Using Clinical Prediction Models to Improve Treatment for Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT05309356

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care (Control)

Routine COPD patient care.

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: OTHER

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).

ACCEPT Decision Intervention

Clinical 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).

Group Type: EXPERIMENTAL

ACCEPT Decision Intervention

Intervention Type: OTHER

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.

Interventions

ACCEPT Decision Intervention

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.

Intervention Type: OTHER

Comparator

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Sadatsafavi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Lung Centre, Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

St Paul's Hospital, Heart and Lung Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mohsen Sadatsafavi, MD, PhD

Role: CONTACT

mohsen.sadatsafavi@ubc.ca

(604) 827-3020

Don Sin, MD, MPH

Role: CONTACT

Don.Sin@hli.ubc.ca

(604) 806-8395

Facility Contacts

Prabjit Barn, PhD

Role: primary

prabjit.barn@vch.ca

604-875-4111 ext. 23137

Alexander Lin, BA

Role: primary

alexander.lin@ubc.ca

604-418-1207

References

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.

Reference Type: DERIVED

PMID: 36782301 (View on PubMed)

Other Identifiers

F20-05804

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H21-02348

Identifier Type: -

Identifier Source: org_study_id