What side effects are associated with this type of intervention?

Common treatments for COPD include inhaled bronchodilators (short-acting and long-acting), inhaled corticosteroids, and combination therapies. Inhaled bronchodilators can cause side effects such as dry mouth, tremors, and palpitations. Inhaled corticosteroids may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Combination therapies, which include both bronchodilators and corticosteroids, can combine these side effects. Theophylline, used in refractory cases, has a narrow therapeutic window and can cause nausea, headaches, and arrhythmias. Antibiotics, used during exacerbations, can lead to gastrointestinal disturbances and antibiotic resistance.

What prior FDA approvals exist?

The FDA has approved several inhaled bronchodilators and combination therapies for the treatment of Chronic Obstructive Pulmonary Disease (COPD). These include long-acting beta agonists (LABAs) such as olodaterol and vilanterol, and long-acting muscarinic antagonists (LAMAs) like tiotropium. Combination inhalers that include LABA and LAMA, or LABA and inhaled corticosteroids (ICS), such as fluticasone furoate/vilanterol, have also been approved. These treatments aim to improve lung function, reduce symptoms, and decrease the frequency of exacerbations. Personalized care tools like the ACCEPT Risk Prediction Tool are being studied to further optimize treatment by predicting the risk of lung attacks and tailoring therapy to individual patient needs.

What other types of research exist?

Promising alternatives to the ACCEPT Risk Prediction Tool for COPD patients include: 1) A novel risk prediction model incorporating treatable traits, which has been externally validated and shown to outperform other risk indices for predicting hospitalizations. 2) The GOLD3D assessment tool, which includes separate assessments of lung function and exacerbation history, and has demonstrated improved ability to predict adverse events compared to previous GOLD guidelines.

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Clinical Prediction Model for COPD

N/A

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of COPD

Aged 35 years and older

Must not have

Under 35 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year before and 1 year after initial study visit.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a computer tool called ACCEPT that helps doctors predict severe lung attacks in COPD patients. By analyzing electronic health records, the tool aims to provide personalized care to prevent these attacks and improve patient outcomes.

Who is the study for?

This trial is for Canadian residents aged 35 or older who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and can communicate in English. It's not open to those under the age of 35.

What is being tested?

The study tests a digital tool called ACCEPT, integrated into electronic health records, to predict COPD patients' risk of lung attacks and improve personalized care at two hospitals in Vancouver, BC.

What are the potential side effects?

Since this trial involves a prediction tool rather than medication, traditional side effects are not applicable. However, there may be indirect impacts on patient care based on the tool's recommendations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with COPD.

Select...

I am 35 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year before and 1 year after initial study visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year before and 1 year after initial study visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year before and 1 year after initial study visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prescription appropriateness

Secondary study objectives

COPD patient's Quality of Life

Impact of COPD on patient's daily life

Medication adherence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACCEPT Decision InterventionExperimental Treatment1 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 II: Usual care (Control)Active Control1 Intervention

Routine COPD patient care.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators, inhaled corticosteroids, and systemic glucocorticoids. Inhaled bronchodilators, such as beta-agonists and muscarinic antagonists, work by relaxing the muscles around the airways, making it easier to breathe and improving airflow. Inhaled corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. Systemic glucocorticoids are used during acute exacerbations to quickly reduce inflammation and improve symptoms. These treatments are crucial for COPD patients as they help manage symptoms, reduce the risk of exacerbations, and improve overall quality of life. Personalized care tools like the ACCEPT Risk Prediction Tool can optimize these treatments by predicting the risk of lung attacks and tailoring therapy to individual patient needs.

A perspective for chronic obstructive pulmonary disease (COPD) management: six key clinical questions to improve disease treatment.COPD: it is time to change!A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.