COPDNCT04539457
Managing Appropriate Prescribing in COPD
A study testing Desktop helper and E-learning in people with COPD and Comorbidities and Coexisting Conditions, run by General Practitioners Research Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Comorbidities and Coexisting Conditions
- What is being tested?
- Desktop helper and E-learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jun 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Desktop helper, E-learning
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desktop helperBehavioural
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-learningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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 | 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). Receives: Behavioral: Desktop helper |
| Only E-learning | Active comparator | 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'. Receives: Behavioral: E-learning |
| Both dekstop helper and e-learning | Active comparator | 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'. Receives: Behavioral: Desktop helper; Behavioral: E-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of COPD patients with one or more 'medication-comorbidity clashes'
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).
Measured: 26 weeks
Secondary outcomes (1)
Percentages of patients with one or more inappropriately prescribed medication
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start16 Jun 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Janwillem Kocks, MD PhD, Principal investigator, General Practitioners Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539457
- Sponsor's protocol ID
- GPRI19209
- Status last verified
- Feb 2023
- First submitted
- 31 Aug 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04539457
- Acronym / sponsor ID
- GPRI19209
- Conditions
- COPD, Comorbidities and Coexisting Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- Boehringer Ingelheim
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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 | Behavioral: Desktop helperOnly 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). |
| Only E-learning | Active comparator | Behavioral: E-learningOnly 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'. |
| Both dekstop helper and e-learning | Active comparator | Behavioral: Desktop helper, Behavioral: E-learningBoth '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'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desktop helperThe '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). | Behavioural | Both dekstop helper and e-learning, Only desktop helper |
| E-learningThe 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. | Behavioural | Both dekstop helper and e-learning, Only E-learning |
Primary outcome
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).
1 secondary outcome
Percentages of patients with one or more inappropriately prescribed medication
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janwillem Kocks, MD PhD principal investigator
General Practitioners Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desktop helper and E-learning in people with COPD and Comorbidities and Coexisting Conditions, run by General Practitioners Research Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of COPD patients with one or more 'medication-comorbidity clashes' (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.