Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention
NCT ID: NCT05026775
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4153 participants
INTERVENTIONAL
2022-03-01
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Investigator: Data analysists will not have information on which group is the intervention group when conducting the analysis.
Study Groups
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Initial Medication Adherence (IMA) intervention
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.
Initial 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.
Usual care
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.
Usual care
Health professionals in the usual care group will prescribe medication and provide information as usual.
Interventions
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Initial 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.
Usual care
Health professionals in the usual care group will prescribe medication and provide information as usual.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institut Català de la Salut
OTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Parc Sanitari Sant Joan de Déu
OTHER
CIBER of Epidemiology and Public Health
UNKNOWN
Consell de Col·legis de Farmacèutics de Catalunya
UNKNOWN
Catalan Society of Family Medicine
OTHER
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Maria Rubio-Valera
Head of Quality and Patient Safety
Locations
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CAP Pou Torre
Begues, Barcelona, Spain
CAP Calaf
Calaf, Barcelona, Spain
CAP Corbera de Llobregat
Corbera de Llobregat, Barcelona, Spain
CAP La Llagosta
La Llagosta, Barcelona, Spain
CAP Martorell
Martorell, Barcelona, Spain
CAP Montornès del Vallès
Montornès del Vallès, Barcelona, Spain
CAP Ripollet
Ripollet, Barcelona, Spain
CAP Vinyets
Sant Boi de Llobregat, Barcelona, Spain
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain
CAP Sant Sadurni d'Anoia
Sant Sadurní d'Anoia, Barcelona, Spain
CAP Sant Vicenç de Castellet
Sant Vicenç de Castellet, Barcelona, Spain
CAP Sitges
Sitges, Barcelona, Spain
CAP Montcada i Reixac
Montcada i Reixac, Barcelon, Spain
CAP Sort
Sort, Lleida, Spain
CAP de Tremp
Tremp, Lleida, Spain
CAP Cornudella de Montsant
Cornudella de Montsant, Tarragona, Spain
CAP Sant Pere
Reus, Tarragona, Spain
CAP Santa Coloma de Queralt
Santa Coloma de Queralt, Tarragona, Spain
CAP Drassanes
Barcelona, , Spain
CAP Horta
Barcelona, , Spain
CAP La Marina
Barcelona, , Spain
CAP Montilivi
Girona, , Spain
CAP Sant Pere i Sant Pau
Tarragona, , Spain
CAP Bonavista
Tarragona, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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948973
Identifier Type: -
Identifier Source: org_study_id
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