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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
- ClinicalTrials.gov ID
- NCT05723185
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Pneumonia, Urinary Tract Infections, Fever of Unknown Origin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Rovere Querini PatriziaUniversity, hospital or other
- Collaborators
- ASST Fatebenefratelli Sacco, ASST Grande Ospedale Metropolitano Niguarda
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal medicine model | – | Other: Outpatient visitThis group of patients will be treated at the outpatient clinic which is run by internal medicine specialists |
| Specialist model | – | Other: Outpatient visitThis group of patients will be treated at the outpatient clinic which is run by cardiologists and/or diabetologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient visitPatients will be seen and treated at the outpatient clinic like in the usual care | Other | Internal medicine model, Specialist model |
Primary outcome
Analyse and compare the function of the two outpatient clinic models
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 26428441Sundmacher 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.
- Background: PubMed 35572976De 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.
- Background: PubMed 36334984Montagna 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by Rovere Querini Patrizia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse and compare the function of the two outpatient clinic models (time frame: 6 months for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723185, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.