Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention (IMA-cRCT)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adherence, Medication
• Intervention / Treatment: Behavioral: Initial Medication Adherence (IMA); Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08001
    • CAP Drassanes
  • Barcelona, Spain, 08032
    • CAP Horta
  • Barcelona, Spain, 08038
    • CAP La Marina
  • Girona, Spain, 17003
    • CAP Montilivi
  • Tarragona, Spain, 43007
    • CAP Sant Pere i Sant Pau
  • Tarragona, Spain, 43100
    • CAP Bonavista
  • Barcelon
    • Montcada i Reixac, Barcelon, Spain, 08110
      • CAP Montcada i Reixac
  • Barcelona
    • Begues, Barcelona, Spain, 08859
      • CAP Pou Torre
    • Calaf, Barcelona, Spain, 08280
      • CAP Calaf
    • Corbera De Llobregat, Barcelona, Spain, 08757
      • CAP Corbera de Llobregat
    • La Llagosta, Barcelona, Spain, 08120
      • CAP La Llagosta
    • Martorell, Barcelona, Spain, 08760
      • CAP Martorell
    • Montornès Del Vallès, Barcelona, Spain, 08170
      • CAP Montornès del Vallès
    • Ripollet, Barcelona, Spain, 08291
      • CAP Ripollet
    • Sant Boi De Llobregat, Barcelona, Spain, 08830
      • Parc Sanitari Sant Joan de Deu
    • Sant Boi De Llobregat, Barcelona, Spain, 08830
      • CAP Vinyets
    • Sant Sadurní d'Anoia, Barcelona, Spain, 08770
      • CAP Sant Sadurni d'Anoia
    • Sant Vicenç de Castellet, Barcelona, Spain, 08295
      • CAP Sant Vicenç de Castellet
    • Sitges, Barcelona, Spain, 08870
      • CAP Sitges
  • Lleida
    • Sort, Lleida, Spain, 25560
      • CAP Sort
    • Tremp, Lleida, Spain, 25620
      • CAP de Tremp
  • Tarragona
    • Cornudella de Montsant, Tarragona, Spain, 43360
      • CAP Cornudella de Montsant
    • Reus, Tarragona, Spain, 43202
      • Cap Sant Pere
    • Santa Coloma De Queralt, Tarragona, Spain, 43420
      • CAP Santa Coloma de Queralt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: Usual care; Health professionals in the usual care group will prescribe medication and provide information as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Framingham risk score will be calculated.	1 year after recruitment

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Cardiovascular Disease; Complex Intervention; Real World Data
• Other Study ID Numbers: 948973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No