DeprescriptionsCO-DEPRESCRIBENCT05507177
Effects of Communication Training to Involve Older People in Decisions to DEPRESCRIBE Cardiometabolic Medication: a Cluster-randomized Trial in Primary Care
A study testing communication training programme for healthcare providers in people with Deprescriptions and Polypharmacy, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The researchers will investigate the effects of a communication training for community pharmacists and general physicians that aims to make it easier for them to stop or lower medication for cardiovascular disease and/or diabetes in older patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Deprescriptions, Polypharmacy, Primary Health Care
- What is being tested?
- communication training programme for healthcare providers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jan 2023to 13 Jan 2026
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Inclusion criteria for the patients that receive a clinical medication review as part of the study:
- 75 years or older
- eligible for a clinical medication review according to the Dutch guidlines
- using one or more of the following medications:
- sulfonylurea derivative; (b) insulin; (c) any 2 glucose-regulating medications; (d) any 2 blood pressure-lowering medications; (e) statin
- managed and monitored by one of the participating HCP teams
Exclusion criteria for the patients that receive a clinical medication review as part of the study:
- diagnosed with type I diabetes
- not understanding Dutch language
- not giving or not able to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The researchers will investigate the effects of a communication training for community pharmacists and general physicians that aims to make it easier for them to stop or lower medication for cardiovascular disease and/or diabetes in older patients.
The researchers expect that trained community pharmacists and general physicians will stop or lower medication for cardiovascular disease and/or diabetes in more patients compared to untrained community pharmacists and general physicians.
The researchers will recruit local teams consisting of a community pharmacist and one or more general physician, and allocate each team to either group I or group II. All teams in group I are first being trained, before they conduct a study-specific clinical medication review in 10 patients per team. All teams in group II will first conduct a more general clinical medication review in 10 patients per team too, before receiving the training. Patients will only be included after meeting in- and exlcusion criteria and signing an informed consent form. During the conduct of the study, the researchers will collect patient reported data and data on the conduct of the medication reviews. Retrospectively, the researchers will also collect data on the medication use of the patients from the pharmacy information system and specific medical data related to cardiometabolic disease of the patients from the physician's information system. The researchers will also assess the total costs and benefits of the intervention, and evaluate the training for the purpose of future implementation.
Read the detailed description
RESEARCH QUESTION: The researchers will investigate the effects of a communication training program for community pharmacists and general physicians, that aims to facilitate stopping or lowering the prescription of medication for cardiovascular disease and/or diabetes in older patients.
HYPOTHESIS: The researchers expect that the training program will lead to more proactive stopping or lowering the prescription of medication for cardiovascular disease and/or diabetes, and that patients will be more involved in the decision to stop or lower.
STUDY DESIGN: The researchers will conduct a cluster-randomized trial in which 44 pharmacist-general practice teams in the Netherlands will be randomized to conducting medication reviews with 10 eligible patients as usual (control) or after receiving the deprescribing communication training program (intervention). STUDY POPULATION: People of 75 years and older using specific cardiometabolic medication and eligible for a medication review in The Netherlands will be included.
INTERVENTION: The training program is based on previous work and applies models for patient-centered communication and shared decision making. The training consists of 5 modules with supportive tools.
OUTCOME MEASURES: Primary outcome is the proportion of patients with deintensified cardiometabolic medication.
Secondary outcomes include patient involvement in decision-making, healthcare professional communication skills assessed by the patient, medication-related outcomes, attitudes towards deprescribing, medication regimen complexity and health-related quality of life. Additional safety and cost parameters will be collected.
SAMPLE SIZE/DATA-ANALYSIS: Based on a pilot study, the researchers have estimated that 167 patients are needed per study arm in the final intention-to-treat analysis using a mixed effects model. Taking loss to follow-up into account, 40 teams need to recruit 10 patients each. The researchers will conduct a baseline and a 6-months follow-up assessment, a process evaluation using the RE-AIM framework, and a cost effectiveness analysis.
- Conditions
- Deprescriptions, Polypharmacy, Primary Health Care, Community Pharmacy Services, Decision Making, Shared
- Being tested
- communication training programme for healthcare providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication training programme for healthcare providersOther
the communication training programme is specifically designed to help Dutch primary care healthcare providers facilitate adequately deprescribing cardiometabolic medication in older patients
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | patients that are treated in group I receive a medication review from healthcare providers that have already received the communication training programme Receives: Other: communication training programme for healthcare providers |
| Group II | No intervention | patients that are treated in group II receive a medication review from healthcare providers that have not yet received the communication training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients in which one or more cardiometabolic medications is deprescribed
proportion of patients per study arm in which one or more medications for diabetes or cardiovascular disease has been lowered or stopped
Measured: collected retrospectively, 6 months after the start of the medication review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start7 Jan 2023
- Primary completion6 Nov 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeprescriptionsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First healthcare provider teams are recruited. After inclusion, a team is randomly allocated the group I (intervention, receiving a training before conducting medication reviews) or group II (control group, receiving training after conducting medication reviews). After the teams in group I have been trained, teams in both arms will conduct ten medication reviews per team in parallel.
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507177
- Sponsor's protocol ID
- 10506
- Other IDs
- 10140022010002
- Acronym
- CO-DEPRESCRIBE
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stuijt PJC, Heringa M, van Dijk L, Faber A, Burgers JS, Feenstra TL, Taxis K, Denig P. Effects of a multicomponent communication training to involve older people in decisions to DEPRESCRIBE cardiometabolic medication in primary care (CO-DEPRESCRIBE): protocol for a cluster randomized controlled trial with embedded process and economic evaluation. BMC Prim Care. 2024 Jun 11;25(1):210. doi: 10.1186/s12875-024-02465-7.
