Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

Fundació Sant Joan de Déu4,153 enrolled

Overview

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.

A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated. A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted. PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre). The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

4,153

Conditions

Adherence, Medication

Interventions

Initial Medication Adherence (IMA)BEHAVIORAL

The IMA intervention is a shared-decision making intervention that promotes health literacy and patient participation in the decision making process during the recommendation and prescription of a new drug for the management of a cardiovascular disease and diabetes. The IMA intervention has four main components: training for healthcare professionals (general practitioners (GP), nurses and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; intervention decision aids (leaflets and website); implementation of the IMA intervention during the GP's consultation; and information support provided by the nurses and community pharmacists that will use the intervention decision aids to explore the patients's doubts and harmonise and standardise the discourse between primary healthcare professionals.

Usual careOTHER

Health professionals in the usual care group will prescribe medication and provide information as usual.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary Care health professionals and pharmacists who: * Agree to participate in the clinical trial and process evaluation. * Attend the training course * Are not plannig to be on sick leave during the study period (e.g. maternity leave). * Patients who: * Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial. * Are \>18 years old * Do not reject to participate

Locations (24)

CAP Pou Torre

Begues, Barcelona, Spain

CAP Calaf

Outcomes

Primary Outcomes

Rate of Initiation

Patients who receive a new prescription (a prescription is considered new if there is no previouos prescription from the same group in the previous 6 months) will be considered initiators if they fill-up their prescription in the community pharmacy. Prescription and dispensation databases will be compared to classify prescriptions as initiated and non-initiated.

Time frame: 1 month and 3 months after recruitment

Secondary Outcomes

Rate of adherence

Adherence will be calculated based on the Medication Possesion Ratio (MPR is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period).

Time frame: 1 year after recruitment

Reduction of Cardiovascular Risk

Framingham risk score will be calculated.

Time frame: 1 year after recruitment

Data from ClinicalTrials.gov

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