Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 605
- Locations
- 5
- Primary Endpoint
- Rate of clinical registries related to diabetes mellitus II
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention group: IMA Intervention
General practitioners (GP) applied the IMA intervention to all patients receiving a new prescription for pharmacological treatments of cardiovascular disease or diabetes.
Following the IMA intervention, nurses and community pharmacists offered information support in line with the information provided by the GP. Professionals had the intervention support tools available (leaflets, website and dispensing alert in community pharmacies).
Intervention: Initial Medication Adherence (IMA) Intervention (Behavioral)
Control group
Healthcare professionals from the control group prescribed medication and provided information as usual.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Rate of clinical registries related to diabetes mellitus II
Time Frame: 5 months before and after recruitment
Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin * Glomerular filtrate * Blood glucose
Rate of clinical registries related to cardiovascular risk
Time Frame: 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 dyslipidemia
Time Frame: 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
Time Frame: 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 use of services
Time Frame: 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
Secondary Outcomes
- Outliers registries(5 months before and after recruitment)
- Missing registries(5 months before and after recruitment)
- Active diagnosis registry(5 months before and after recruitment)
Investigators
Maria Rubio-Valera
Head of Quality and Patient Safety
Fundació Sant Joan de Déu