Effectiveness and cost-effectiveness of an intervention to improve Initial Medication Adherence to treatments for cardiovascular diseases and diabetes in primary care: study protocol for a pragmatic cluster randomised controlled trial and economic model (the IMA-cRCT study)

• Published in: BMC family practice Vol. 23; no. 1; pp. 170 - 20
• Main Authors: Sánchez-Viñas, Alba, Corral-Partearroyo, Carmen, Gil-Girbau, Montserrat, Peñarrubia-María, M Teresa, Gallardo-González, Carmen, Olmos-Palenzuela, María-Del-Carmen, Aznar-Lou, Ignacio, Serrano-Blanco, Antoni, Rubio-Valera, Maria
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05.07.2022; BioMed Central; BMC
• Subjects: Cardiovascular disease; Cardiovascular diseases; Cardiovascular Diseases - drug therapy; Catchment areas; Clinical decision making; Clinical outcomes; Clinical trials; Comparative analysis; Complex intervention; Cost analysis; Cost benefit analysis; Cost-effectiveness analysis; Decision making; Diabetes; Diabetes Mellitus - drug therapy; Diabetes therapy; Drug therapy; Economic aspects; Economic model; Economic models; Economics; Health care; Health care reform; Health education; Health literacy; Health risks; Health services; Humans; Hypoglycemic agents; Intervention; Life expectancy; Medical care, Cost of; Medical research; Medication Adherence; Medicine, Experimental; Methods; Models, Economic; Mortality; Patient compliance; Primary care; Primary Health Care; Randomized Controlled Trials as Topic; Shared decision-making; Study Protocol; Spain; United Kingdom; United States > US; Complex intervention; Medication adherence; Cost-effectiveness analysis; Economic model; Cardiovascular disease; Primary care; Shared decision-making
• ISSN: 2731-4553; 2731-4553; 1471-2296
• DOI: 10.1186/s12875-022-01727-6

Between 2 and 43% of patients who receive a new prescription in PC do not initiate their treatments. Non-initiation is associated with poorer clinical outcomes, more sick leave and higher costs to the healthcare system. Existing evidence suggests that shared decision-making positively impacts medication initiation. The IMA-cRCT assesses the effectiveness of the IMA intervention in improving adherence and clinical parameters compared to usual care in patients with a new treatment for cardiovascular disease and diabetes prescribed in PC, and its cost-effectiveness, through a cRCT and economic modelling. The IMA intervention is a shared decision-making intervention based on the Theoretical Model of Non-initiation. A cRCT will be conducted in 24 PC teams in Catalonia (Spain), randomly assigned to the intervention group (1:1), and community pharmacies in the catchment areas of the intervention PC teams. Healthcare professionals in the intervention group will apply the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment (no other prescription from the same pharmacological group in the previous 6 months). All the study variables will be collected from real-world databases for the 12 months before and after receiving a new prescription. Effectiveness analyses will assess impact on initiation, secondary adherence, cardiovascular risk, clinical parameters and cardiovascular events. Cost-effectiveness analyses will be conducted as part of the cRCT from a healthcare and societal perspective in terms of extra cost per cardiovascular risk reduction and improved adherence; all analyses will be clustered. Economic models will be built to assess the long-term cost-effectiveness of the IMA intervention, in terms of extra cost for gains in QALY and life expectancy, using clinical trial data and data from previous studies. The IMA-cRCT represents an innovative approach to the design and evaluation of behavioural interventions that use the principles of complex interventions, pragmatic trials and implementation research. This study will provide evidence on the IMA intervention and on a new methodology for developing and evaluating complex interventions. The results of the study will be disseminated among stakeholders to facilitate its transferability to clinical practice. ClinicalTrials.gov, NCT05026775 . Registered 30 August 2021.