Completed

NCT Number: NCT05507177

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

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.

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Key information

Conditions

Deprescriptions Community Pharmacy Services Decision Making, Shared Polypharmacy Primary Health Care

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

communication training programme for healthcare providers

Other

the communication training programme is specifically designed to help Dutch primary care healthcare providers facilitate adequately deprescribing cardiometabolic medication in older patients

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: CO-DEPRESCRIBE

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Aug 18, 2022
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed