Quality Improvement Program for COPD

(PREVAIL Trial)

Recruiting at 2 trial locations

Overseen By Rodger Kessler, PhD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a quality improvement program for people with chronic obstructive pulmonary disease (COPD), a lung condition that makes breathing difficult. The goal is to determine if the CONQUEST Quality Improvement Program can better support doctors and care teams in managing COPD compared to usual care. The trial involves two groups: one will try the new program immediately, while the other will continue with regular care before eventually switching to the new program. The trial seeks primary care teams with patients who have high-risk COPD and are open to trying new care methods. As an unphased trial, this study offers a unique opportunity to contribute to innovative care improvements for COPD management.

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 prior data suggests that the CONQUEST Quality Improvement Program is safe for patients with COPD?

Research shows that the CONQUEST Quality Improvement Program aims to enhance care for people with chronic obstructive pulmonary disease (COPD). This program identifies and manages patients who might experience worsening symptoms or sudden breathing issues. Since it focuses on improving care rather than introducing new drugs or medical procedures, it usually poses low risk.

Studies on similar programs indicate they are generally safe and well-tolerated. By enhancing healthcare delivery without adding new treatments, these programs typically have no direct side effects. For any concerns, discussing them with the trial staff is advisable, as they can provide more details on what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONQUEST Quality Improvement Program for COPD because it focuses on enhancing the overall care process for patients, rather than introducing a new medication. Unlike traditional treatments that mainly involve bronchodilators or steroids to manage symptoms, this program aims to improve outcomes by optimizing healthcare delivery and patient management practices. By implementing this quality improvement protocol, the hope is to not only improve patient health but also reduce hospital readmissions and enhance the efficiency of COPD management. This approach could lead to lasting changes in how COPD is treated, providing benefits that go beyond what medications alone can achieve.

What evidence suggests that the CONQUEST Quality Improvement Program is effective for COPD?

Research has shown that the CONQUEST Quality Improvement Program, which participants in this trial may receive, can help people with chronic obstructive pulmonary disease (COPD) by reducing flare-ups and hospital visits. Studies have found that this program focuses on identifying high-risk patients and enhancing their care. Early results suggest that improved care leads to better health outcomes for patients. The program sets clear guidelines for doctors to follow, aiming to reduce the chances of severe COPD episodes. Overall, evidence supports that these changes can significantly improve COPD management. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8370848/

CONQUEST Quality Standards: For the Collaboration on ... CONQUEST quality standards for the identification and management of patients with COPD at risk of exacerbations or acute respiratory events.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34413639/

CONQUEST Quality Standards: For the Collaboration on ... CONQUEST is the first-of-its-kind, collaborative, interventional COPD registry. It comprises an integrated quality improvement program focusing on patients.

3. dovepress.com dovepress.com/conquest-a-quality-improvement-program-for-defining-and-optimizing-sta-peer-reviewed-fulltext-article-PROM

CONQUEST: a QIP for Patients with Modifiable High-Risk ... A quality improvement program for defining and optimizing standards of care for modifiable high-risk COPD patients.

4. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(23)00120-5/fulltext

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

5. researchgate.net researchgate.net/publication/358791484_CONQUEST_A_Quality_Improvement_Program_for_Defining_and_Optimizing_Standards_of_Care_for_Modifiable_High-Risk_COPD_Patients

(PDF) CONQUEST: A Quality Improvement Program for ... As its main objectives, CONQUEST aims to improve patient health outcomes by reducing COPD exacerbations, COPD-related hospital admissions/ ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05306743

Study Details | NCT05306743 | PRagmatic EVAluation of a ... The intervention will implement validated algorithms (appropriately adapted for CONQUEST) to identify patients with modifiable high-risk COPD or undiagnosed ...