Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

University Ghent1,600 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,600

Conditions

Cardiovascular Diseases Cardiovascular Disease Prevention

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)

Patient-reported measure of medication adherence

Time frame: At 6 weeks and at 12 weeks follow-up

Secondary Outcomes

Medication Possession Ratio (MPR)

Measure of medication adherence, using pharmacy refill records

Time frame: Over 26 weeks post-baseline

Discontinuation rate

% of patients discontinuing the medication

Time frame: Over 26 weeks post-baseline

Medication knowledge questionnaire

Questionnaire evaluating patient's basic knowledge about the medication

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Over 12 weeks post-baseline

Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts