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Randomized Controlled Trial
. 2021 Aug 11;22(1):531.
doi: 10.1186/s13063-021-05488-y.

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

Joanna M Nemis-White  1 , Laura M Hamilton  2 , Sarah Shaw  3 , James H MacKillop  4 , Ratika Parkash  5 , Shurjeel H Choudhri  6 , Antonio Ciaccia  7 , Feng Xie  8   9 , Lehana Thabane  8   10   11   12   13 , Jafna L Cox  14   15   16 ; IMPACT-AF Investigators
Affiliations
Randomized Controlled Trial

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

Joanna M Nemis-White et al. Trials. .

Erratum in

Abstract

Background: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) was a pragmatic, cluster randomized trial assessing the effectiveness of a clinical decision support (CDS) tool in primary care, Nova Scotia, Canada. We evaluated if CDS software versus Usual Care could help primary care providers (PCPs) deliver individualized guideline-based AF patient care.

Methods: Key study challenges including CDS development and implementation, recruitment, and data integration documented over the trial duration are presented as lessons learned.

Results: Adequate resources must be allocated for software development, updates and feasibility testing. Development took longer than projected. End-user feedback suggested network access and broadband speeds impeded uptake; they felt further that the CDS was not sufficiently user-friendly or efficient in supporting AF care (i.e., repetitive alerts). Integration across e-platforms is crucial. Intellectual property and other issues prohibited CDS integration within electronic medical records and provincial e-health platforms. Double login and data entry were impediments to participation or reasons for provider withdrawal. Data integration challenges prevented easy and timely data access, analysis, and reporting. Primary care study recruitment is resource intensive. Altogether, 203 PCPs and 1145 of their patients participated, representing 25% of eligible providers and 12% of AF patients in Nova Scotia, respectively. The most effective provider recruitment strategy was in-office, small group lunch-and-learns. PCPs with past research experience or who led patient consent were top recruiters. The study office played a pivotal role in achieving patient recruitment targets.

Conclusions: A rapid growth in healthcare data is leading to widespread development of CDS. Our experience found practical issues to address for such applications to succeed. Feasibility testing to assess the utility of any healthcare CDS prior to implementation is recommended. Adequate resources are necessary to support successful recruitment for future pragmatic trials. CDS tools that integrate multiple co-morbid guidelines across eHealth platforms should be pursued.

Trial registration: ClinicalTrials.gov NCT01927367. Registered on August 22, 2013.

Keywords: Atrial fibrillation; Clinical decision support; Clinical trials; Informatics.

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Conflict of interest statement

J. C. reports grants from Bayer Inc. during the conduct of the study and personal fees from Bayer, Servier, and HLS Therapeutic, outside the submitted work. R.P. reports grants from Bayer and Pfizer during the conduct of the study. J.M.K. reports other fees from Merck Canada, Bayer, and Pfizer outside the submitted work. A.C. and S.H.C. are employees of Bayer Inc. J.N.W. reports personal fees from Nova Scotia Health Authority during the conduct of the study. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CDS design. AF, atrial fibrillation; ECG, electrocardiogram
Fig. 2
Fig. 2
CDS information flow. DB, database; CDS, computer decision support; VPN, virtual private network
See this image and copyright information in PMC

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