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. 2023 Feb 14;7(1):3.
doi: 10.1186/s41512-023-00140-6.

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study

Kristina D Michaux  1 , Rebecca K Metcalfe  1   2 , Paloma Burns  3 , Annalijn I Conklin  1   2 , Alison M Hoens  2   4 , Daniel Smith  5 , Laura Struik  6 , Abdollah Safari  1   7 , Don D Sin  3   8 , Mohsen Sadatsafavi  9   10   11 ; IMPACT Study Group
Collaborators, Affiliations

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study

Kristina D Michaux et al. Diagn Progn Res. .

Abstract

Introduction: Personalized disease management informed by quantitative risk prediction has the potential to improve patient care and outcomes. The integration of risk prediction into clinical workflow should be informed by the experiences and preferences of stakeholders, and the impact of such integration should be evaluated in prospective comparative studies. The objectives of the IMplementing Predictive Analytics towards efficient chronic obstructive pulmonary disease (COPD) treatments (IMPACT) study are to integrate an exacerbation risk prediction tool into routine care and to determine its impact on prescription appropriateness (primary outcome), medication adherence, quality of life, exacerbation rates, and sex and gender disparities in COPD care (secondary outcomes).

Methods: IMPACT will be conducted in two phases. Phase 1 will include the systematic and user-centered development of two decision support tools: (1) a decision tool for pulmonologists called the ACCEPT decision intervention (ADI), which combines risk prediction from the previously developed Acute COPD Exacerbation Prediction Tool with treatment algorithms recommended by the Canadian Thoracic Society's COPD pharmacotherapy guidelines, and (2) an information pamphlet for COPD patients (patient tool), tailored to their prescribed medication, clinical needs, and lung function. In phase 2, we will conduct a stepped-wedge cluster randomized controlled trial in two outpatient respiratory clinics to evaluate the impact of the decision support tools on quality of care and patient outcomes. Clusters will be practicing pulmonologists (n ≥ 24), who will progressively switch to the intervention over 18 months. At the end of the study, a qualitative process evaluation will be carried out to determine the barriers and enablers of uptake of the tools.

Discussion: The IMPACT study coincides with a planned harmonization of electronic health record systems across tertiary care centers in British Columbia, Canada. The harmonization of these systems combined with IMPACT's implementation-oriented design and partnership with stakeholders will facilitate integration of the tools into routine care, if the results of the proposed study reveal positive association with improvement in the process and outcomes of clinical care. The process evaluation at the end of the trial will inform subsequent design iterations before largescale implementation.

Trial registration: NCT05309356.

Keywords: Chronic obstructive pulmonary disease; Clinical prediction models; Decision aid; Prescription appropriateness; Process of care; Protocol; Sex and gender.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Steps in the decision support tool development for phase 1 of the IMPACT study. COPD, chronic obstructive pulmonary disease
Fig. 2
Fig. 2
The stepped-wedge cluster randomized trial design of the IMPACT study. Notes: Patterned cells represent run in period (1 month)
Fig. 3
Fig. 3
IMPACT study Intervention package. ACCEPT, Acute COPD Exacerbation Prevention Tool; ADI, ACCEPT decision intervention; COPD, chronic obstructive pulmonary disease; CTS, Canadian Thoracic Society
Fig. 4
Fig. 4
Participant flow chart. BMQ, Beliefs about Medicines Questionnaire; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; CTS, Canadian Thoracic Society; EQ5D, EuroQoL 5-dimension
See this image and copyright information in PMC

References

    1. GBD 2015 Chronic Respiratory Disease Collaborators Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017;5(9):691–706. doi: 10.1016/S2213-2600(17)30293-X. - DOI - PMC - PubMed
    1. WHO. Chronic obstructive pulmonary disease (COPD). WHO. Available from: http://www.who.int/respiratory/copd/en/. Cited 2016 Jun 15.
    1. Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, FitzGerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008;102(3):413–421. doi: 10.1016/j.rmed.2007.10.010. - DOI - PubMed
    1. The human and economic burden of COPD - a leading cause of hospital admission in Canada | Canadian Respiratory Guidelines. Available from: http://www.respiratoryguidelines.ca/the-human-and-economic-burden-of-cop.... Cited 2016 Jun 15.
    1. Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease: the GOLD science committee report 2019. Eur Respir J. 2019;53(5):1900164. doi: 10.1183/13993003.00164-2019. - DOI - PubMed

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