This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.
A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC). The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients. The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
605
The IMA intervention promotes health literacy and patient participation in the decision-making process during the recommendation and prescription of a new drug for the management of cardiovascular disease and diabetes. The IMA intervention has four main components: 1. Training for healthcare professionals (GPs, nurses, and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; 2. Intervention support tools; decision aids (leaflets and website) and implementation tools (dispensing alert in community pharmacies when dispensing insulins and antiplatelet drugs); 3. Shared decision-making process during the GP's consultation; and 4. Information support provided by the nurses and community pharmacists that use the intervention decision aids to explore the patients' doubts and standardise the discourse between primary healthcare professionals.
Patients received the usual care when being prescribed a new prescription for treatments of cardiovascular disease or diabetes. Nurses and community pharmacists were asked to also provide usual care to those patients. Community pharmacists from the control group had the dispensing alert available when dispensing insulins and antiplatelet drugs.
CAP Cornellà de Llobregat (La Gavarra)
Cornellà de Llobregat, Barcelona, Spain
Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)
el Prat de Llobregat, Barcelona, Spain
CAP Dr. Bartomeu Fabrés Anglada Gava 2
Gavà, Barcelona, Spain
CAP Florida Nord (CAP la Florida)
L'Hospitalet de Llobregat, Barcelona, Spain
Rate of clinical registries related to diabetes mellitus II
Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin * Glomerular filtrate * Blood glucose
Time frame: 5 months before and after recruitment
Rate of clinical registries related to dyslipidemia
Rate of registries recorded five months before and after the prescription of: * Total colesterol * HDL cholesterol * LDL colesterol
Time frame: 5 months before and after recruitment
Rate of clinical registries related to hypertension
Rate of registries recorded one to two months before and after the prescription of: * Systolic blood pressure * Diastolic blood pressure
Time frame: 2 months before and after recruitment
Rate of clinical registries related to cardiovascular risk
Rate of registries recorded five months before and after the prescription of: • REGICOR
Time frame: 5 months before and after recruitment
Rate of use of services
Rate of use of services recorded five months before and after the prescription of: * Visits to primary care (nurse, GP) * Referrals to secondary care * Productivity losses (sick leave days) * Outpatient diagnostic tests
Time frame: 5 months before and after recruitment
Active diagnosis registry
Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system.
Time frame: 5 months before and after recruitment
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CAP Florida Sud (CAP la Florida)
L'Hospitalet de Llobregat, Barcelona, Spain
Missing registries
Number of registries missing.
Time frame: 5 months before and after recruitment
Outliers registries
Number of registries with values out of their range.
Time frame: 5 months before and after recruitment