Heart FailurePRIMENCT05723185
Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by Rovere Querini Patrizia at 1 site in Italy.
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."… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus
- What is being tested?
- Outpatient visit
- How many people
- 246 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2023to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Pneumonia, Urinary Tract Infections, Fever of Unknown Origin
- Being tested
- Outpatient visit
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Pneumonia, Urinary Tract Infections, Fever of Unknown Origin, Venous Thrombosis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient visitOther
Patients will be seen and treated at the outpatient clinic like in the usual care
| Study group | Role | What they receive |
|---|---|---|
| Internal medicine model | This group of patients will be treated at the outpatient clinic which is run by internal medicine specialists Receives: Other: Outpatient visit | |
| Specialist model | This group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists Receives: Other: Outpatient visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start13 Feb 2023
- Primary completion31 Aug 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Rovere Querini Patrizia
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Fatebenefratelli Sacco, ASST Grande Ospedale Metropolitano Niguarda
- Responsible party
- Sponsor-investigator, Rovere Querini Patrizia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723185
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26428441De 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.
PubMed 35572976Montagna 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.
PubMed 36334984