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| Name | Class |
|---|---|
| Parc Sanitari Sant Joan de Déu | OTHER |
| Institut Català de la Salut | OTHER |
| Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER |
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This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: IMA Intervention | Experimental | 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 | Active Comparator | Healthcare professionals from the control group prescribed medication and provided information as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Medication Adherence (IMA) Intervention | Behavioral | 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. |
| 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:
| 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:
| 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:
| 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:
| 5 months before and after recruitment |
| 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 |
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Inclusion Criteria:
Primary healthcare professionals and pharmacists who:
• Agree to participate in the pilot study.
Primary care patients who:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Cornellà de Llobregat (La Gavarra) | Cornellà de Llobregat | Barcelona | 08940 | Spain | ||
| Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36561857 | Derived | Corral-Partearroyo C, Sanchez-Vinas A, Gil-Girbau M, Penarrubia-Maria MT, Aznar-Lou I, Serrano-Blanco A, Carbonell-Duacastella C, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention. Front Public Health. 2022 Dec 6;10:1038138. doi: 10.3389/fpubh.2022.1038138. eCollection 2022. |
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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.
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Col·legi de Farmacèutics de la Província de Barcelona |
| OTHER |
| CIBER of Epidemiology and Public Health | UNKNOWN |
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PC patients: Patients from the intervention PCCs received the IMA intervention but were not aware of the group they were assigned to.
|
| Usual Care | Other | 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. |
|
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 |
| el Prat de Llobregat |
| Barcelona |
| 08820 |
| Spain |
| CAP Dr. Bartomeu Fabrés Anglada Gava 2 | Gavà | Barcelona | 08850 | Spain |
| CAP Florida Nord (CAP la Florida) | L'Hospitalet de Llobregat | Barcelona | 08905 | Spain |
| CAP Florida Sud (CAP la Florida) | L'Hospitalet de Llobregat | Barcelona | 08905 | Spain |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |