Clinical trial NCT06659666: The COPD Optimiser
Official title: Opportunities to Optimize COPD Management Using the COPD Optimiser Online Tool in Dutch General Practice
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COPD
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: AstraZeneca
First posted: 2024-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirmatory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

Brief summary: Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.

Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.

Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.

Primary objective

1. Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of COPD (ICPC R95),
* Capacity to understand and provide written informed consent.

Exclusion Criteria:

* Active diagnosis of Asthma (ICPC R96)
* Patients participating in an interventional clinical trial

Primary outcomes:
measure: patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD.
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Co-occurance and concordance of GOLD-based management suggestions
timeFrame: Immediately after the procedure
Other outcomes:
measure: User experience of healthcare providers & participants
timeFrame: Immediately after the procedure for SUS. For the exploratory interviews, through study completion, within 12 weeks of study end
Locations:
city: Groningen
country: Netherlands
facility: General practices in Netherlands
city: Groningen
country: Netherlands
facility: GPRI
Study officials:
References: