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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05640076
Other study ID # FEDERATION
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source Azienda Usl di Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 2831
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients followed by the Metropolitan Palliative Care Service of Bologna - Residency in Bologna Metropolitan city Exclusion Criteria: - Incomplete data - Residency outside Bologna Metropolitan City

Study Design


Related Conditions & MeSH terms


Intervention

Other:
24/7 Telephonic Palliative Care Service availability
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.

Locations

Country Name City State
Italy Azienda Unità Sanitaria Locale Bologna
Italy IRCCS - Policlinico Universitario S.Orsola - Malpighi Bologna

Sponsors (2)

Lead Sponsor Collaborator
Azienda Usl di Bologna IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Barbera 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. — View Citation

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. — View Citation

Gamblin 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. — View Citation

Thomsen 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency Department Admission rate of patients followed by the Palliative Care Service 48 months
Secondary EMS calls rate from patients followed by the Palliative Care Service 48 months
Secondary 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
24 months
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