Clinical Prediction Model for COPD

Not currently recruiting at 1 trial location

Overseen By Don Sin, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Under 35 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool called ACCEPT Decision Intervention, which helps doctors predict the risk of lung attacks in patients with Chronic Obstructive Pulmonary Disease (COPD). The goal is to determine if using ACCEPT improves patient care and outcomes. Researchers are testing it in two hospitals in Vancouver, BC. Canadian residents who speak English and have been diagnosed with COPD might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance COPD care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ACCEPT Decision Intervention Tool is safe for use in predicting COPD exacerbations?

Research has shown that tools like the ACCEPT Decision Intervention are generally safe. These tools assist doctors in making better decisions by predicting the risk of lung problems in COPD patients and suggesting treatments based on electronic health records.

Several studies have examined the safety of using these tools in hospitals. Reports indicate that they are well-tolerated and do not cause harm, instead enhancing doctors' ability to care for patients. One study found these tools crucial for improving hospital care for COPD patients.

While specific data on the ACCEPT tool itself might be lacking, the overall safety of similar tools appears promising. Patients can feel confident that using these systems to manage COPD is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACCEPT Decision Intervention for COPD because it introduces a predictive model that personalizes treatment recommendations. Unlike the standard care where treatments are often generalized, this tool displays a patient's specific risk of exacerbations and tailors advice accordingly. The ACCEPT model offers a unique directive format that allows doctors to make informed decisions while still retaining flexibility to override suggestions with justification. This innovative approach aims to enhance decision-making and potentially improve patient outcomes by aligning treatments more closely with individual patient needs.

What evidence suggests that the ACCEPT Decision Intervention tool is effective for COPD?

Research has shown that the ACCEPT Decision Intervention tool, tested in this trial, can help predict lung attacks in people with Chronic Obstructive Pulmonary Disease (COPD). This tool provides doctors with a method to estimate a patient's likelihood of experiencing a lung attack. Studies have found that using this tool can enhance patient care by aiding doctors in making better treatment decisions. The tool's recommendations are based on real patient data, allowing for more personalized care. Although the tool is new, early results suggest it could significantly improve patient health by reducing the frequency and severity of lung attacks. Participants in this trial will receive either usual care or care guided by the ACCEPT tool. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with COPD.

Legal Canadian resident

I am 35 years old or older.

Exclusion Criteria

I am younger than 35 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person)

Treatment

Implementation of the ACCEPT tool in routine COPD care to provide personalized treatment recommendations

24 months

Multiple visits (in-person) as per routine care

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Data collection until month 30

Data Collection and Analysis

Data collected for primary and secondary outcomes, including prescription appropriateness and medication adherence

Throughout the trial

What Are the Treatments Tested in This Trial?

Interventions

• ACCEPT Decision Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: ACCEPT Decision Intervention Experimental Treatment 1 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 Control 1 Intervention

Routine COPD patient care.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Vancouver Coastal Health

Collaborator

Trials

41

Recruited

717,000+

Published Research Related to This Trial

The BOSA index, developed from a study of 300 patients and validated in a larger cohort of 772 patients, effectively predicts mortality in COPD patients by assessing factors like BMI, airflow obstruction, and health-related quality of life.

Compared to the GOLD 2011 criteria, the BOSA index shows similar prognostic utility, making it a simple and accessible tool for categorizing COPD patients without the need for complex equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of BMI, airflow obstruction, St George's Respiratory Questionnaire and age index in prognostication of Asian COPD. Chan, HP., Mukhopadhyay, A., Chong, PL., et al.[2022]

The implementation of a decision support tool for COPD patients significantly improved adherence to discharge recommendations, with long-acting medication prescriptions increasing from 42% to 84% and smoking cessation advice from 32% to 91%.

Patients who received prescriptions for long-acting bronchodilators were more likely to purchase them after discharge (54% vs. 20%), indicating that the tool not only improved guideline adherence but also had the potential to enhance patient outcomes post-hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support System: A Pragmatic Tool to Improve Acute Exacerbation of COPD Discharge Recommendations. Epstein, D., Barak-Corren, Y., Isenberg, Y., et al.[2020]

The updated Acute Chronic Obstructive Pulmonary Disease Exacerbation Prediction Tool (ACCEPT 2.0) demonstrated improved accuracy in predicting COPD exacerbations, achieving an area-under-the-curve (AUC) of 0.76 compared to the standard method, which had an AUC of 0.68.

