NCT05026775

Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,153 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adherence, Medication

Interventions

Type	Name	Description
BEHAVIORAL	Initial Medication Adherence (IMA)	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.
OTHER	Usual care	Health professionals in the usual care group will prescribe medication and provide information as usual.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-09-30
• Completion: 2023-09-30
• First posted: 2021-08-30
• Last updated: 2022-10-12

Locations

24 sites across 1 country: Spain