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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Body Temperature Changes Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Deep Vein Thrombosis Diabetes Mellitus Disease Attributes Embolism and Thrombosis Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fever Fever of Unknown Origin Glucose Metabolism Disorders Heart Diseases Hypertension Infections Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Thrombosis Urinary Tract Infections Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Raffaele Hospital

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient visit

Other

Patients will be seen and treated at the outpatient clinic like in the usual care

Primary outcomes

Analyse and compare the function of the two outpatient clinic models

Time frame: 6 months for each subject

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

Sponsors and collaborators

Lead sponsor

Rovere Querini Patrizia

Other

Collaborators

ASST Fatebenefratelli Sacco
ASST Grande Ospedale Metropolitano Niguarda

Registry information

Acronym: PRIME

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2025
First posted: Feb 10, 2023
Registry last updated: Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed