Managing Appropriate Prescribing in COPD

Not Applicable

Completed

• Conditions: Comorbidities and Coexisting Conditions; COPD
• Interventions: Behavioral: E-learning; Behavioral: Desktop helper

• Registration Number: NCT04539457
• Lead Sponsor: General Practitioners Research Institute

Brief 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'.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-07
• Study Start: 2021-06-16
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Only E-learning	E-learning	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'.
Only desktop helper	Desktop helper	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).
Both dekstop helper and e-learning	Desktop helper	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'.
Both dekstop helper and e-learning	E-learning	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'.

Primary Outcome Measures

Name	Time	Method
Percentage of COPD patients with one or more 'medication-comorbidity clashes'	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 Outcome Measures

Name	Time	Method
Percentages of patients with one or more inappropriately prescribed medication	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

Trial Locations

Locations (1)

General Practitioners Research Institute; 🇳🇱 Groningen, Netherlands