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

NCT05723185 | Active Not Recruiting

• 1 other identifier: PRIME
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Internal medicine model

This group of patients will be treated at the outpatient clinic which is run by internal medicine specialists

Other: Outpatient visit

Specialist model

This group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists

Other: Outpatient visit

Interventions

Outpatient visit OTHER

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

Internal medicine model; Specialist model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Pregnant women

Sponsors & Collaborators

• Rovere Querini Patrizia: lead
• ASST Fatebenefratelli Sacco: collaborator
• ASST Grande Ospedale Metropolitano Niguarda: collaborator

Study Sites (1)

San Raffaele Hospital

Milan, Italy

Location

Related Publications (3)

• 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.

  PMID: 26428441 BACKGROUND

• 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.

  PMID: 35572976 BACKGROUND

• 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.

  PMID: 36334984 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Pneumonia; Urinary Tract Infections; Fever of Unknown Origin; Venous Thrombosis; Hypertension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fever; Body Temperature Changes; Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 10, 2023
• Study Start: February 13, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

IT (1)