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Completed

NCT Number: NCT04539457

Managing Appropriate Prescribing in COPD

Objective: Reducing inappropriate medications for primary care COPD patients with comorbidities ('medication-comorbidity clashes'), by evaluation of the Desktop Helper (number 10) in a pragmatic cluster randomized controlled trial.

Study design: A four-arm pragmatic cluster randomized controlled trial (cluster RCT), which will be conducted in GP practices in the Netherlands. In the cluster RCT, the control condition (arm 1: care as usual) will be compared with three intervention arms (i.e. arm 2: the 'Desktop Helper (number 10)' , arm 3: an e-learning module, and arm 4: the 'Desktop Helper (number 10)' accompanied by the e-learning module). At baseline and at 26 weeks of follow-up, a data-extraction of comorbidities and prescribed medications will be obtained from the EMR of participating GP practices.

Study population: Primary care patients with COPD who have 1 or more comorbidities and who are prescribed one or more medications.

Intervention (if applicable): Clinical rules to remediate 'medication-comorbidity clashes' as outlined in the 'Desktop Helper (number 10)'. These clinical rules will be implemented in the EMR to enable the identification of patients with 'medication-comorbidity clashes'. In addition, e-learning about these 'medication-comorbidity clashes' will be offered depending on the treatment arm of the trial.

Main study parameters/endpoints: The number of 'medication-comorbidity clashes'.

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Key information

Conditions

COPD Chronic Disease Comorbidities and Coexisting Conditions Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Practitioners Research Institute

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary care patients with COPD aged 18 years and older with one or more (co)morbidities.
  • A clinical GP diagnosis of COPD (ICPC code R95 (emphysema/COPD).
  • Presence of one or more of the following (co)morbidities: Glaucoma (ICPC code F93*), Kidney failure / renal insufficiency (ICPC code: U99.01), Tuberculosis (ICPC code: A70, R70), Diabetes (ICPC code: T90, A91.05), Pneumonia (ICPC code: R81, R81.01), Osteoporosis/osteopenia (ICPC code: L95, L95.02, L95.01), Prostate symptoms (ICPC code: Y06, U05.02), Atrium fibrillation (ICPC code: K78, K79, K80, K84.02, K04, K05), Bronchiectasis (ICPC code: R91, R91.02) and Asthma (ICPC code: R96, R96.02)

Exclusion criteria

  • Have end-stage COPD or a life expectancy < 6 months
  • If they underwent a systematic medication review aimed at reducing inappropriate prescribing. Systematic refers to a collaboration with a pharmacist and the adoption of Beers, STOPP and or START criteria.

Treatment and study plan

Desktop helper

Behavioral

The 'Desktop Helper (version 10)' is a user-friendly information sheet developed by the IPCRG. This 'Desktop Helper (version 10)' has been developed in co-operation with several clinicians and experts in the field of COPD. These practical guidance and support are a tool for clinicians working in primary care. The 'Desktop Helper (version 10)' contains specific advice to prevent clashes. The specific advice of the 'Desktop Helper (version 10)' will be elaborated in decision trees. These will be integrated and implemented into the MedicomSmart system by Stichting Healthbase. Subsequently, these decision trees will provide GPs to conduct case-finding of COPD patients with 'medication-comorbidity clashes'. These are based on the 'Desktop Helper (version 10)' . Case finding will be done by the GP or the practice nurse (POH).

E-learning

Behavioral

The e-learning module will be explanatory to the 'Desktop Helper (version 10)' how to perform the case-finding and in what way the case-finding can be beneficial to the patients with COPD and their (co)morbidities. This e-learning module will include several example cases and how to deal with the case-finding and the next steps in the process to reduce the (co)morbidity clashes with the medications of COPD. Together with the decision trees as inferred from the 'Desktop Helper (version 10)', the e-learning module is aimed at inducing a behavioral change in prescribing medication to a patient suffering from COPD and one or more (co)morbidities.

Primary outcomes

  1. Percentage of COPD patients with one or more 'medication-comorbidity clashes'

    Time frame: 26 weeks

    The primary outcome of the study is the percentage of COPD patients with one or more 'medication-comorbidity clashes' (i.e. undesired interactions between medications for COPD and comorbid conditions).

Secondary outcomes

  1. Percentages of patients with one or more inappropriately prescribed medication

    Time frame: 26 weeks

    This outcome includes:

    • ICS prescription to patients with diabetes, a history of pneumonia, osteoporosis/osteopenia, bronchiectasis, tuberculosis, glaucoma
    • LABA prescription to patients with atrium fibrillation
    • LAMA prescription to patients with chronic kidney disease, prostate symptoms, glaucoma
    • No ICS prescription in patients with asthma

Sponsors and collaborators

Lead sponsor

General Practitioners Research Institute

Network

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Managing Appropriate Prescribing in Primary Care COPD Patients With Comorbidities: Evaluation of the Desktop Helper (Number 10) in a Pragmatic Cluster Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2020
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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