Palliative MedicineNCT05640076
Effects of a 24/7 Palliative Care Service Integration in a Metropolitan Area on Non-oncologic Patients
An observational study of Palliative Medicine and Hospice and Palliative Care Nursing, run by Azienda Usl di Bologna at 2 sites in Italy.
Trial summary
This retrospective observational pre-post study aims to test the effects of introducing a remote telephonic consultation availability from the Palliative Care Service for a cohort of non-oncologic patients followed by the same service, their relatives, and the Emergency Medical Services (EMS) and family care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Medicine, Hospice and Palliative Care Nursing, Palliative Care
- What is being tested?
- 24/7 Telephonic Palliative Care Service availability
- How many people
- 2,831 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The population in the study is composed of the whole population of patients followed by the palliative care metropolitan service of Bologna respecting the Eligibility criteria shown
Who may be able to join
- Patients followed by the Metropolitan Palliative Care Service of Bologna
- Residency in Bologna Metropolitan city
Who cannot join
- Incomplete data
- Residency outside Bologna Metropolitan City
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Unità Sanitaria Locale
Bologna, 40100
IRCCS - Policlinico Universitario S.Orsola - Malpighi
Bologna
About this study
This retrospective observational pre-post study aims to test the effects of introducing a remote telephonic consultation availability from the Palliative Care Service for a cohort of non-oncologic patients followed by the same service, their relatives, and the Emergency Medical Services (EMS) and family care physicians taking care of them.
The main question[s] it aims to answer are:
Read more
- Does the introduction of a remote telephonic consultation availability affect the rate of ED access of non-oncologic Palliative-care followed patients during their last 90 days of life?
- Does the introduction of a remote telephonic consultation availability have an effect on the rate of EMS requests for these patients during their last 90 days of life?
- Which are the main topics of the calls to the Palliative Care Service?
Due to the emergence of COVID-19 pandemic during the study period, a parallel cohort of oncologic patients under 24/7 palliative care by the same service during both the observation periods will be used as reference.
Participants will be followed up from the date of taking-over request to the Palliative Care Service to their death or the end of the period of observation if followup began during their last 90 days of life.
Otherwise, for those being already under home palliative care at the 90th day before their death, follow up will begin at that day.
Researchers will compare two time periods to see if the introduction of a remote telephonic consultation availability has an effect on the supra-mentioned aims.
- Being tested
- 24/7 Telephonic Palliative Care Service availability
- Keywords
- Medicine, Palliative, Palliative Care, Hospice and Palliative Care Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24/7 Telephonic Palliative Care Service availabilityOther
Metropolitan Palliative Care Service-implemented 24/7 telephonic availability service for the patients, their relatives, the EMS and Primary Care physicians taking care of them.
After consultation, if the information and medical suggestions are not sufficient, an urgent ambulatory or home visit could be planned.
| Study group | Role | What they receive |
|---|---|---|
| 2018-19 - Oncologic patients under home palliative care | Oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2018 and 31/12/2019 Receives: Other: 24/7 Telephonic Palliative Care Service availability | |
| 2018-19 - Non-oncologic patients under home palliative care | Non-oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2018 and 31/12/2019 | |
| 2021-2022 - Oncologic patients under home palliative care | Oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2021 and 31/12/2022 Receives: Other: 24/7 Telephonic Palliative Care Service availability | |
| 2021-2022 - Non-Oncologic patients under home palliative care | Non-oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2021 and 31/12/2022 Receives: Other: 24/7 Telephonic Palliative Care Service availability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Admission rate of patients followed by the Palliative Care Service
Measured: 48 months
Secondary outcomes (2)
EMS calls rate from patients followed by the Palliative Care Service
Measured: 48 months
Main topics of the calls received from the Palliative Care Service after the full implementation of a 24/7 service
Classification of the topics of the calls into 5 main classes: "Clinical questions", "Caregiver Support", "Definition of care pathway", "Palliative sedation", "Other communications".
The relative frequency of each main topic will be reported
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Palliative MedicineStudies 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
- Retrospective
- Enrolment
- 2,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640076
- Sponsor's protocol ID
- FEDERATION
- Status last verified
- Jun 2023
- First submitted
- 28 Nov 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared if requested under appropriate motivation
Publications
Burge F, Lawson B, Johnston G. Family physician continuity of care and emergency department use in end-of-life cancer care. Med Care. 2003 Aug;41(8):992-1001. doi: 10.1097/00005650-200308000-00012.
PubMed 12886178Barbera L, Paszat L, Chartier C. Indicators of poor quality end-of-life cancer care in Ontario. J Palliat Care. 2006 Spring;22(1):12-7.
PubMed 16689410Gamblin V, Prod'homme C, Lecoeuvre A, Bimbai A-, Luu J, Hazard PA, Da Silva A, Villet S, Le Deley MC, Penel N. Home hospitalization for palliative cancer care: factors associated with unplanned hospital admissions and death in hospital. BMC Palliat Care. 2021 Jan 26;20(1):24. doi: 10.1186/s12904-021-00720-7.
PubMed 33499835Thomsen JL, Parner ET. Methods for analysing recurrent events in health care data. Examples from admissions in Ebeltoft Health Promotion Project. Fam Pract. 2006 Aug;23(4):407-13. doi: 10.1093/fampra/cml012. Epub 2006 Apr 4.
PubMed 16595540Valenti D, Gamberini L, Allegri D, Tartaglione M, Moggia F, Del Giudice D, Baroni R, Di Mirto CVF, Tamanti J, Rosa S, Paoletti S, Bruno L, Peterle C, Cuomo AMR, Bertini A, Giostra F, Mengoli F; Collaborators. Effects of 24/7 palliative care consultation availability on the use of emergency department and emergency medical services resources from non-oncological patients: a before-and-after observational cohort study. BMJ Support Palliat Care. 2024 Dec 19;14(e3):e2788-e2797. doi: 10.1136/spcare-2023-004412.
