to catheter ablations for AF and atrial flutter |
| Health Related Quality of Life | 12 months | \- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L). |
| Cost Effectiveness | 12 months | \- Incremental cost effectiveness ratio between the interventional arm and the control arm |
| Number of Participations With CV Hospitalizations | 12 months | * Individual element of primary outcome. * AF-related emergency department visits. |
| Costs | 12 months | * The costs associated with the development, implementation, and maintenance of CDSS. * The costs associated with managing and treating patients with AF. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Bleeding | 12 months | 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. |
Countries
Canada
Participant flow
Pre-assignment details
One participant did not meet inclusion criteria and was excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Clinical Decision Support System for AF Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
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. | 590 |
| Usual Care Usual Care - providers are not eligible to access / use the CDSS. | 543 |
| Total | 1,133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No baseline data | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Clinical Decision Support System for AF | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 10.1 | 72.1 years STANDARD_DEVIATION 9.9 | 72.3 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Ethnicity Caucasian | 329 Participants | 308 Participants | 637 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 45 Participants | 35 Participants | 80 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 216 Participants | 200 Participants | 416 Participants |
| Region of Enrollment Canada Rural Care Nova Scotia | 315 Participants | 298 Participants | 613 Participants |
| Region of Enrollment Canada Urban Care Nova Scotia | 275 Participants | 245 Participants | 520 Participants |
| Sex: Female, Male Female | 239 Participants | 193 Participants | 432 Participants |
| Sex: Female, Male Male | 351 Participants | 350 Participants | 701 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 590 | 21 / 543 |
| other Total, other adverse events | 0 / 590 | 0 / 543 |
| serious Total, serious adverse events | 9 / 590 | 7 / 543 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support System for AF | Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits | 118 Participants |
| Usual Care | Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits | 130 Participants |
Secondary
Cost Effectiveness
\- Incremental cost effectiveness ratio between the interventional arm and the control arm
Time frame: 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.
Time frame: 12 months
Secondary
Health Related Quality of Life
\- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).
Time frame: 12 months
Secondary
Number of Participants With AF-related Emergency Department Visits
* Individual element of primary outcome. * AF-related emergency department visits.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support System for AF | Number of Participants With AF-related Emergency Department Visits | 78 Participants |
| Usual Care | Number of Participants With AF-related Emergency Department Visits | 96 Participants |
Secondary
Number of Participations With CV Hospitalizations
* Individual element of primary outcome. * AF-related emergency department visits.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support System for AF | Number of Participations With CV Hospitalizations | 40 Participants |
| Usual Care | Number of Participations With CV Hospitalizations | 26 Participants |
Secondary
Process of Care
* Timely access to specialist consultation * Timely access to echocardiograms * Timely access to catheter ablations for AF and atrial flutter
Time frame: 12 months
Population: Data were not available/collected from primary care provider charts that would permit analysis of the time between dates of referral and dates of access for the process of care outcomes.
Other Pre-specified
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support System for AF | Number of Participants With Major Bleeding | 9 Participants |
| Usual Care | Number of Participants With Major Bleeding | 7 Participants |