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

Sponsor

Fundació Sant Joan de Déu (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026775

Collaborator

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

3,600

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adherence, Medication	Behavioral: Initial Medication Adherence (IMA) Other: Usual care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of Initiation [1 month and 3 months after recruitment]
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.

Secondary Outcome Measures

Rate of adherence [1 year after recruitment]
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).
Reduction of Cardiovascular Risk [1 year after recruitment]
Framingham risk score will be calculated.

Other Outcome Measures

Visits to primary care [1 year after recruitment]
Number of visits to primary care will be counted from electronic health records.
Visits to secondary care [1 year after recruitment]
Number of visits to secondary care will be counted from electronic health records.
Visits to emergency room [1 year after recruitment]
Number of visits to ER will be counted from electronic health records.
Use of diagnostic tests [1 year after recruitment]
Number of diagnostic tests used will be counted from electronic health records.
Hospital admissions [1 year after recruitment]
Number of inpatient and outpatient hospital admissions will be counted from electronic health records.
Use of medication [1 year after recruitment]
Number of medication boxes dispensed will be counted from electronic health records.
Productivity loss [1 year after recruitment]
Sick leaves used as a proxy for productivity loss, counted from electronic health records.
Cardiovascular events [1 year after recruitment]
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).
Rate of Mortality [1 year after recruitment]
mortality data from electronic health records

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAP Pou Torre	Begues	Barcelona	Spain	08859
2	CAP Calaf	Calaf	Barcelona	Spain	08280
3	CAP Corbera de Llobregat	Corbera De Llobregat	Barcelona	Spain	08757
4	CAP La Llagosta	La Llagosta	Barcelona	Spain	08120
5	CAP Martorell	Martorell	Barcelona	Spain	08760
6	CAP Montornès del Vallès	Montornès Del Vallès	Barcelona	Spain	08170
7	CAP Ripollet	Ripollet	Barcelona	Spain	08291
8	CAP Vinyets	Sant Boi De Llobregat	Barcelona	Spain	08830
9	Parc Sanitari Sant Joan de Déu	Sant Boi De Llobregat	Barcelona	Spain	08830
10	CAP Sant Sadurni d'Anoia	Sant Sadurní d'Anoia	Barcelona	Spain	08770
11	CAP Sant Vicenç de Castellet	Sant Vicenç de Castellet	Barcelona	Spain	08295
12	CAP Sitges	Sitges	Barcelona	Spain	08870
13	CAP Montcada i Reixac	Montcada i Reixac	Barcelon	Spain	08110
14	CAP Sort	Sort	Lleida	Spain	25560
15	CAP de Tremp	Tremp	Lleida	Spain	25620
16	CAP Cornudella de Montsant	Cornudella de Montsant	Tarragona	Spain	43360
17	CAP Sant Pere	Reus	Tarragona	Spain	43202
18	CAP Santa Coloma de Queralt	Santa Coloma De Queralt	Tarragona	Spain	43420
19	CAP Drassanes	Barcelona		Spain	08001
20	CAP Horta	Barcelona		Spain	08032
21	CAP La Marina	Barcelona		Spain	08038
22	CAP Montilivi	Girona		Spain	17003
23	CAP Sant Pere i Sant Pau	Tarragona		Spain	43007
24	CAP Bonavista	Tarragona		Spain	43100

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Rubio-Valera, Head of Quality and Patient Safety, Parc Sanitari Sant Joan de Déu

ClinicalTrials.gov Identifier:

NCT05026775

Other Study ID Numbers:

948973

First Posted:

Aug 30, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Rubio-Valera, Head of Quality and Patient Safety, Parc Sanitari Sant Joan de Déu

Complex Intervention

Real World Data

Cardiovascular Disease

Diabetes Mellitus

Study Results

No Results Posted as of Mar 2, 2022