Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention
IMA-cRCT
1 other identifier
interventional
4,153
1 country
24
Brief Summary
The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedOctober 12, 2022
October 1, 2022
7 months
July 23, 2021
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Rate of adherence
1 year after recruitment
Reduction of Cardiovascular Risk
1 year after recruitment
Other Outcomes (9)
Visits to primary care
1 year after recruitment
Visits to secondary care
1 year after recruitment
Visits to emergency room
1 year after recruitment
- +6 more other outcomes
Study Arms (2)
Initial Medication Adherence (IMA) intervention
EXPERIMENTALGeneral 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 COMPARATORPatients 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.
Interventions
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.
Health professionals in the usual care group will prescribe medication and provide information as usual.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundació Sant Joan de Déulead
- Institut Català de la Salutcollaborator
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurinacollaborator
- Parc Sanitari Sant Joan de Déucollaborator
- CIBER of Epidemiology and Public Healthcollaborator
- Consell de Col·legis de Farmacèutics de Catalunyacollaborator
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)collaborator
Study Sites (24)
CAP Pou Torre
Begues, Barcelona, 08859, Spain
CAP Calaf
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
Related Publications (4)
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.
PMID: 40592577DERIVEDCorral-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.
PMID: 40484629DERIVEDCorral-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.
PMID: 36316078DERIVEDSanchez-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.
PMID: 35790915DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Quality and Patient Safety
Study Record Dates
First Submitted
July 23, 2021
First Posted
August 30, 2021
Study Start
March 1, 2022
Primary Completion
September 30, 2022
Study Completion
September 30, 2023
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
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.