Quality Improvement Program for COPD

(PREVAIL Trial)

Recruiting at 2 trial locations

Overseen By David Price, FRCGP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Observational and Pragmatic Research Institute

Disqualifiers: EHR changes, Active research, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

126 Participants Needed

Trial Summary

What is the purpose of this trial?

A 3-year cluster randomized controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the CONQUEST Quality Improvement Program treatment for COPD?

The CONQUEST Quality Improvement Program aims to improve COPD care by implementing quality standards in healthcare systems, focusing on early intervention and management of high-risk patients. While specific effectiveness data for CONQUEST is not detailed, similar programs have shown improvements in quality of life and symptom management for COPD patients. ^{1 2 3 4 5}

How is the CONQUEST Quality Improvement Program treatment for COPD different from other treatments?

The CONQUEST Quality Improvement Program is unique because it focuses on integrating quality standards into routine care to optimize management for both diagnosed and undiagnosed COPD patients at higher risk of exacerbations, unlike traditional treatments that may not address these specific needs. ^{1 2 5 6 7}

Eligibility Criteria

This trial is for Primary Care Teams (PCTs) managing patients with high-risk chronic obstructive pulmonary disease (COPD). PCTs must not be involved in other COPD studies, planning to change their electronic health records provider or ownership during the study, and should be willing to potentially use a new quality improvement program.

Inclusion Criteria

I am open to being randomly assigned to either start with the CONQUEST program or receive usual care first.

My condition meets the high-risk criteria that can be treated.

Primary Care Teams (PCTs) must be able to function as a single randomization unit with low risk of contamination between participants and physicians due to the absence of blinding in the intervention

Exclusion Criteria

People who are currently involved in research or programs that could affect their participation in the CONQUEST program.

You are in the process of changing your electronic health record software or planning to change the ownership of your medical practice during the trial evaluation period.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the CONQUEST quality improvement program in primary care practices

6 months

Outcome Evaluation

Evaluation of the impact of the CONQUEST program on COPD exacerbations and cardiovascular or respiratory events

2 years

Follow-up

Participants are monitored for safety and effectiveness after the outcome evaluation period

6 months

Treatment Details

Interventions

• CONQUEST Quality Improvement Program

Trial Overview The trial is testing the CONQUEST Quality Improvement Program over three years. It compares how well this program works against usual care for patients with modifiable high-risk COPD. Teams are randomly chosen to either start with CONQUEST or continue regular care before getting the program later.

Participant Groups

Group I: Delayed Intervention Arm Experimental Treatment 1 Intervention

The CONQUEST quality improvement program will be rolled-out to the delayed intervention practices at the end of the outcome evaluation period.

Group II: CONQUEST Intervention Arm Experimental Treatment 1 Intervention

Intervention arm clusters will receive the CONQUEST quality improvement program.

CONQUEST Quality Improvement Program is already approved in European Union, United Kingdom for the following indications:

Approved in European Union as CONQUEST QIP for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Approved in United Kingdom as CONQUEST QIP for:

• COPD management in primary care

Who Is Running the Clinical Trial?

Observational and Pragmatic Research Institute

Lead Sponsor

Trials

1

Recruited

130+

The DARTNet Institute (DI)

Collaborator

Trials

1

Recruited

130+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Optimum Patient Care Global Limited

Collaborator

Trials

1

Recruited

130+

Findings from Research

The CONQUEST initiative developed four quality standards (QS) aimed at improving the management of chronic obstructive pulmonary disease (COPD) in primary and secondary care, focusing on early identification and intervention for patients at high risk of exacerbations.

These QS were created through a rigorous process involving 11 COPD experts and extensive literature review, ensuring that they are evidence-based and designed to optimize patient-centered care and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CONQUEST Quality Standards: For the Collaboration on Quality Improvement Initiative for Achieving Excellence in Standards of COPD Care. Pullen, R., Miravitlles, M., Sharma, A., et al.[2021]

In 2019, only 10% of patients with high-risk chronic obstructive pulmonary disease (COPD) were properly diagnosed and managed according to guidelines, highlighting significant gaps in care.

