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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

IMplementing Predictive Analytics Towards Efficient COPD Treatments (IMPACT) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309356
• Other study ID #: H21-02348
• Secondary ID: F20-05804
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Mohsen Sadatsafavi, MD, PhD
• Phone: (604) 827-3020
• Email: mohsen.sadatsafavi[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1130
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
Canada	St Paul's Hospital, Heart and Lung Centre	Vancouver	British Columbia
Canada	The Lung Centre, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Providence Health & Services, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication adherence	Medication adherence will be measured by the Medication Possession Ratio, defined as the ratio of the total days' supply dispensed to the total days' supply prescribed during the study period. This outcome will be assessed by linking patient data to BC's administrative health databases using each individual's unique Personal Health Number.	1 year before and 1 year after initial study visit (day 1).
Secondary	Rate of moderate or severe exacerbations	This outcome will be assessed by linking patient data to BC's administrative health databases using each individual's unique Personal Health Number. Moderate exacerbations will be defined any outpatient physician visit for COPD followed by filling prescriptions for antibiotic or oral corticosteroids. Severe exacerbations will be define as hospital admission with the main discharge code of COPD.	1 year before and 1 year after initial study visit.
Secondary	Self-reported medication adherence and beliefs	COPD-specific Beliefs about Medicines Questionnaire (BMQ)	BMQ-COPD will be administered at baseline (study visit 1, day 1), month 3, and month 6
Secondary	Impact of COPD on patient's daily life	Measured by the COPD Assessment Test (CAT)	CAT will be administered at baseline (study visit 1, day 1), month 3, and month 6
Secondary	COPD patient's Quality of Life	Measured by the EuroQoL 5-dimension (EQ5D) questionnaire	EQ5D will be administered at baseline (study visit 1, day 1), month 3, and month 6