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

NCT05723185 — Active not recruiting, 246 participants, Rovere Querini Patrizia

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Registry	NCT05723185, acronym PRIME
Status	Active not recruiting
Study type	Observational
Enrollment	246 (Estimated)
Sponsor	Rovere Querini Patrizia (Other); collaborators: ASST Fatebenefratelli Sacco, ASST Grande Ospedale Metropolitano Niguarda
Conditions	Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Pneumonia, Urinary Tract Infections, Fever of Unknown Origin, Deep Vein Thrombosis, Hypertension
Interventions	Outpatient visit (Other)
Dates	start 2023-02-13, primary completion 2023-08-31, completion 2025-12-31 (estimated), first posted 2023-02-10, last updated 2025-06-22
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Internal medicine model		Other: Outpatient visit	This group of patients will be treated at the outpatient clinic which is run by internal medicine specialists
Specialist model		Other: Outpatient visit	This group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists

Outpatient visit (Other): Patients will be seen and treated at the outpatient clinic like in the usual care

+Outcome measures

Primary outcomes

Analyse and compare the function of the two outpatient clinic models [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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
San Raffaele Hospital	Milan	Italy

+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. PMID 26428441
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
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

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