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

Sponsor

Fundació Sant Joan de Déu (Other)

Overall Status

Completed

CT.gov ID

NCT05094986

Collaborator

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

605

Enrollment

Locations

Arms

7.9

Actual Duration (Months)

121

Patients Per Site

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adherence, Medication	Behavioral: Initial Medication Adherence (IMA) Intervention Other: Usual Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

605 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

PC patients: Patients from the intervention PCCs received the IMA intervention but were not aware of the group they were assigned to.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Jan 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 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 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 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

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.
Missing registries [5 months before and after recruitment]
Number of registries missing.
Outliers registries [5 months before and after recruitment]
Number of registries with values out of their range.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAP Cornellà de Llobregat (La Gavarra)	Cornellà De Llobregat	Barcelona	Spain	08940
2	Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)	El Prat de Llobregat	Barcelona	Spain	08820
3	CAP Dr. Bartomeu Fabrés Anglada Gava 2	Gavà	Barcelona	Spain	08850
4	CAP Florida Nord (CAP la Florida)	L'Hospitalet De Llobregat	Barcelona	Spain	08905
5	CAP Florida Sud (CAP la Florida)	L'Hospitalet de Llobregat	Barcelona	Spain	08905