Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study

Study Overview
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Brief Summary
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This is a multicentric, prospective, observational study with two cohorts and adjunctive procedure. It aims at collecting and analyzing data about the function of an innovative hospital-territory integration health service for the management of patients with intermediate urgency, or emergency department white codes. This service, activated in the participating centers, will be provided in two alternative modalities, one so-called dual specialty (cardiology and diabetes specialist outpatient clinic) and a second one more focused on the figure of the specialist in Internal Medicine. The investigators will monitor the population treated in these centers (presenting complaint, medical history, clinical-radiological data, performed therapies and overall health path) and the degree of satisfaction of the General Practitioners who sent their patients there and the degree of satisfaction of the patients themselves. The data collected will also be used to evaluate the effectiveness of the outpatient clinics in terms of reducing improper admissions to the Emergency Departments and hospitalizations. The two modes of service delivery will be compared. This is an 18-month study, sponsored by our Scientific Directorate and carried out on a nonprofit basis. The study will enroll 246 patients and 30 healthy volunteer General Practitioners. The clinical trial will be conducted in accordance with Good Clinical Practice standards.

Official Title
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Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study

Conditions
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Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Pneumonia, Urinary Tract Infections, Fever of Unknown Origin, Deep Vein Thrombosis, Hypertension

Intervention / Treatment
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* Other: Outpatient visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients sent by General Practitioners for outpatient evaluation in the two models Patients able to read and sign the informed consent Patients able to read and fill the questionnaire Exclusion Criteria: - Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Internal medicine model<br>This group of patients will be treated at the outpatient clinic which is run by internal medicine specialists | Other: Outpatient visit<br>* Patients will be seen and treated at the outpatient clinic like in the usual care<br>|
| Specialist model<br>This group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists | Other: Outpatient visit<br>* Patients will be seen and treated at the outpatient clinic like in the usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse and compare the function of the two outpatient clinic models | We will gather data describing the different patients treated at the two outpatient clinics; moreover, we will describe the timing, efficiency and effectiveness of the interventions and compare the two models; lastly, feedback from patients and general practitioners will be gathered through questionnaires | 6 months for each subject |