search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clinical Decision Support System for AF
Sponsored by
Jafna L Cox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring Clinical Decision Support System, Primary Health Care, Clinical Practice Guidelines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Capital District Health Authority
  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Clinical Decision Support System for AF

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With AF-related Emergency Department Visits
Individual element of primary outcome. AF-related emergency department visits.
Process of Care
Timely access to specialist consultation Timely access to echocardiograms Timely access to catheter ablations for AF and atrial flutter
Health Related Quality of Life
- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).
Costs
The costs associated with the development, implementation, and maintenance of CDSS. The costs associated with managing and treating patients with AF.
Cost Effectiveness
- Incremental cost effectiveness ratio between the interventional arm and the control arm
Number of Participations With CV Hospitalizations
Individual element of primary outcome. AF-related emergency department visits.

Full Information

First Posted
August 20, 2013
Last Updated
February 12, 2021
Sponsor
Jafna L Cox
Collaborators
McMaster University, Population Health Research Institute, St. Joseph's Healthcare Hamilton, Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01927367
Brief Title
Integrated Management Program Advancing Community Treatment of Atrial Fibrillation
Acronym
IMPACT-AF
Official Title
Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jafna L Cox
Collaborators
McMaster University, Population Health Research Institute, St. Joseph's Healthcare Hamilton, Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Clinical Decision Support System, Primary Health Care, Clinical Practice Guidelines

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Decision Support System for AF
Arm Type
Other
Arm Description
Providers randomized to use the Clinical Decision Support System (CDSS, a web-based tool).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care - providers are not eligible to access / use the CDSS.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support System for AF
Other Intervention Name(s)
CDSS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With AF-related Emergency Department Visits
Description
Individual element of primary outcome. AF-related emergency department visits.
Time Frame
12 months
Title
Process of Care
Description
Timely access to specialist consultation Timely access to echocardiograms Timely access to catheter ablations for AF and atrial flutter
Time Frame
12 months
Title
Health Related Quality of Life
Description
- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).
Time Frame
12 months
Title
Costs
Description
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
Title
Cost Effectiveness
Description
- Incremental cost effectiveness ratio between the interventional arm and the control arm
Time Frame
12 months
Title
Number of Participations With CV Hospitalizations
Description
Individual element of primary outcome. AF-related emergency department visits.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Major Bleeding
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jafna L Cox, MD, FRCPC, FACC
Organizational Affiliation
CDHA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syed Sibte Raza Abidi, MSc, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Study Director
Facility Information:
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) is not available due to ethics regulations.
Citations:
PubMed Identifier
34380542
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. Erratum In: Trials. 2022 Jul 5;23(1):547.
Results Reference
derived
PubMed Identifier
34315232
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.
Results Reference
derived
PubMed Identifier
29807323
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.
Results Reference
derived

Learn more about this trial

Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

We'll reach out to this number within 24 hrs