Clinical trial NCT05723185: Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
Official title: Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Diabetes Mellitus
Pneumonia
Urinary Tract Infections
Fever of Unknown Origin
Deep Vein Thrombosis
Hypertension
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: ASST Fatebenefratelli Sacco
name: ASST Grande Ospedale Metropolitano Niguarda
First posted: 2023-02-10
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Analyse and compare the function of the two outpatient clinic models
timeFrame: 6 months for each subject
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.