Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence
Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care
1 other identifier
interventional
605
1 country
5
Brief Summary
This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
5 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
Study Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedFebruary 18, 2022
February 1, 2022
3 months
October 8, 2021
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Rate of clinical registries related to diabetes mellitus II
Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin * Glomerular filtrate * Blood glucose
5 months before and after recruitment
Rate of clinical registries related to dyslipidemia
Rate of registries recorded five months before and after the prescription of: * Total colesterol * HDL cholesterol * LDL colesterol
5 months before and after recruitment
Rate of clinical registries related to hypertension
Rate of registries recorded one to two months before and after the prescription of: * Systolic blood pressure * Diastolic blood pressure
2 months before and after recruitment
Rate of clinical registries related to cardiovascular risk
Rate of registries recorded five months before and after the prescription of: • REGICOR
5 months before and after recruitment
Rate of use of services
Rate of use of services recorded five months before and after the prescription of: * Visits to primary care (nurse, GP) * Referrals to secondary care * Productivity losses (sick leave days) * Outpatient diagnostic tests
5 months before and after recruitment
Secondary Outcomes (3)
Active diagnosis registry
5 months before and after recruitment
Missing registries
5 months before and after recruitment
Outliers registries
5 months before and after recruitment
Study Arms (2)
Intervention group: IMA Intervention
EXPERIMENTALGeneral practitioners (GP) applied the IMA intervention to all patients receiving a new prescription for pharmacological treatments of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists offered information support in line with the information provided by the GP. Professionals had the intervention support tools available (leaflets, website and dispensing alert in community pharmacies).
Control group
ACTIVE COMPARATORHealthcare professionals from the control group prescribed medication and provided information as usual.
Interventions
The IMA intervention promotes health literacy and patient participation in the decision-making process during the recommendation and prescription of a new drug for the management of cardiovascular disease and diabetes. The IMA intervention has four main components: 1. Training for healthcare professionals (GPs, nurses, and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; 2. Intervention support tools; decision aids (leaflets and website) and implementation tools (dispensing alert in community pharmacies when dispensing insulins and antiplatelet drugs); 3. Shared decision-making process during the GP's consultation; and 4. Information support provided by the nurses and community pharmacists that use the intervention decision aids to explore the patients' doubts and standardise the discourse between primary healthcare professionals.
Patients received the usual care when being prescribed a new prescription for treatments of cardiovascular disease or diabetes. Nurses and community pharmacists were asked to also provide usual care to those patients. Community pharmacists from the control group had the dispensing alert available when dispensing insulins and antiplatelet drugs.
Eligibility Criteria
You may qualify if:
- Primary healthcare professionals and pharmacists who:
- Agree to participate in the pilot study.
- Primary care patients who:
- Are prescribed a new treatment of cardiovascular disease o diabetes by a GP 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
- Parc Sanitari Sant Joan de Déucollaborator
- Institut Català de la Salutcollaborator
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurinacollaborator
- Col·legi de Farmacèutics de la Província de Barcelonacollaborator
- CIBER of Epidemiology and Public Healthcollaborator
Study Sites (5)
CAP Cornellà de Llobregat (La Gavarra)
Cornellà de Llobregat, Barcelona, 08940, Spain
Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)
el Prat de Llobregat, Barcelona, 08820, Spain
CAP Dr. Bartomeu Fabrés Anglada Gava 2
Gavà, Barcelona, 08850, Spain
CAP Florida Nord (CAP la Florida)
L'Hospitalet de Llobregat, Barcelona, 08905, Spain
CAP Florida Sud (CAP la Florida)
L'Hospitalet de Llobregat, Barcelona, 08905, Spain
Related Publications (1)
Corral-Partearroyo C, Sanchez-Vinas A, Gil-Girbau M, Penarrubia-Maria MT, Aznar-Lou I, Serrano-Blanco A, Carbonell-Duacastella C, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention. Front Public Health. 2022 Dec 6;10:1038138. doi: 10.3389/fpubh.2022.1038138. eCollection 2022.
PMID: 36561857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- PC patients: Patients from the intervention PCCs received the IMA intervention but were not aware of the group they were assigned to.
- 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
October 8, 2021
First Posted
October 26, 2021
Study Start
November 1, 2020
Primary Completion
January 30, 2021
Study Completion
June 30, 2021
Last Updated
February 18, 2022
Record last verified: 2022-02
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 in Catalonia. Consequently, meta-data cannot be published by the authors nor data can be identified with a DOI.