Clinical trial NCT05507177: Effects of Communication Training to Involve Older People in Decisions to DEPRESCRIBE Cardiometabolic Medication: a Cluster-randomized Trial in Primary Care
Official title: Effects of Communication Training to Involve Older People in Decisions to DEPRESCRIBE Cardiometabolic Medication: a Cluster-randomized Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Deprescriptions
Polypharmacy
Primary Health Care
Community Pharmacy Services
Decision Making, Shared
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients in which one or more cardiometabolic medications is deprescribed
timeFrame: collected retrospectively, 6 months after the start of the medication review
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: