Using Clinical Prediction Models to Improve Treatment for Patients With Chronic Obstructive Pulmonary Disease (COPD)
IMplementing Predictive Analytics Towards Efficient COPD Treatments (IMPACT) Study
2 other identifiers
interventional
1,130
1 country
2
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease of the lungs that affects more than 2.5 million Canadians. Patients with COPD experience episodes of lung attacks (or exacerbations). During these attacks, patients experience an intense increase in symptoms, such as breathlessness and cough. It is challenging to decide which patients should be put on treatments that would reduce the risk of such lung attacks. The digitization of health records in many clinics and hospitals means complex risk prediction algorithms can be used to predict the risk of lung attacks to enable personalized care. In this study, our team will implement a risk prediction tool (called ACCEPT) into the electronic health records in two teaching hospitals in Vancouver, British Columbia (BC), Canada. A clinical study will be conducted to evaluate if the use of this tool results in patients with COPD receiving better care with better outcomes, and if they are more satisfied with the care they are receiving.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Mar 2023
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMay 10, 2023
May 1, 2023
1.8 years
March 14, 2022
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prescription appropriateness
Binary variable indicating the concordance between the physician- and ACCEPT-based treatment recommendations (0: discordant prescription, 1: concordant prescription). We will compare the percentage of prescription appropriateness between the two study arms. The prescription recommended by the physician during the clinical encounter will be recorded. After the encounter, a research coordinator will interview the patient, use ACCEPT to produce the ACCEPT-based optimal treatment for the patient. The physician prescription will be considered concordant if it is the same as the prescription based on the ACCEPT recommendation (or if ACCEPT suggests more than one eligible prescription, the physician prescription is one of them), otherwise it will be considered discordant.
Cross-sectional: data collected during each patients initial study visit for the duration of the trial (24 months)
Secondary Outcomes (5)
Medication adherence
1 year before and 1 year after initial study visit (day 1).
Rate of moderate or severe exacerbations
1 year before and 1 year after initial study visit.
Self-reported medication adherence and beliefs
BMQ-COPD will be administered at baseline (study visit 1, day 1), month 3, and month 6
Impact of COPD on patient's daily life
CAT will be administered at baseline (study visit 1, day 1), month 3, and month 6
COPD patient's Quality of Life
EQ5D will be administered at baseline (study visit 1, day 1), month 3, and month 6
Study Arms (2)
Usual care (Control)
ACTIVE COMPARATORRoutine COPD patient care.
ACCEPT Decision Intervention
EXPERIMENTALClinical prediction model (ACCEPT)-based treatment recommendations: The ACCEPT tool will display the predicted risk of exacerbations, and the corresponding treatment recommendations to the physicians. These recommendations will be provided in a non-mandatory 'directive' format where the physician can override the recommendation, but is required to provide a justification (pre-set choices and a free text).
Interventions
The intervention consists of the CPM (ACCEPT) that is integrated with a decision aid, together called the ACCEPT Decision Intervention (ADI). The ADI will provide physicians with a quantification of the exacerbation risk for each patient and the corresponding treatment recommendation, as well as information about the benefits and risks of different inhaled therapies to discuss with the patients. The intervention also includes a 1-page take-home pamphlet on evidence-based risk behaviour factor modification for COPD, tailored to the treatment recommendation.
The patient will receive the physician-recommended treatment for COPD (usual care). All physicians will be provided refresher training on the Canadian Thoracic Society COPD guidelines during the phase in period (month 1).
Eligibility Criteria
You may qualify if:
- Are a legal Canadian resident
- Aged 35 years and older
- Can speak English
- Have a diagnosis of COPD
You may not qualify if:
- Are under 35 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Providence Health & Servicescollaborator
- Vancouver Coastal Healthcollaborator
Study Sites (2)
The Lung Centre, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St Paul's Hospital, Heart and Lung Centre
Vancouver, British Columbia, V6Z1Y6, Canada
Related Publications (1)
Michaux KD, Metcalfe RK, Burns P, Conklin AI, Hoens AM, Smith D, Struik L, Safari A, Sin DD, Sadatsafavi M; IMPACT Study Group. IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study. Diagn Progn Res. 2023 Feb 14;7(1):3. doi: 10.1186/s41512-023-00140-6.
PMID: 36782301DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 14, 2022
First Posted
April 4, 2022
Study Start
March 21, 2023
Primary Completion
January 1, 2025
Study Completion
July 1, 2025
Last Updated
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data will be made available 1 year after study completion, indefinitely
- Access Criteria
- Data will be freely accessible and publicly available via the DRYAD initiative.
All data sets collected as part of this study, with the exception of the administrative health data, will be shared via the DRYAD initiative. The Dryad Digital Repository is a curated resource that makes research data discoverable, freely reusable, and citable. Dryad provides a general-purpose home for a wide diversity of data types. Study investigators will share anonymized (free from patient identifiers as well as any sensitive data that might identify specific patients \[e.g., extremely rare comorbid conditions\]). The linked administrative health data, however, will not be shared, as such data are under the stewardship of British Columbia's Ministry of Health and is protected by the provincial Freed of Information and Protection of Privacy Act which prohibits its sharing.