Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

Not Applicable

Active, not recruiting

• Conditions: Adherence, Medication

• Registration Number: NCT05026775
• Lead Sponsor: Fundació Sant Joan de Déu

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.

Study Timeline

• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2022-03-01
• Primary Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Initiation	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 Outcome Measures

Name	Time	Method
Reduction of Cardiovascular Risk	1 year after recruitment	Framingham risk score will be calculated.
Rate of adherence	1 year after recruitment	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).

Trial Locations

Locations (24)

CAP Pou Torre; 🇪🇸 Begues, Barcelona, Spain

CAP Calaf; 🇪🇸 Calaf, Barcelona, Spain

CAP Corbera de Llobregat; 🇪🇸 Corbera De Llobregat, Barcelona, Spain

CAP La Llagosta; 🇪🇸 La Llagosta, Barcelona, Spain

CAP Martorell; 🇪🇸 Martorell, Barcelona, Spain

CAP Montornès del Vallès; 🇪🇸 Montornès Del Vallès, Barcelona, Spain

CAP Ripollet; 🇪🇸 Ripollet, Barcelona, Spain

CAP Vinyets; 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain

Parc Sanitari Sant Joan de Déu; 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain

CAP Sant Sadurni d'Anoia; 🇪🇸 Sant Sadurní d'Anoia, Barcelona, Spain

Scroll for more (14 remaining)