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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05723185
Acronym
PRIME
Enrollment
246
Registered
2023-02-10
Start date
2023-02-13
Completion date
2025-12-31
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEROutpatient visit

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

Sponsors

ASST Fatebenefratelli Sacco
CollaboratorOTHER
ASST Grande Ospedale Metropolitano Niguarda
CollaboratorOTHER
Rovere Querini Patrizia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analyse and compare the function of the two outpatient clinic models6 months for each subjectWe 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026