RESEARCH QUESTION: We will evaluate the effects of a deprescribing communication training program on deintensification of cardiometabolic medication in older patients in primary care.
HYPOTHESIS: Our hypothesis is that the training program will lead to more proactive and patient-centred deprescribing of cardiometabolic medication.
STUDY DESIGN: We will conduct a cluster-randomized trial in which 40 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, achieving personalized treatment goals, 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, we have estimated that we need 167 patients 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. We will conduct a baseline and a 6-months follow-up assessment, a process evaluation using the RE-AIM framework, and a cost effectiveness analysis.