ACCEPT 2.0 was well calibrated for patients with both positive and negative exacerbation histories, indicating its effectiveness across different patient profiles, and it provided a positive net benefit over traditional methods for predicting exacerbation risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACCEPT 2·0: Recalibrating and externally validating the Acute COPD exacerbation prediction tool (ACCEPT). Safari, A., Adibi, A., Sin, DD., et al.[2022]

The GOLD3D classification system, which incorporates lung function and exacerbation history, significantly improves the prediction of adverse events in COPD patients compared to the previous GOLD2011 and GOLD2017 systems, based on a study of 1303 patients over an average follow-up of 45 months.

GOLD3D demonstrated a higher accuracy in predicting both mortality and severe exacerbations, indicating that assessing lung function alongside exacerbation history provides a more comprehensive risk assessment for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new, three-dimensional approach to the GOLD COPD assessment tool. Golpe, R., Figueira-GonÇalves, JM., Amado, CA., et al.[2022]

This study evaluated the prognostic ability of the ADO, BODEx, and DOSE indices in predicting mortality among 477 COPD patients in primary care across 36 health centers in Europe, highlighting the need for individualized patient assessment.

The research aims to enhance the predictive capacity of these indices by considering the interval between exacerbations and incorporating lifestyle factors, which could improve communication and treatment strategies among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort). Espantoso-Romero, M., Román Rodríguez, M., Duarte-Pérez, A., et al.[2019]

A predictive model was developed to screen for Chronic Obstructive Pulmonary Disease (COPD) in smokers, using simple parameters like age, smoking history, and respiratory symptoms, based on a study of 222 smokers without a prior COPD diagnosis.

The model showed good internal validation for predicting fixed airflow limitation, with 25.7% of participants exhibiting this condition, and can be integrated into a mobile app for easier access, although it requires external validation in other regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoring system to detect fixed airflow limitation in smokers from simple easy-to-use parameters. Román-Conejos, E., Palazón-Bru, A., Folgado-de la Rosa, DM., et al.[2019]

A systematic review of 217 studies revealed that COPD patients prioritize symptom relief over adverse events, highlighting the importance of managing symptoms in treatment plans.

Among the outcomes, COPD patients rated exacerbations and hospitalizations due to exacerbations as the most critical factors affecting their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of how patients value COPD outcomes. Zhang, Y., Morgan, RL., Alonso-Coello, P., et al.[2019]

The COLIBRI-COPD web portal has successfully collected comprehensive data from 1079 COPD patients, highlighting significant variability in patient characteristics and treatment responses even among those with the same GOLD stage of the disease.

The high data quality and completeness suggest that this real-life data collection method can provide valuable longitudinal insights into COPD management, influenced by the usability of the web tool and self-assessment features for practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COLIBRI: Improving clinical practice and producing relevant scientific data]. Kelkel, E., Herengt, F., Ben Saidane, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9926816/

IMplementing Predictive Analytics towards efficient COPD ... The IMPACT study has two main objectives: (1) to integrate exacerbation risk prediction into routine COPD care by (a) designing a decision tool ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04990180

A Pulmonary Rehabilitation Shared Decision Making ... The second objective of this study is to test the feasibility and acceptability of a shared decision making intervention (a patient decision aid ...

3. nature.com nature.com/articles/s41746-025-01871-0

Evaluation of an integrated digital and mobile intervention ... Pulmonary rehabilitation improves outcomes in chronic obstructive pulmonary disease independent of disease burden. Ann. Am. Thorac. Soc. 14 ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00304-2/fulltext

ACCEPT 2·0: Recalibrating and externally validating the ... The Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Prediction Tool (ACCEPT) was developed for individualised prediction of COPD exacerbations.

5. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-03056-x

Assessing the comparative effects of interventions in COPD To optimize patient outcomes, healthcare decisions should be based on the most up-to-date high-quality evidence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10714883/

Clinical decision support systems for chronic obstructive ... The use of CDS systems in the management of patients with COPD in hospital-related settings is an important emerging field of research.