A concerning 81% of newly diagnosed high-risk patients lacked spirometry testing, and 52% had no evidence of receiving COPD medication, indicating poor adherence to evidence-based practices and opportunities for improvement in patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program. Kerr, M., Tarabichi, Y., Evans, A., et al.[2023]

An educational program for managing chronic obstructive pulmonary disease (COPD) significantly improved participants' quality of life by an average of 3.3 points, with 53.5% showing clinically relevant improvements.

Participants also increased their exercise capacity, walking an average of 20.76 meters further in 6 minutes after completing the program, along with reductions in dyspnoea and clinical risk, demonstrating the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of an educational program for respiratory rehabilitation of Chronic Obstructive Pulmonary Disease patients in Primary Care in improving the quality of life, symptoms, and clinical risk]. Blánquez Moreno, C., Colungo Francia, C., Alvira Balada, MC., et al.[2023]

The integrated management program (I1) for COPD patients led to a significant reduction in smoking rates and a decrease in exacerbations compared to the isolated intervention (I2), indicating its effectiveness in managing the disease over a follow-up period of 31.2 months.

While lung function and quality of life did not show significant changes in either group, the correct use of inhalers improved, suggesting that both management strategies can enhance patient adherence to treatment, which is crucial for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is the introduction of clinical management programs for patients with chronic obstructive pulmonary disease useful? Comparison of the effectiveness of two interventions on the clinical progress and care received]. Solanes, I., Bolíbar, I., Llauger, MA., et al.[2019]

A significant number of high-risk COPD patients are not receiving timely assessments or treatments, with 41% of newly diagnosed patients lacking spirometry records and 45% not having a medication review within 6 months of diagnosis.

For already diagnosed patients, 39% did not have their exacerbation rates considered, and 46% were not referred for pulmonary rehabilitation, indicating a critical gap in adherence to management guidelines and quality standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of key opportunities for optimising the management of high-risk COPD patients in the UK using the CONQUEST quality standards: an observational longitudinal study. Halpin, DMG., Dickens, AP., Skinner, D., et al.[2023]

The INSPIRED COPD Outreach Program™ has successfully improved care for patients with advanced COPD in Canada, demonstrating that early sustainability planning is crucial for the long-term success of healthcare initiatives.

The study found that teams that focused on sustainability from the beginning were not only more likely to maintain the program but also improved their ability to spread knowledge and skills across different contexts, enhancing overall healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond implementation: A collective case study exploring the conceptions and facilitators of sustainability in a quality improvement collaborative. daSilva, M., Dissanayake, M., Sibbald, SL.[2023]

The INSPIRED COPD Outreach Program™ was successfully implemented across 19 teams in Canada, leading to significant improvements in patient self-confidence, daily activities, and quality of life for those with COPD.

Quality-of-care improvements were observed in various teams, with reductions in hospital admissions and emergency visits, demonstrating that a well-structured collaborative approach can enhance COPD management in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spreading improvements for advanced COPD care through a Canadian Collaborative. Rocker, GM., Amar, C., Laframboise, WL., et al.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

CONQUEST Quality Standards: For the Collaboration on Quality Improvement Initiative for Achieving Excellence in Standards of COPD Care. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of an educational program for respiratory rehabilitation of Chronic Obstructive Pulmonary Disease patients in Primary Care in improving the quality of life, symptoms, and clinical risk]. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

[Is the introduction of clinical management programs for patients with chronic obstructive pulmonary disease useful? Comparison of the effectiveness of two interventions on the clinical progress and care received]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Identification of key opportunities for optimising the management of high-risk COPD patients in the UK using the CONQUEST quality standards: an observational longitudinal study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Beyond implementation: A collective case study exploring the conceptions and facilitators of sustainability in a quality improvement collaborative. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Spreading improvements for advanced COPD care through a Canadian Collaborative. [2018]