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

Adherence, Medication Clinical Trial

Official title:

Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094986
• Other study ID #: 19/198-P
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: June 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication

Intervention

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.

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.

Locations

Country	Name	City	State
Spain	CAP Cornellà de Llobregat (La Gavarra)	Cornellà De Llobregat	Barcelona
Spain	Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)	El Prat de Llobregat	Barcelona
Spain	CAP Dr. Bartomeu Fabrés Anglada Gava 2	Gavà	Barcelona
Spain	CAP Florida Nord (CAP la Florida)	L'Hospitalet De Llobregat	Barcelona
Spain	CAP Florida Sud (CAP la Florida)	L'Hospitalet de Llobregat	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	CIBER of Epidemiology and Public Health, Col·legi de Farmacèutics de la Província de Barcelona, Institut Català de la Salut, Jordi Gol i Gurina Foundation, Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Missing registries	Number of registries missing.	5 months before and after recruitment
Secondary	Outliers registries	Number of registries with values out of their range.	5 months before and after recruitment