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Quality Improvement Program
Quality Improvement Program for COPD (PREVAIL Trial)
N/A
Recruiting
Research Sponsored by Observational and Pragmatic Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during implementation and outcome evaluation period, 2.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a quality improvement and clinical decision support package can improve outcomes for patients with modifiable high-risk chronic obstructive pulmonary disease.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on a quality improvement program rather than a medication, it does not have traditional side effects. However, there may be indirect impacts on patient care processes and outcomes which will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during implementation and outcome evaluation period, 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during implementation and outcome evaluation period, 2.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
1a: COPD Exacerbations and 1b) major cardiac or respiratory events
Secondary study objectives
Systemic corticosteroid use (SCS)
Other study objectives
Exploratory Objective 1: The rate of explanatory diagnoses other than COPD
Exploratory Objective 2: Lung function
Exploratory Objective 3: Health status
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
Group I: Delayed Intervention ArmExperimental Treatment1 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 ArmExperimental Treatment1 Intervention
Intervention arm clusters will receive the CONQUEST quality improvement program.
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Who is running the clinical trial?
Observational and Pragmatic Research InstituteLead Sponsor
The DARTNet Institute (DI)UNKNOWN
AstraZenecaIndustry Sponsor
4,403 Previous Clinical Trials
289,124,883 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are currently involved in research or programs that could affect their participation in the CONQUEST program.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.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.
Research Study Groups:
This trial has the following groups:- Group 1: CONQUEST Intervention Arm
- Group 2: Delayed Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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