PubMed 38862899
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Communication Training to Involve Older People in Decisions to DEPRESCRIBE Cardiometabolic Medication: a Cluster-randomized Trial in Primary Care
- ClinicalTrials.gov ID
- NCT05507177
- Acronym / sponsor ID
- CO-DEPRESCRIBE / 10506
- Conditions
- Deprescriptions, Polypharmacy, Primary Health Care, Community Pharmacy Services, Decision Making, Shared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 18 Aug 2022 (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.
The researchers will investigate the effects of a communication training for community pharmacists and general physicians that aims to make it easier for them to stop or lower medication for cardiovascular disease and/or diabetes in older patients.
The researchers expect that trained community pharmacists and general physicians will stop or lower medication for cardiovascular disease and/or diabetes in more patients compared to untrained community pharmacists and general physicians.
The researchers will recruit local teams consisting of a community pharmacist and one or more general physician, and allocate each team to either group I or group II. All teams in group I are first being trained, before they conduct a study-specific clinical medication review in 10 patients per team. All teams in group II will first conduct a more general clinical medication review in 10 patients per team too, before receiving the training. Patients will only be included after meeting in- and exlcusion criteria and signing an informed consent form. During the conduct of the study, the researchers will collect patient reported data and data on the conduct of the medication reviews. Retrospectively, the researchers will also collect data on the medication use of the patients from the pharmacy information system and specific medical data related to cardiometabolic disease of the patients from the physician's information system. The researchers will also assess the total costs and benefits of the intervention, and evaluate the training for the purpose of future implementation.
Detailed description
RESEARCH QUESTION: The researchers will investigate the effects of a communication training program for community pharmacists and general physicians, that aims to facilitate stopping or lowering the prescription of medication for cardiovascular disease and/or diabetes in older patients.
HYPOTHESIS: The researchers expect that the training program will lead to more proactive stopping or lowering the prescription of medication for cardiovascular disease and/or diabetes, and that patients will be more involved in the decision to stop or lower.
STUDY DESIGN: The researchers will conduct a cluster-randomized trial in which 44 pharmacist-general practice teams in the Netherlands will be randomized to conducting medication reviews with 10 eligible patients as usual (control) or after receiving the deprescribing communication training program (intervention). STUDY POPULATION: People of 75 years and older using specific cardiometabolic medication and eligible for a medication review in The Netherlands will be included.
INTERVENTION: The training program is based on previous work and applies models for patient-centered communication and shared decision making. The training consists of 5 modules with supportive tools.
OUTCOME MEASURES: Primary outcome is the proportion of patients with deintensified cardiometabolic medication.
Secondary outcomes include patient involvement in decision-making, healthcare professional communication skills assessed by the patient, medication-related outcomes, attitudes towards deprescribing, medication regimen complexity and health-related quality of life. Additional safety and cost parameters will be collected.
SAMPLE SIZE/DATA-ANALYSIS: Based on a pilot study, the researchers have estimated that 167 patients are needed per study arm in the final intention-to-treat analysis using a mixed effects model. Taking loss to follow-up into account, 40 teams need to recruit 10 patients each. The researchers will conduct a baseline and a 6-months follow-up assessment, a process evaluation using the RE-AIM framework, and a cost effectiveness analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First healthcare provider teams are recruited. After inclusion, a team is randomly allocated the group I (intervention, receiving a training before conducting medication reviews) or group II (control group, receiving training after conducting medication reviews). After the teams in group I have been trained, teams in both arms will conduct ten medication reviews per team in parallel.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: communication training programme for healthcare providerspatients that are treated in group I receive a medication review from healthcare providers that have already received the communication training programme |
| Group II | No intervention | –patients that are treated in group II receive a medication review from healthcare providers that have not yet received the communication training programme |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| communication training programme for healthcare providersthe communication training programme is specifically designed to help Dutch primary care healthcare providers facilitate adequately deprescribing cardiometabolic medication in older patients | Other | Group I |
Primary outcome
proportion of patients in which one or more cardiometabolic medications is deprescribed
Time frame: collected retrospectively, 6 months after the start of the medication review
proportion of patients per study arm in which one or more medications for diabetes or cardiovascular disease has been lowered or stopped
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 2 Mar 2026.
- Derived from this study: PubMed 38862899Stuijt PJC, Heringa M, van Dijk L, Faber A, Burgers JS, Feenstra TL, Taxis K, Denig P. Effects of a multicomponent communication training to involve older people in decisions to DEPRESCRIBE cardiometabolic medication in primary care (CO-DEPRESCRIBE): protocol for a cluster randomized controlled trial with embedded process and economic evaluation. BMC Prim Care. 2024 Jun 11;25(1):210. doi: 10.1186/s12875-024-02465-7.
Related trials for Deprescriptions
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
RecruitingObservational study
Informative Exhibition for Deprescribing Benzodiazepines
Benzodiazepine-Related Disorders
Recruiting
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Benzodiazepine Withdrawal
RecruitingPhase 4
Anticholinergic Deprescription in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Not yet recruitingEarly Phase 1
Deprescription of Antidepressants in Primary Care (DAPriCare)
Deprescription, Antidepressants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication training programme for healthcare providers in people with Deprescriptions and Polypharmacy, run by University Medical Center Groningen 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?
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 2 Mar 2026. 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?
proportion of patients in which one or more cardiometabolic medications is deprescribed (time frame: collected retrospectively, 6 months after the start of the medication review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05507177, which also lists 1 linked publication.
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 2 Mar 2026.