Managing Appropriate Prescribing in COPD

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

Sponsors

Lead Sponsor: General Practitioners Research Institute

Collaborator: Boehringer Ingelheim

Source 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'.

Overall Status Not yet recruiting
Start Date November 1, 2020
Completion Date November 1, 2021
Primary Completion Date May 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of COPD patients with one or more 'medication-comorbidity clashes' 26 weeks
Secondary Outcome
Measure Time Frame
Percentages of patients with one or more inappropriately prescribed medication 26 weeks
Enrollment 418
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Desktop helper

Description: 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).

Intervention Type: Behavioral

Intervention Name: E-learning

Description: 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.

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janwillem Kocks, MD PhD Principal Investigator General Practitioners Research Institute
Overall Contact

Last Name: Iris van Geer, PhD

Phone: +31502113898

Email: [email protected]

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Usual care

Type: No Intervention

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.

Label: Only desktop helper

Type: Active Comparator

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).

Label: Only E-learning

Type: Active Comparator

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'.

Label: Both dekstop helper and e-learning

Type: Active Comparator

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'.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov