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

Hypertension Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723185
• Other study ID #: PRIME
• Status: Recruiting
• Start date: February 13, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2023
• Source: IRCCS San Raffaele
• Contact: Patrizia Rovere Querini
• Phone: +3902264433065
• Email: rovere.patrizia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (3)

Lead Sponsor	Collaborator
Rovere Querini Patrizia	ASST Fatebenefratelli Sacco, ASST Grande Ospedale Metropolitano Niguarda

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. 2022 Nov 3:S0953-6205(22)00380-6. doi: 10.1016/j.ejim.2022.10.023. Online ahead of print. No abstract available. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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