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Atrial FibrillationIMPACT-AFNCT01927367

Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

A study testing Clinical Decision Support System for AF in people with Atrial Fibrillation, run by Jafna L Cox at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
Clinical Decision Support System for AF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,145 participants
Where
2 sitesCanada
Study dates
Sep 2013to Nov 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >/= 18 years (no max age limit)
  • Confirmed atrial fibrillation.
  • Able to provide informed consent in English.

Who cannot join

  • Patients unable to provide informed consent.
  • Patients who are not expected to be alive at the end of the 12 month follow up.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Capital District Health Authority

    Halifax, Nova Scotia, B3H 3A7

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Clinical Decision Support System for AF
Keywords
Clinical Decision Support System, Primary Health Care, Clinical Practice Guidelines
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Decision Support System for AFOther

    Also called CDSS

    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.

Study groups in NCT01927367
Study groupRoleWhat they receive
Clinical Decision Support System for AFOtherProviders randomized to use the Clinical Decision Support System (CDSS, a web-based tool).
Receives: Other: Clinical Decision Support System for AF
Usual CareNo interventionUsual Care - providers are not eligible to access / use the CDSS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (6)

  1. Number of Participants With AF-related Emergency Department Visits

    • Individual element of primary outcome.
    • AF-related emergency department visits.

    Measured: 12 months

  2. Process of Care

    • Timely access to specialist consultation
    • Timely access to echocardiograms
    • Timely access to catheter ablations for AF and atrial flutter

    Measured: 12 months

  3. Health Related Quality of Life

    • Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).

    Measured: 12 months

  4. Costs

    • The costs associated with the development, implementation, and maintenance of CDSS.
    • The costs associated with managing and treating patients with AF.

    Measured: 12 months

  5. Cost Effectiveness

    • Incremental cost effectiveness ratio between the interventional arm and the control arm

    Measured: 12 months

  6. Number of Participations With CV Hospitalizations

    • Individual element of primary outcome.
    • AF-related emergency department visits.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01927367
Sponsor's protocol ID
IMPACT-AF-2013
Acronym
IMPACT-AF
Status last verified
Feb 2021
First submitted
20 Aug 2013
Last updated
9 Mar 2021
Data monitoring committee
No
Individual data sharing
No: Individual participant data (IPD) is not available due to ethics regulations.

Publications

  • 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.

    PubMed 39525336

  • 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.

    PubMed 38685464

  • 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.

    PubMed 37853351

  • 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.

    PubMed 34380542

  • 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.

    PubMed 34315232

  • 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.

    PubMed 29807323

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support System for AF in people with Atrial Fibrillation, run by Jafna L Cox at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01927367, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.

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