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

July 12, 2023 updated by: Azienda Usl di Bologna

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2831

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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 - 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

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.
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Emergency Department Admission rate of patients followed by the Palliative Care Service
Time Frame: 48 months
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMS calls rate from patients followed by the Palliative Care Service
Time Frame: 48 months
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FEDERATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared if requested under appropriate motivation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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