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

NCT05309356 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1130

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

Interventions

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.

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).

Sponsors & Collaborators

  • Providence Health & Services

    collaborator OTHER
  • Vancouver Coastal Health

    collaborator OTHER_GOV
  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2025-01-31
Completion
2025-07-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309356 on ClinicalTrials.gov