Clinical trial NCT05094986: Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence
Official title: Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Keywords: Pilot Study
Feasibility Study
Complex Intervention
Real-World Data
Cardiovascular Disease
Diabetes Mellitus
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Institut Català de la Salut
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Col·legi de Farmacèutics de la Província de Barcelona
name: CIBER of Epidemiology and Public Health
First posted: 2021-10-26
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of clinical registries related to diabetes mellitus II
timeFrame: 5 months before and after recruitment
measure: Rate of clinical registries related to dyslipidemia
timeFrame: 5 months before and after recruitment
measure: Rate of clinical registries related to hypertension
timeFrame: 2 months before and after recruitment
measure: Rate of clinical registries related to cardiovascular risk
timeFrame: 5 months before and after recruitment
measure: Rate of use of services
timeFrame: 5 months before and after recruitment
Secondary outcomes:
measure: Active diagnosis registry
timeFrame: 5 months before and after recruitment
measure: Missing registries
timeFrame: 5 months before and after recruitment
measure: Outliers registries
timeFrame: 5 months before and after recruitment
Other outcomes:
Locations:
city: Cornellà De Llobregat
country: Spain
facility: CAP Cornellà de Llobregat (La Gavarra)
state: Barcelona
city: El Prat de Llobregat
country: Spain
facility: Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)
state: Barcelona
city: Gavà
country: Spain
facility: CAP Dr. Bartomeu Fabrés Anglada Gava 2
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: CAP Florida Nord (CAP la Florida)
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: CAP Florida Sud (CAP la Florida)
state: Barcelona
Study officials:
References: