PRIME: Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
Study Details
Study Description
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.
We 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 GPs 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 PS 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Raffaele Hospital | Milan | Italy |
Sponsors and Collaborators
- Rovere Querini Patrizia
- ASST Fatebenefratelli Sacco
- ASST Grande Ospedale Metropolitano Niguarda
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. 2022 Nov 3:S0953-6205(22)00380-6. doi: 10.1016/j.ejim.2022.10.023. Online ahead of print. No abstract available.
- 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.
- PRIME