Clinical trial NCT05309356: Using Clinical Prediction Models to Improve Treatment for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: IMplementing Predictive Analytics Towards Efficient COPD Treatments (IMPACT) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Precision medicine
Clinical prediction models
Medication adherence
Prescription appropriateness
Decision aid
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
name: Vancouver Coastal Health
First posted: 2022-04-04
Enrollment: 1130
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will conduct a prospective, pragmatic two-year stepped-wedged cluster RCT to evaluate the impact of ACCEPT on the process of care, patient-reported, and clinical outcomes. The trial was designed based on 24 participating physicians, comprising the study clusters. All physicians will be assigned to the comparator arm (usual care) at the beginning of the study. After 6 months, under a sequential rollout, two randomly selected physicians will be reassigned to the intervention arm (ACCEPT) every month.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: COPD is a heterogenous and progressive disease of the airways that affects millions of people worldwide. However, current treatment guidelines fail to provide personalised, patient-centered disease management. In contrast, precision medicine emphasizes the tailoring of disease management to patient characteristics and values to optimize patient care and outcomes. Clinical prediction models (CPMs) are major enablers of precision medicine, and facilitate targeted therapies to patients who will benefit the most from them.

The investigators developed a CPM called ACCEPT that improves risk stratification for COPD patients by predicting the risk of exacerbation at an individual level and thereby enabling personalized, preventive disease management. Using a stepped wedged cluster randomized controlled trial (RCT), the investigators aim to evaluate the impact of integrating ACCEPT into routine COPD care at two outpatient respiratory clinics in Vancouver, British Columbia, Canada.

The 'stepped wedged' RCT has a cross-over design, with treatment assignment done in a uni-directional, staggered format that will provide opportunities to control for time trend. The total duration of the study is 30 months. There will be a one-month phase in period with patient recruitment and data collection starting on month two. The last physician assignment will occur in month 18, and patient recruitment will continue until month 24. Follow-up data will be collected until month 30 to ensure six months of follow-up data for all patients.

Primary and secondary outcomes will be analysed using generalized estimating equations to account for possible clustering of endpoints (multiple visits for each physician). Further, following the intention to treat principle, clusters (physicians) will be analyzed according to their randomized crossover time irrespective of whether crossover was achieved at the desired time.

Eligibility criteria: Inclusion Criteria:

* Are a legal Canadian resident
* Aged 35 years and older
* Can speak English
* Have a diagnosis of COPD

Exclusion Criteria:

• Are under 35 years of age

Primary outcomes:
measure: Prescription appropriateness
timeFrame: Cross-sectional: data collected during each patients initial study visit for the duration of the trial (24 months)
Secondary outcomes:
measure: Medication adherence
timeFrame: 1 year before and 1 year after initial study visit (day 1).
measure: Rate of moderate or severe exacerbations
timeFrame: 1 year before and 1 year after initial study visit.
measure: Self-reported medication adherence and beliefs
timeFrame: BMQ-COPD will be administered at baseline (study visit 1, day 1), month 3, and month 6
measure: Impact of COPD on patient's daily life
timeFrame: CAT will be administered at baseline (study visit 1, day 1), month 3, and month 6
measure: COPD patient's Quality of Life
timeFrame: EQ5D will be administered at baseline (study visit 1, day 1), month 3, and month 6
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Lung Centre, Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St Paul's Hospital, Heart and Lung Centre
state: British Columbia
Study officials:
References: