Clinical trial NCT04539457: Managing Appropriate Prescribing in COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Comorbidities and Coexisting Conditions
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: Boehringer Ingelheim
First posted: 2020-09-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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'.


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.

Primary outcomes:
measure: Percentage of COPD patients with one or more 'medication-comorbidity clashes'
timeFrame: 26 weeks
Secondary outcomes:
measure: Percentages of patients with one or more inappropriately prescribed medication
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: General Practitioners Research Institute
Study officials:
affiliation: General Practitioners Research Institute
name: Janwillem Kocks, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: