Effects of Communication Training to Involve Older People in Decisions to DEPRESCRIBE Cardiometabolic Medication: a Cluster-randomized Trial in Primary Care (CO-DEPRESCRIBE)

February 27, 2026 updated by: University Medical Center Groningen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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:

    a) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
patients that are treated in group I receive a medication review from healthcare providers that have already received the communication training programme
Other: communication training programme for healthcare providers
the communication training programme is specifically designed to help Dutch primary care healthcare providers facilitate adequately deprescribing cardiometabolic medication in older patients
No Intervention: Group II
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
collected retrospectively, 6 months after the start of the medication review

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2023

Primary Completion (Actual)

November 6, 2025

Study Completion (Actual)

January 13, 2026

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10506
  • 10140022010002 (Other Grant/Funding Number: ZonMw)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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