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CompletedNCT05640076Updated Jul 13, 2023

Effects of a 24/7 Palliative Care Service Integration in a Metropolitan Area on Non-oncologic Patients

An observational study in Palliative Medicine, Hospice and Palliative Care Nursing and Palliative Care, sponsored by Azienda Usl di Bologna. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Azienda Usl di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,831
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Palliative Medicine
  • Hospice and Palliative Care Nursing
  • Palliative Care

Keywords

  • Medicine, Palliative
  • Palliative Care
  • Hospice and Palliative Care Nursing
03

In context

Lead sponsor

Azienda Usl di Bologna is the lead sponsor of 40 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • Patients followed by the Metropolitan Palliative Care Service of Bologna
  • Residency in Bologna Metropolitan city

Exclusion criteria

Exclusion Criteria:

  • Incomplete data
  • Residency outside Bologna Metropolitan City
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,831 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    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

    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

    Other: 24/7 Telephonic Palliative Care Service availability

Interventions

  • Other24/7 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.

06

What researchers measure

Primary outcomes

  1. Emergency Department Admission rate of patients followed by the Palliative Care Service

    Time frame: 48 months

Secondary outcomes

  1. EMS calls rate from patients followed by the Palliative Care Service

    Time frame: 48 months

  2. 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

    Time frame: 24 months

07

Study locations

2 sites
  • Azienda Unità Sanitaria Locale
    Bologna, 40100, Italy
  • IRCCS - Policlinico Universitario S.Orsola - Malpighi
    Bologna, Italy
08

References and documents

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 12886178 ↗
  • 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. PubMed 16689410 ↗
  • 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. PubMed 33499835 ↗
  • 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. PubMed 16595540 ↗

Individual participant data

Plan to share: No — IPD will be shared if requested under appropriate motivation

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640076
Lead sponsor
Azienda Usl di Bologna
Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Apr 1, 2023
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Jul 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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