Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease of the airways that affects more than 2.5 million Canadians. The life-course of COPD is punctuated by acute episodes, called lung attacks or exacerbations, where patients experience an intense increase in symptoms that can last from a few days to a few weeks. Treatment is required to minimize the risk of exacerbations. Pharmacotherapy, namely with inhaled medications, is an important component of preventive strategies for exacerbations.
“The recommendations on preventive pharmacotherapy by clinical guidelines such as those developed by the Canadian Thoracic Society (CTS), are poorly followed in practice,” according to Mohsen Sadatsafavi, Associate Professor in the University of British Columbia (UBC) Faculty of Pharmaceutical Sciences.
“One reason could be that clinical guidelines often are based on simple classification of patients into low vs. high risk of exacerbations — for example, the CTS guideline considers a patient as high risk based on their exacerbation history in the previous 12 months. Physicians might consider these guidelines too simplistic as there are often several patient characteristics that determine their exacerbation risk. As well, patients are not given a numerical estimate of future risk, which is shown to affect their perception of risk and their adherence to the recommended treatment.”
Clinical prediction models (CPMs) that quantify individualized risk for each patient based on their individual characteristics can improve the accuracy of guideline recommendations and improve patient and provider adherence. One such CPM is the Acute COPD Exacerbation Prediction Tool (ACCEPT), developed and validated in the first stage of a research project known as the IMPACT (Implementing Predictive Analytics towards efficient COPD Treatments) study. ACCEPT predicts the risk of exacerbations in the next 12 months based on several patient-specific variables (including age, sex, lung function measures, symptom burden, smoking status, and exacerbation history).
According to Professor Sadatsafavi, while CPMs show great promise in improving patient care and outcomes, their implementation in clinical practice has been difficult because clinical prediction models are not easily integrated into clinical encounters. “The Clinical and Systems Transformation project in British Columbia (BC) is providing a unique opportunity through the implementation of a new electronic health record system in BC hospitals”, he says. “The IMPACT study is designed to embed ACCEPT with Canadian guidelines into the electronic health records together with a decision tool developed during the first stage of the IMPACT research study, resulting in what is called the ACCEPT Decision Intervention (ADI).”
After the approval of data access for Stage 2 of the IMPACT project, Professor Sadatsafavi led a team of researchers from Providence Health Care (PHC) and Vancouver Coastal Health Authority (VCH). The overall objective of this study was to evaluate the effect of the ADI, testing the impact of the tool on the quality of care that COPD patients receive.
The study sites for this randomized controlled trial include outpatient respiratory clinics at St Paul’s Hospital and Vancouver General Hospital. Because the ADI was integrated within electronic health records (EHR) systems at both hospitals as an element of routine care, all respirologists were expected to contribute data to this study. The standard of care (comparator) was practice as usual.
Patients diagnosed with COPD aged 35 or older were eligible for inclusion in the study. Study endpoints included medication adherence, quality of life, and lung attack rates. Stage 2 of the study involved one baseline study visit and two follow-up phone conversations at three and six months post-visit for secondary endpoints with participants who consented, as well as a data linkage component with administrative health data from BC Ministry of Health. A major objective of Stage 2 of this IMPACT study is the economic evaluation of ADI, assessing the overall value of integrating precision medicine tools into the forefront of patient care. Jeenat Mehareen, PhD candidate and a member of the study team, will lead the economic evaluation. This evaluation will use the comprehensive health services use records available within administrative health data.
Through a formal stakeholder analysis in the formative stages of this study, the team identified and engaged with three main knowledge user groups: health administrators in charge of the EHR systems, clinical guideline development committees (namely, the Canadian Thoracic Society), and patient groups (namely BC Lung Association). The latter is a patient advocacy group that will ensure the overall findings of this study will be communicated to the broader patient community.
Between March 2023 and June 2025, 22 practicing respirologists from both study sites contributed 1,111 outpatient COPD visits. With the completion of the trial, the investigators are now preparing a pamphlet summarizing the findings, which will be shared with all participating physicians. Links to the preprints or published reports of the study will also be provided.
PopData provided the research team with guidance and support throughout the Data Access Request process.
The Canadian Institutes of Health Research (CIHR) funded both stages of the IMPACT research effort.
