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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Population Health Research Institute | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
| Bayer |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Decision Support System for AF | Other | Providers randomized to use the Clinical Decision Support System (CDSS, a web-based tool). |
|
| Usual Care | No Intervention | Usual Care - providers are not eligible to access / use the CDSS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support System for AF | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AF-related Emergency Department Visits |
| 12 months |
| Process of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jafna L Cox, MD, FRCPC, FACC | CDHA | Principal Investigator |
| Syed Sibte Raza Abidi, MSc, PhD | Dalhousie University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital District Health Authority | Halifax | Nova Scotia | B3H 3A7 | Canada | ||
| St. Joseph's Healthcare Hamilton |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39525336 | Derived | 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. | |
| 38685464 | Derived | 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. |
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Individual participant data (IPD) is not available due to ethics regulations.
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One participant did not meet inclusion criteria and was excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Usual Care - providers are not eligible to access / use the CDSS. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
Adverse events were collected over 12 months for each participant's active study phase.
Safety outcomes were monitored and reported at 12 months, including Major bleeding per ISTH criteria as well as All bleeding.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding per ISTH criteria | Vascular disorders | Systematic Assessment |
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Limitations can be found in the main outcomes paper, which is open access: https://www.sciencedirect.com/science/article/pii/S0002870320300855 The methods paper is also open access: https://www.sciencedirect.com/science/article/pii/S0002870318301170
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jafna L Cox | QEII Health Sciences Centre, Halifax, Nova Scotia | (902) 473-7811 | jafna.cox@dal.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2019 | Apr 16, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 26, 2017 | Apr 29, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| INDUSTRY |
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|
| 12 months |
| Health Related Quality of Life | - Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L). | 12 months |
| Costs |
| 12 months |
| Cost Effectiveness | - Incremental cost effectiveness ratio between the interventional arm and the control arm | 12 months |
| Number of Participations With CV Hospitalizations |
| 12 months |
| 12 months |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| 37853351 | Derived | 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. |
| 34380542 | Derived | 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. |
| 34315232 | Derived | 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. |
| 29807323 | Derived | 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. |
| BG001 | Usual Care | Usual Care - providers are not eligible to access / use the CDSS. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care | Usual Care - providers are not eligible to access / use the CDSS. |
|
|
| Secondary | Number of Participants With AF-related Emergency Department Visits |
| Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Process of Care |
| 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. | Posted | 12 months |
|
|
| Secondary | Health Related Quality of Life | - Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L). | Not Posted | Jun 2021 | 12 months | Participants |
| Secondary | Costs |
| Not Posted | Sep 2021 | 12 months | Participants |
| Secondary | Cost Effectiveness | - Incremental cost effectiveness ratio between the interventional arm and the control arm | Not Posted | Sep 2021 | 12 months | Participants |
| Secondary | Number of Participations With CV Hospitalizations |
| Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 28 |
| 590 |
| 9 |
| 590 |
| 0 |
| 590 |
| EG001 | Usual Care | Usual Care - providers are not eligible to access / use the CDSS. | 21 | 543 | 7 | 543 | 0 | 543 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |