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

NCT05507177 | Completed

• 2 other identifiers: 1050610140022010002
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  collected retrospectively, 6 months after the start of the medication review

Study Arms (2)

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

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

Interventions

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

Group I

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• diagnosed with type I diabetes
• not understanding Dutch language
• not giving or not able to give informed consent

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38862899 DERIVED

MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: January 7, 2023
• Primary Completion: November 6, 2025
• Study Completion: January 13, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

NL (1)