Adherence, Medication
Conditions
Keywords
Complex Intervention, Real World Data, Cardiovascular Disease, Diabetes Mellitus
Brief 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.
Interventions
BEHAVIORALInitial 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.
OTHERUsual care
Health professionals in the usual care group will prescribe medication and provide information as usual.
Sponsors
Institut Català de la Salut
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Parc Sanitari Sant Joan de Déu
CIBER of Epidemiology and Public Health
Consell de Col·legis de Farmacèutics de Catalunya
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participant: The randomization is conducted at the primary care centre level. Patients from intervention areas will receive enhanced care but will not be aware of the group assigned. Investigator: Data analysists will not have information on which group is the intervention group when conducting the analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary Care health professionals and pharmacists who: * Agree to participate in the clinical trial and process evaluation. * Attend the training course * Are not plannig to be on sick leave during the study period (e.g. maternity leave). * Patients who: * Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial. * Are \>18 years old * Do not reject to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Initiation | 1 month and 3 months after recruitment | Patients who receive a new prescription (a prescription is considered new if there is no previouos prescription from the same group in the previous 6 months) will be considered initiators if they fill-up their prescription in the community pharmacy. Prescription and dispensation databases will be compared to classify prescriptions as initiated and non-initiated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence | 1 year after recruitment | Adherence will be calculated based on the Medication Possesion Ratio (MPR is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period). |
| Reduction of Cardiovascular Risk | 1 year after recruitment | Framingham risk score will be calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of diagnostic tests | 1 year after recruitment | Number of diagnostic tests used will be counted from electronic health records. |
| Hospital admissions | 1 year after recruitment | Number of inpatient and outpatient hospital admissions will be counted from electronic health records. |
| Use of medication | 1 year after recruitment | Number of medication boxes dispensed will be counted from electronic health records. |
| Visits to primary care | 1 year after recruitment | Number of visits to primary care will be counted from electronic health records. |
| Cardiovascular events | 1 year after recruitment | All incident events during follow-up, classified according to the International Classification of Diseases, 10th version (ICD10) collected in electronic health records. The events of interest include: Diabetes (E10-E14); dislipidemia (E78); hypertensive diseases (I10-I15); Ischemic heart diseases (I20-I25); other heart diseases (I50, I51); cerebrovascular diseases (I60-I69); diseases of arteries (I70-I79); glomerular diseases (N03, N08) and Acute kidney failure and chronic kidney disease (N17-N19). |
| Rate of Mortality | 1 year after recruitment | mortality data from electronic health records |
| Productivity loss | 1 year after recruitment | Sick leaves used as a proxy for productivity loss, counted from electronic health records. |
| Visits to secondary care | 1 year after recruitment | Number of visits to secondary care will be counted from electronic health records. |
| Visits to emergency room | 1 year after recruitment | Number of visits to ER will be counted from electronic health records. |
Countries
Spain
Outcome results
None listed