Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Adherence, Medication
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 4153
- Locations
- 24
- Primary Endpoint
- Rate of Initiation
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.
Detailed Description
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.
Investigators
Maria Rubio-Valera
Head of Quality and Patient Safety
Parc Sanitari Sant Joan de Déu
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Initiation
Time Frame: 1 month and 3 months after recruitment
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.
Secondary Outcomes
- Reduction of Cardiovascular Risk(1 year after recruitment)
- Rate of adherence(1 year after recruitment)