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

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

Study Overview

• Status: Completed
• Conditions: Adherence, Medication
• Intervention / Treatment: Behavioral: Initial Medication Adherence (IMA) Intervention; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 605
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Cornellà De Llobregat, Barcelona, Spain, 08940
      • CAP Cornellà de Llobregat (La Gavarra)
    • El Prat de Llobregat, Barcelona, Spain, 08820
      • Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)
    • Gavà, Barcelona, Spain, 08850
      • CAP Dr. Bartomeu Fabrés Anglada Gava 2
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08905
      • CAP Florida Nord (CAP la Florida)
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08905
      • CAP Florida Sud (CAP la Florida)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: 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).	Behavioral: Initial Medication Adherence (IMA) Intervention; 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.
Active Comparator: Control group; Healthcare professionals from the control group prescribed medication and provided information as usual.	Other: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active diagnosis registry	Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system.	5 months before and after recruitment
Missing registries	Number of registries missing.	5 months before and after recruitment
Outliers registries	Number of registries with values out of their range.	5 months before and 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; Col·legi de Farmacèutics de la Província de Barcelona; CIBER of Epidemiology and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Cardiovascular Disease; Feasibility Study; Pilot Study; Complex Intervention; Real-World Data
• Other Study ID Numbers: 19/198-P

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 in Catalonia.

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