Managing Appropriate Prescribing in COPD

General Practitioners Research Institute

Status: Completed

Conditions: COPD; Comorbidities and Coexisting Conditions

Treatments: Behavioral: Desktop helper; Behavioral: E-learning

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04539457

GPRI19209

Details and patient eligibility

About

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'.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Usual care

No Intervention group

Description:

Neither the 'Desktop Helper (version 10)' will be integrated in the EMR system nor the 'e-learning' will be offered to GPs. However, to prevent attenuation of usual care, GPs will be free to adjust any medication on their own initiative or to use any other aid to decrease inappropriate prescribing in COPD patients.

Only desktop helper

Active Comparator group

Description:

Only the 'Desktop Helper (version 10)' will be integrated in the EMR system. Specifically, GPs will receive a notification about the 'Desktop Helper (version 10)'. This notification will inform general practitioners about the option in the Medicom Smart Module to identify COPD patients with comorbidities who have one or more 'medication-comorbidity clashes' (i.e. undesired interactions between medications for COPD and comorbid conditions).

Treatment:

Behavioral: Desktop helper

Only E-learning

Active Comparator group

Description:

Only the 'e-learning' will be offered to GPs. Herein, GPs, will be invited to perform an e-learning module which provide information about COPD and their (co)morbidities and the 'medication-comorbidity clashes'.

Treatment:

Behavioral: E-learning

Both dekstop helper and e-learning

Active Comparator group

Description:

Both 'Desktop Helper (version 10)' will be implemented in the EMR system. GPs will subsequently be notified about the possibility to detect COPD patients with 'medication-comorbidity clashes'. The implementation of the 'Desktop Helper (version 10), will be accompanied by e-learning offered to GPs. about COPD and their (co)morbidities and the 'medication-comorbidity clashes'.

Treatment:

Behavioral: Desktop helper

Behavioral: E-learning