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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Pneumonia; Hypertension; Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Urinary Tract Infections; Deep Vein Thrombosis; Fever of Unknown Origin
• Intervention / Treatment: Other: Outpatient visit

• Study Type: Observational
• Enrollment (Estimated): 246

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated at the outpatient clinics (one cardio-diabetes specialty managed, one internist managed) with direct access for intermediate emergency management. For San Raffaele Hospital, patients will be those treated at the strategic project of hospital-territory embedding at Ville Turro (Milan). General practitioners (GPs) in the Milan Metropolitan Area will be recruited for questionnaire filling and patients referral.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Internal medicine model; This group of patients will be treated at the outpatient clinic which is run by internal medicine specialists	Other: Outpatient visit; Patients will be seen and treated at the outpatient clinic like in the usual care
Specialist model; This group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists	Other: Outpatient visit; Patients will be seen and treated at the outpatient clinic like in the usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rovere Querini Patrizia
• Collaborators: ASST Fatebenefratelli Sacco; ASST Grande Ospedale Metropolitano Niguarda

Publications and helpful links

General Publications

• Sundmacher L, Fischbach D, Schuettig W, Naumann C, Augustin U, Faisst C. Which hospitalisations are ambulatory care-sensitive, to what degree, and how could the rates be reduced? Results of a group consensus study in Germany. Health Policy. 2015 Nov;119(11):1415-23. doi: 10.1016/j.healthpol.2015.08.007. Epub 2015 Sep 2.
• De Lorenzo R, Montagna M, Bossi E, Vitali G, Taino A, Cilla M, Pata G, Lazorova L, Pesenti R, Pomaranzi C, Bussolari C, Martinenghi S, Bordonaro N, Di Napoli D, Rizzardini G, Cogliati C, Morici N, Rovere-Querini P. A Pilot Study of the Efficacy and Economical Sustainability of Acute Coronavirus Disease 2019 Patient Management in an Outpatient Setting. Front Med (Lausanne). 2022 Apr 27;9:892962. doi: 10.3389/fmed.2022.892962. eCollection 2022.
• Montagna M, Morici N, Tritschler T, Rovere Querini P. Fostering the intersection between primary care and hospital: hints from a survey and the PRIME (PRIMary care-hospital Embedding) project. Eur J Intern Med. 2023 Mar;109:131-134. doi: 10.1016/j.ejim.2022.10.023. Epub 2022 Nov 3. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Infections; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Body Temperature Changes; Fever; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Thrombosis; Venous Thrombosis; Urinary Tract Infections; Fever of Unknown Origin
• Other Study ID Numbers: PRIME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No