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| Name | Class |
|---|---|
| Institut Català de la Salut | OTHER |
| Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER |
| Parc Sanitari Sant Joan de Déu | OTHER |
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The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Medication Adherence (IMA) intervention | Experimental | General practitioners (GP) will apply the IMA intervention to all patients receiving a new prescription for treatment of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists will offer information support in line with the information provided by the GP. |
|
| Usual care | Active Comparator | Patients will receive the usual care when being prescribed a new prescription for treatment of cardiovascular disease or diabetes. Nurses and community pharmacists will be asked to also provide usual care to those patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Medication Adherence (IMA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Initiation | 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. | 1 month and 3 months after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adherence | 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). | 1 year after recruitment |
| Reduction of Cardiovascular Risk |
| Measure | Description | Time Frame |
|---|---|---|
| Visits to primary care | Number of visits to primary care will be counted from electronic health records. | 1 year after recruitment |
| Visits to secondary care | Number of visits to secondary care will be counted from electronic health records. |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Pou Torre | Begues | Barcelona | 08859 | Spain | ||
| CAP Calaf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40592577 | Derived | Corral-Partearroyo C, Sanchez-Vinas A, Aznar-Lou I, Penarrubia-Maria MT, Gil-Girbau M, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Effectiveness of a patient-centred complex intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): a pragmatic cluster randomised controlled trial using real-world data. BMJ Qual Saf. 2025 Jul 1:bmjqs-2024-018402. doi: 10.1136/bmjqs-2024-018402. Online ahead of print. | |
| 40484629 |
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The research team is not the data owner as they are only re-using information that is the property of the public health institutions. Consequently, meta-data cannot be published by the authors nor data can be identified with a DOI.
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| CIBER of Epidemiology and Public Health |
| UNKNOWN |
| Consell de Col·legis de Farmacèutics de Catalunya | UNKNOWN |
| Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) | OTHER |
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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.
|
| Usual care | Other | Health professionals in the usual care group will prescribe medication and provide information as usual. |
|
Framingham risk score will be calculated. |
| 1 year after recruitment |
| 1 year after recruitment |
| Visits to emergency room | Number of visits to ER will be counted from electronic health records. | 1 year after recruitment |
| Use of diagnostic tests | Number of diagnostic tests used will be counted from electronic health records. | 1 year after recruitment |
| Hospital admissions | Number of inpatient and outpatient hospital admissions will be counted from electronic health records. | 1 year after recruitment |
| Use of medication | Number of medication boxes dispensed will be counted from electronic health records. | 1 year after recruitment |
| Productivity loss | Sick leaves used as a proxy for productivity loss, counted from electronic health records. | 1 year after recruitment |
| Cardiovascular events | 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). | 1 year after recruitment |
| Rate of Mortality | mortality data from electronic health records | 1 year after recruitment |
| Calaf |
| Barcelona |
| 08280 |
| Spain |
| CAP Corbera de Llobregat | Corbera de Llobregat | Barcelona | 08757 | Spain |
| CAP La Llagosta | La Llagosta | Barcelona | 08120 | Spain |
| CAP Martorell | Martorell | Barcelona | 08760 | Spain |
| CAP Montornès del Vallès | Montornès del Vallès | Barcelona | 08170 | Spain |
| CAP Ripollet | Ripollet | Barcelona | 08291 | Spain |
| CAP Vinyets | Sant Boi de Llobregat | Barcelona | 08830 | Spain |
| Parc Sanitari Sant Joan de Déu | Sant Boi de Llobregat | Barcelona | 08830 | Spain |
| CAP Sant Sadurni d'Anoia | Sant Sadurní d'Anoia | Barcelona | 08770 | Spain |
| CAP Sant Vicenç de Castellet | Sant Vicenç de Castellet | Barcelona | 08295 | Spain |
| CAP Sitges | Sitges | Barcelona | 08870 | Spain |
| CAP Montcada i Reixac | Montcada i Reixac | Barcelon | 08110 | Spain |
| CAP Sort | Sort | Lleida | 25560 | Spain |
| CAP de Tremp | Tremp | Lleida | 25620 | Spain |
| CAP Cornudella de Montsant | Cornudella de Montsant | Tarragona | 43360 | Spain |
| CAP Sant Pere | Reus | Tarragona | 43202 | Spain |
| CAP Santa Coloma de Queralt | Santa Coloma de Queralt | Tarragona | 43420 | Spain |
| CAP Drassanes | Barcelona | 08001 | Spain |
| CAP Horta | Barcelona | 08032 | Spain |
| CAP La Marina | Barcelona | 08038 | Spain |
| CAP Montilivi | Girona | 17003 | Spain |
| CAP Sant Pere i Sant Pau | Tarragona | 43007 | Spain |
| CAP Bonavista | Tarragona | 43100 | Spain |
| Derived |
| Corral-Partearroyo C, Sanchez-Vinas A, Penarrubia-Maria MT, Gil-Girbau M, Aznar-Lou I, Palma-Vasquez C, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Implementation of a patient-centred complex intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): a mixed-methods process evaluation. BMJ Qual Saf. 2025 Jun 8:bmjqs-2024-018403. doi: 10.1136/bmjqs-2024-018403. Online ahead of print. |
| 36316078 | Derived | Corral-Partearroyo C, Sanchez-Vinas A, Gil-Girbau M, Penarrubia-Maria MT, Aznar-Lou I, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol. BMJ Open. 2022 Oct 31;12(10):e067468. doi: 10.1136/bmjopen-2022-067468. |
| 35790915 | Derived | Sanchez-Vinas A, Corral-Partearroyo C, Gil-Girbau M, Penarrubia-Maria MT, Gallardo-Gonzalez C, Olmos-Palenzuela MD, Aznar-Lou I, Serrano-Blanco A, Rubio-Valera M. 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). BMC Prim Care. 2022 Jul 5;23(1):170. doi: 10.1186/s12875-022-01727-6. |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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