Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

Adherence, Medication Clinical Trial

— IMA-cRCT  

Official title:

Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05026775
• Other study ID #: 948973
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4153
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication

Intervention

Behavioral:
• 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.

Other:
• Usual care
Health professionals in the usual care group will prescribe medication and provide information as usual.

Locations

Country	Name	City	State
Spain	CAP Drassanes	Barcelona
Spain	CAP Horta	Barcelona
Spain	CAP La Marina	Barcelona
Spain	CAP Pou Torre	Begues	Barcelona
Spain	CAP Calaf	Calaf	Barcelona
Spain	CAP Corbera de Llobregat	Corbera De Llobregat	Barcelona
Spain	CAP Cornudella de Montsant	Cornudella de Montsant	Tarragona
Spain	CAP Montilivi	Girona
Spain	CAP La Llagosta	La Llagosta	Barcelona
Spain	CAP Martorell	Martorell	Barcelona
Spain	CAP Montcada i Reixac	Montcada i Reixac	Barcelon
Spain	CAP Montornès del Vallès	Montornès Del Vallès	Barcelona
Spain	CAP Sant Pere	Reus	Tarragona
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 Santa Coloma de Queralt	Santa Coloma De Queralt	Tarragona
Spain	CAP Sitges	Sitges	Barcelona
Spain	CAP Sort	Sort	Lleida
Spain	CAP Bonavista	Tarragona
Spain	CAP Sant Pere i Sant Pau	Tarragona
Spain	CAP de Tremp	Tremp	Lleida

Sponsors (7)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Catalan Society of Family Medicine, CIBER of Epidemiology and Public Health, Consell de Col·legis de Farmacèutics de Catalunya, Institut Català de la Salut, Jordi Gol i Gurina Foundation, Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visits to primary care	Number of visits to primary care will be counted from electronic health records.	1 year after recruitment
Other	Visits to secondary care	Number of visits to secondary care will be counted from electronic health records.	1 year after recruitment
Other	Visits to emergency room	Number of visits to ER will be counted from electronic health records.	1 year after recruitment
Other	Use of diagnostic tests	Number of diagnostic tests used will be counted from electronic health records.	1 year after recruitment
Other	Hospital admissions	Number of inpatient and outpatient hospital admissions will be counted from electronic health records.	1 year after recruitment
Other	Use of medication	Number of medication boxes dispensed will be counted from electronic health records.	1 year after recruitment
Other	Productivity loss	Sick leaves used as a proxy for productivity loss, counted from electronic health records.	1 year after recruitment
Other	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
Other	Rate of Mortality	mortality data from electronic health records	1 year after recruitment
Primary	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	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
Secondary	Reduction of Cardiovascular Risk	Framingham risk score will be calculated.	1 year after recruitment