跳至主要内容
临床试验/NCT05507177
NCT05507177Enrolling By Invitation不适用

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

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
proportion of patients in which one or more cardiometabolic medications is deprescribed

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

proportion of patients in which one or more cardiometabolic medications is deprescribed

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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