Description of the pharmaceutical treatment advice in patients with respiratory symptoms in primary care setting (DEPART)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40357
• EU PAS number:
  EUPAS36118
• Study ID:
  40357
• Official title and acronym:
  Description of the pharmaceutical treatment advice in patients with respiratory symptoms in primary care setting (DEPART)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  In the Netherlands, 60% to 80% of all chronic obstructive lung diseases are treated by the general practitioner (GP). Misdiagnosis, underdiagnosis, not indicated treatment prescriptions are common. The asthma/chronic obstructive pulmonary disease (COPD) (AC) service was implemented in the northern part of the Netherlands to support GPs by providing a working diagnosis and treatment advice by the pulmonologists affiliated with the AC service. It is unclear whether these pharmacological recommendations are followed by GPs and whether there are explanatory factors that would explain the deviation from the treatment advice. Therefore, this study aims to investigate the concordance of the pharmacological advices provided by the AC service at the first visit and the patient-reported inhalation medication prescribed by the GP at visit two. The study population consist of patients (≥18 years) treated in primary care with a working diagnosis COPD, asthma or asthma/COPD overlap as provided by the AC service. Provided pharmacological treatment advice at visit one by the AC-service must be available. Patients will be excluded if no second visit is scheduled and if there is no patient-reported pharmacological information available during visit two. To this end, the percentages of concordance or discordance of the pharmacological treatment advice will be described, multivariate analysis will be performed to gain insight in explanatory differences between the two groups, and multivariate regression analysis will be performed to gain insight in possible predictors of deviation from the provided treatment advice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 08/05/2020

Actual: 08/05/2020

Study start date

Planned: 28/05/2020

Actual: 28/05/2020

Data analysis start date

Planned: 02/07/2020

Date of interim report, if expected

Planned: 17/08/2020

Actual: 17/08/2020

Date of final study report

Planned: 31/08/2021

Sources of funding

Other

More details on funding

General Practitioners Research Institute

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable