Adherence, Medication
Conditions
Keywords
Pilot Study, Feasibility Study, Complex Intervention, Real-World Data, Cardiovascular Disease, Diabetes Mellitus
Brief summary
This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.
Detailed description
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).
Interventions
BEHAVIORALInitial Medication Adherence (IMA) Intervention
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.
OTHERUsual Care
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.
Sponsors
Parc Sanitari Sant Joan de Déu
Institut Català de la Salut
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Col·legi de Farmacèutics de la Província de Barcelona
CIBER of Epidemiology and Public Health
Fundació Sant Joan de Déu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
PC patients: Patients from the intervention PCCs received the IMA intervention but were not aware of the group they were assigned to.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary healthcare professionals and pharmacists who: • Agree to participate in the pilot study. Primary care patients who: * Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial. * Are \>18 years old. * Do not reject to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of use of services | 5 months before and after recruitment | 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 |
| Rate of clinical registries related to dyslipidemia | 5 months before and after recruitment | Rate of registries recorded five months before and after the prescription of: * Total colesterol * HDL cholesterol * LDL colesterol |
| Rate of clinical registries related to hypertension | 2 months before and after recruitment | Rate of registries recorded one to two months before and after the prescription of: * Systolic blood pressure * Diastolic blood pressure |
| Rate of clinical registries related to cardiovascular risk | 5 months before and after recruitment | Rate of registries recorded five months before and after the prescription of: • REGICOR |
| Rate of clinical registries related to diabetes mellitus II | 5 months before and after recruitment | Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin * Glomerular filtrate * Blood glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active diagnosis registry | 5 months before and after recruitment | Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system. |
| Missing registries | 5 months before and after recruitment | Number of registries missing. |
| Outliers registries | 5 months before and after recruitment | Number of registries with values out of their range. |
Countries
Spain
Outcome results
None listed