PubMed 37973206
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 24/7 Palliative Care Service Integration in a Metropolitan Area on Non-oncologic Patients
- ClinicalTrials.gov ID
- NCT05640076
- Acronym / sponsor ID
- FEDERATION
- Keywords
- Medicine, Palliative, Palliative Care, Hospice and Palliative Care Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,831 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Dec 2022 (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 retrospective observational pre-post study aims to test the effects of introducing a remote telephonic consultation availability from the Palliative Care Service for a cohort of non-oncologic patients followed by the same service, their relatives, and the Emergency Medical Services (EMS) and family care physicians taking care of them.
The main question[s] it aims to answer are:
- Does the introduction of a remote telephonic consultation availability affect the rate of ED access of non-oncologic Palliative-care followed patients during their last 90 days of life?
- Does the introduction of a remote telephonic consultation availability have an effect on the rate of EMS requests for these patients during their last 90 days of life?
- Which are the main topics of the calls to the Palliative Care Service?
Due to the emergence of COVID-19 pandemic during the study period, a parallel cohort of oncologic patients under 24/7 palliative care by the same service during both the observation periods will be used as reference.
Participants will be followed up from the date of taking-over request to the Palliative Care Service to their death or the end of the period of observation if followup began during their last 90 days of life.
Otherwise, for those being already under home palliative care at the 90th day before their death, follow up will begin at that day.
Researchers will compare two time periods to see if the introduction of a remote telephonic consultation availability has an effect on the supra-mentioned aims.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2018-19 - Oncologic patients under home palliative care | – | Other: 24/7 Telephonic Palliative Care Service availabilityOncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2018 and 31/12/2019 |
| 2018-19 - Non-oncologic patients under home palliative care | – | –Non-oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2018 and 31/12/2019 |
| 2021-2022 - Oncologic patients under home palliative care | – | Other: 24/7 Telephonic Palliative Care Service availabilityOncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2021 and 31/12/2022 |
| 2021-2022 - Non-Oncologic patients under home palliative care | – | Other: 24/7 Telephonic Palliative Care Service availabilityNon-oncologic patients took over from the Metropolitan Palliative Care Service and receiving home palliative care within their last 90 days of life between 1/1/2021 and 31/12/2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population in the study is composed of the whole population of patients followed by the palliative care metropolitan service of Bologna respecting the Eligibility criteria shown
Key inclusion criteria (2 listed)
- Patients followed by the Metropolitan Palliative Care Service of Bologna
- Residency in Bologna Metropolitan city
Key exclusion criteria (2 listed)
- Incomplete data
- Residency outside Bologna Metropolitan City
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 |
|---|---|---|
| 24/7 Telephonic Palliative Care Service availabilityMetropolitan Palliative Care Service-implemented 24/7 telephonic availability service for the patients, their relatives, the EMS and Primary Care physicians taking care of them. After consultation, if the information and medical suggestions are not sufficient, an urgent ambulatory or home visit could be planned. | Other | 2018-19 - Oncologic patients under home palliative care, 2021-2022 - Non-Oncologic patients under home palliative care, 2021-2022 - Oncologic patients under home palliative care |
Primary outcome
Emergency Department Admission rate of patients followed by the Palliative Care Service
Time frame: 48 months
2 secondary outcomes
EMS calls rate from patients followed by the Palliative Care Service
Time frame: 48 months
Main topics of the calls received from the Palliative Care Service after the full implementation of a 24/7 service
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 12886178Burge F, Lawson B, Johnston G. Family physician continuity of care and emergency department use in end-of-life cancer care. Med Care. 2003 Aug;41(8):992-1001. doi: 10.1097/00005650-200308000-00012.
- Background: PubMed 16689410Barbera L, Paszat L, Chartier C. Indicators of poor quality end-of-life cancer care in Ontario. J Palliat Care. 2006 Spring;22(1):12-7.
- Background: PubMed 33499835Gamblin V, Prod'homme C, Lecoeuvre A, Bimbai A-, Luu J, Hazard PA, Da Silva A, Villet S, Le Deley MC, Penel N. Home hospitalization for palliative cancer care: factors associated with unplanned hospital admissions and death in hospital. BMC Palliat Care. 2021 Jan 26;20(1):24. doi: 10.1186/s12904-021-00720-7.
- Background: PubMed 16595540Thomsen JL, Parner ET. Methods for analysing recurrent events in health care data. Examples from admissions in Ebeltoft Health Promotion Project. Fam Pract. 2006 Aug;23(4):407-13. doi: 10.1093/fampra/cml012. Epub 2006 Apr 4.
- Derived from this study: PubMed 37973206Valenti D, Gamberini L, Allegri D, Tartaglione M, Moggia F, Del Giudice D, Baroni R, Di Mirto CVF, Tamanti J, Rosa S, Paoletti S, Bruno L, Peterle C, Cuomo AMR, Bertini A, Giostra F, Mengoli F; Collaborators. Effects of 24/7 palliative care consultation availability on the use of emergency department and emergency medical services resources from non-oncological patients: a before-and-after observational cohort study. BMJ Support Palliat Care. 2024 Dec 19;14(e3):e2788-e2797. doi: 10.1136/spcare-2023-004412.
- Individual participant dataSharing planned: No. IPD will be shared if requested under appropriate motivation
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Medicine and Hospice and Palliative Care Nursing, run by Azienda Usl di Bologna at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emergency Department Admission rate of patients followed by the Palliative Care Service (time frame: 48 months). 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 NCT05640076, which also lists 5 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 13 Jul 2023.