Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate a community pharmacist intervention aimed at improving medication adherence in patients starting newly prescribed medication for cardiovascular disease prevention. The main questions it aims to answer are: Does this community pharmacist intervention improve medication adherence? Which patients benefit the most from the intervention? How do patients experience the start-up of newly prescribed medication (which questions do they have and do they experience side effects?)? How do patients and pharmacists experience the intervention?

Official Title
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Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Conditions
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Cardiovascular Diseases, Cardiovascular Disease Prevention

Intervention / Treatment
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* Behavioral: community pharmacist intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with a first prescription for one of the following drug classes: antihypertensive drugs (= low-ceiling diuretics, beta blocking agents (excl. non-selective beta-blocking agents), ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers), lipid-lowering drugs (= statins), antidiabetic drugs (= metformin, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter 2 (SGLT2) inhibitors), or any combination thereof. Age 18 years or older Community-dwelling Exclusion Criteria: The drug is prescribed for a non-cardiovascular indication (e.g. beta-blocking agent for migraine prophylaxis) Communication with the patient is not possible (e.g. due to cognitive impairment, insufficient knowledge of Dutch or French language)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Community pharmacist intervention | Behavioral: community pharmacist intervention<br>* The community pharmacist intervention comprises 2 parts: (1) first prescription counseling (oral and written information), and (2) a follow-up consultation (by telephone or in person) 7-14 days later, to identify problems with adherence/treatment<br>|
| No Intervention: Control arm<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) | Patient-reported measure of medication adherence | At 6 weeks and at 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Possession Ratio (MPR) | Measure of medication adherence, using pharmacy refill records | Over 26 weeks post-baseline | 
| Discontinuation rate | % of patients discontinuing the medication | Over 26 weeks post-baseline | 
| Medication knowledge questionnaire | Questionnaire evaluating patient's basic knowledge about the medication | At 6 weeks and at 12 weeks follow-up | 
| Beliefs about Medicines Questionnaire (BMQ-Specific) | Questionnaire evaluating patient's beliefs about the necessity of prescribed medication for controlling their illness (Specific-Necessity) and their concerns about the potential adverse consequences of taking it (Specific-Concerns) | At 6 weeks and at 12 weeks follow-up | 
| Treatment response | Systolic and diastolic blood pressure for patients starting an antihypertensive drug; lipid levels (total cholesterol, LDL and HDL) for patients starting a lipid-lowering drug; HbA1c for patients starting an antidiabetic drug | At baseline and at 12 weeks follow-up | 
| Healthcare utilization | Number of general practitioner (GP) visits, specialist-physician visits, emergency department (ED) visits and hospital admissions | Over 12 weeks post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence