Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence

Not Applicable

Completed

• Conditions: Adherence, Medication
• Interventions: Behavioral: Initial Medication Adherence (IMA) Intervention; Other: Usual Care

• Registration Number: NCT05094986
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.

Detailed Description

A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).

The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.

The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

Inclusion Criteria

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: IMA Intervention	Initial Medication Adherence (IMA) Intervention	General 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	Usual Care	Healthcare professionals from the control group prescribed medication and provided information as usual.

Primary Outcome Measures

Name	Time	Method
Rate of clinical registries related to diabetes mellitus II	5 months before and after recruitment	Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin; * Glomerular filtrate; * Blood glucose
Rate of clinical registries related to cardiovascular risk	5 months before and after recruitment	Rate of registries recorded five months before and after the prescription of: • REGICOR
Rate of clinical registries related to dyslipidemia	5 months before and after recruitment	Rate of registries recorded five months before and after the prescription of: * Total colesterol; * HDL cholesterol; * LDL colesterol
Rate of clinical registries related to hypertension	2 months before and after recruitment	Rate of registries recorded one to two months before and after the prescription of: * Systolic blood pressure; * Diastolic blood pressure
Rate of use of services	5 months before and after recruitment	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

Secondary Outcome Measures

Name	Time	Method
Outliers registries	5 months before and after recruitment	Number of registries with values out of their range.
Missing registries	5 months before and after recruitment	Number of registries missing.
Active diagnosis registry	5 months before and after recruitment	Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system.

Trial Locations

Locations (5)

Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada); 🇪🇸 El Prat de Llobregat, Barcelona, Spain

CAP Cornellà de Llobregat (La Gavarra); 🇪🇸 Cornellà De Llobregat, Barcelona, Spain

CAP Florida Nord (CAP la Florida); 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

CAP Dr. Bartomeu Fabrés Anglada Gava 2; 🇪🇸 Gavà, Barcelona, Spain

CAP Florida Sud (CAP la Florida); 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain