NCT05640076

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

November 28, 2022

Last Update Submit

July 12, 2023

Conditions

Palliative MedicineHospice and Palliative Care NursingPalliative Care

Keywords

Medicine, PalliativePalliative CareHospice and Palliative Care Nursing

Outcome Measures

Primary Outcomes (1)

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

    48 months

Secondary Outcomes (2)

  • EMS calls rate from patients followed by the Palliative Care Service

    48 months

  • Main topics of the calls received from the Palliative Care Service after the full implementation of a 24/7 service

    24 months

Study Arms (4)

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

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.

2018-19 - Oncologic patients under home palliative care2021-2022 - Non-Oncologic patients under home palliative care2021-2022 - Oncologic patients under home palliative care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Incomplete data
  • Residency outside Bologna Metropolitan City

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

Location

IRCCS - Policlinico Universitario S.Orsola - Malpighi

Bologna, Italy

Location

Related Publications (5)

  • 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.

    PMID: 12886178BACKGROUND

  • 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.

    PMID: 16689410BACKGROUND

  • 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.

    PMID: 33499835BACKGROUND

  • 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.

    PMID: 16595540BACKGROUND

  • Valenti 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.

    PMID: 37973206DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

July 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

IPD will be shared if requested under appropriate motivation

Locations

IT(2)