Clinical trial NCT05026775: Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention
Official title: Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherence, Medication
Keywords: Complex Intervention
Real World Data
Cardiovascular Disease
Diabetes Mellitus
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Parc Sanitari Sant Joan de Déu
name: CIBER of Epidemiology and Public Health
name: Consell de Col·legis de Farmacèutics de Catalunya
name: Catalan Society of Family Medicine
First posted: 2021-08-30
Enrollment: 4153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Initiation
timeFrame: 1 month and 3 months after recruitment
Secondary outcomes:
measure: Rate of adherence
timeFrame: 1 year after recruitment
measure: Reduction of Cardiovascular Risk
timeFrame: 1 year after recruitment
Other outcomes:
measure: Visits to primary care
timeFrame: 1 year after recruitment
measure: Visits to secondary care
timeFrame: 1 year after recruitment
measure: Visits to emergency room
timeFrame: 1 year after recruitment
measure: Use of diagnostic tests
timeFrame: 1 year after recruitment
measure: Hospital admissions
timeFrame: 1 year after recruitment
measure: Use of medication
timeFrame: 1 year after recruitment
measure: Productivity loss
timeFrame: 1 year after recruitment
measure: Cardiovascular events
timeFrame: 1 year after recruitment
measure: Rate of Mortality
timeFrame: 1 year after recruitment
Locations:
city: Begues
country: Spain
facility: CAP Pou Torre
state: Barcelona
city: Calaf
country: Spain
facility: CAP Calaf
state: Barcelona
city: Corbera De Llobregat
country: Spain
facility: CAP Corbera de Llobregat
state: Barcelona
city: La Llagosta
country: Spain
facility: CAP La Llagosta
state: Barcelona
city: Martorell
country: Spain
facility: CAP Martorell
state: Barcelona
city: Montornès Del Vallès
country: Spain
facility: CAP Montornès del Vallès
state: Barcelona
city: Ripollet
country: Spain
facility: CAP Ripollet
state: Barcelona
city: Sant Boi De Llobregat
country: Spain
facility: CAP Vinyets
state: Barcelona
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
city: Sant Sadurní d'Anoia
country: Spain
facility: CAP Sant Sadurni d'Anoia
state: Barcelona
city: Sant Vicenç de Castellet
country: Spain
facility: CAP Sant Vicenç de Castellet
state: Barcelona
city: Sitges
country: Spain
facility: CAP Sitges
state: Barcelona
city: Montcada i Reixac
country: Spain
facility: CAP Montcada i Reixac
state: Barcelon
city: Sort
country: Spain
facility: CAP Sort
state: Lleida
city: Tremp
country: Spain
facility: CAP de Tremp
state: Lleida
city: Cornudella de Montsant
country: Spain
facility: CAP Cornudella de Montsant
state: Tarragona
city: Reus
country: Spain
facility: CAP Sant Pere
state: Tarragona
city: Santa Coloma De Queralt
country: Spain
facility: CAP Santa Coloma de Queralt
state: Tarragona
city: Barcelona
country: Spain
facility: CAP Drassanes
city: Barcelona
country: Spain
facility: CAP Horta
city: Barcelona
country: Spain
facility: CAP La Marina
city: Girona
country: Spain
facility: CAP Montilivi
city: Tarragona
country: Spain
facility: CAP Sant Pere i Sant Pau
city: Tarragona
country: Spain
facility: CAP Bonavista
Study officials:
References:
citation: 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.
citation: 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.