Managing Appropriate Prescribing in COPD

Summary

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'.

Conditions

• COPD
• Comorbidities and Coexisting Conditions

Interventions

BEHAVIORAL

Desktop helper

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).

BEHAVIORAL

E-learning

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.

Sponsors & Collaborators

• Boehringer Ingelheim

  collaborator INDUSTRY

• General Practitioners Research Institute

  lead NETWORK

Principal Investigators

• Janwillem Kocks, MD PhD · General Practitioners Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-16

Primary Completion

2022-12-01

Completion

2022-12-01

Countries

• Netherlands

Study Locations