New Patient Support Program in Type 2 Diabetes

Study Overview
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Brief Summary
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Non-profit observational study on the role of the community pharmacist and the pharmacy of services in the case management of the diabetic patient

Detailed Description
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Over the last few years, the Italian National Health Service has witnessed numerous and substantial changes, even more evident if one looks at the workload that this system is called to face when it comes to chronic diseases. In fact, while the progress of science has led to better outcomes in the treatment of acute diseases resulting in an increase in the average age of the population and an increase in the number of people suffering from chronic diseases, even multiple, on the other the changed socio-economic conditions activities have led to an increase in the number of elderly and socially fragile individuals. It takes very little to understand that these epidemiological and socio-sanitary mutations pose a serious threat to the stability of the investigator's health system. To meet these new needs, the different countries of the world are analyzing and adopting various models of chronic disease management. Even if with different methodologies, all the models developed so far put the patient at the center of attention, in its uniqueness and with its needs, and propose to provide the latter with complete assistance, through the integration of health and social services. In this scenario, also the role of pharmacist, historically linked to the dispensation of drugs upon presentation of a medical prescription and to a final control action to ensure a delivery of medicines in total safety, over time has evolved. In order to carry on this evolution, the pharmacist has been asked for new skills, to realize what has been defined as the pharmacy of services, through which the pharmacist is recognized the possibility of becoming a strategic figure to meet the changed needs of the population on the one hand and the Italian National Health System on the other and to support the latter in the transition from a waiting medicine to an initiative medicine. Diabetic disease and the resulting chronic complications, today, have a very significant impact on patients and their families, on morbidity and mortality, as well as having a strong economic impact on the health system. Despite this, most of the patients do not carry out what is foreseen by their diagnostic therapeutic assistance path (PDTA) due to several reasons such as long waiting times, the need to move to undergo examinations, which is not so easy for young people of working age as well as older people, lack of homogeneity in access to care and in the provision of services and more. The community pharmacist, therefore, represents, for the position in which it is located within the Italian National Health Service, a potential not yet considered. In fact, it could take on the role of case manager (a professional who manages one or more cases entrusted to him according to a pre-established path, such as PDTA, in a defined space-time context) of the patient suffering from type 2 diabetes mellitus due to the capillarity territory, to the hourly availability superior to any other territorial health structure, to the health skills in its possession and to what it can offer in terms of services within the so-called pharmacy of service. In this scenario, the pharmacist would not replace any of the other actors already present in the multidisciplinary care team but would integrate in the same and, moreover, being already an agreement with the Italian National Health Service, the conferral of this role would not cause a excessive increase in costs, such as that resulting from the hiring of new staff to achieve the same objectives.

Official Title
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The Community Pharmacist and the Case Management of Diabetic Patient - No Profit Observational Study on the Role of the Community Pharmacist and the Pharmacy of the Services in the Diabetic Patient Case Management

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Follow up


Participation Criteria
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Eligibility Criteria
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Criteria Inclusion: age> 18 years, patients with type 2 diabetes mellitus diagnosis; able to express consent to the study. Exclusion Criteria: - Nobody
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group study<br>Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria). | Other: Follow up<br>* like group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Adherence to the PDTA | Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of pharmacy of service. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waiting Time | variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days) | 365 days | 
| Levels of Arterial Pressure | variation of arterial pressure (Systolic, Diastolic) (mmHg) | 12 months | 
| Levels of HbA1c | variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy | 12 months | 
| Levels of LDL-cholesterol | variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy | 12 months | 
| Economic Impact | Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the pharmacy of service (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, terapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service, fundus camera, ecg, local pharmacist, general physician