Identification of Elderly Patients in Need of Palliative Care by Family Physicians (GerPal-ID)

October 31, 2022 updated by: Carlos Seiça Cardoso, University of Beira Interior

Identification of Elderly Patients in Need of Palliative Care by Family Physicians - the Role of Palliative Care Training and the Use of a Standardized Tool (GerPal_ID). A Two-phase Protocol: Randomized Trial and Prevalence Study

In the last decades, the number of people living with chronic diseases had increased, mainly due to the aging of the population. Such chronic, progressive, life threatening and burdening diseases, play an important role in this new era of palliative care.

Despite the growing scientific and social interest in palliative care, there is still a delay in the identification of patients with palliative care needs. This leads to a late integration in a palliative care network and consequent deprivation of the major advantages of an early and progressive integration.

The aim of this study is to evaluate the role of palliative care training and the use of a structured tool, in the identification of the elderly population in need of palliative care by family physicians. And also to conduct a prevalence study to further the knowledge about how many elder people in primary care have the need of a palliative care approach.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study consists of two phases:

  1. Randomized trial with General Practitioners (GP) to determine the role of two different training programs and a structured tool in the identification of geriatric patients with palliative care needs.
  2. Cross-sectional, analytical study of the prevalence and patterns of geriatric patients with Palliative Care (PC) needs, managed in primary care in Portugal's Center Healthcare Administrative Region.

Study Type

Interventional

Phase

  • Not Applicable

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

  • Portugal
      • Coimbra, Portugal, 3025
        • Center Healthcare Administrative Region

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GPs (fellows and specialists) from Center Healthcare Administrative Region

Exclusion Criteria:

  • Previous palliative care training.
  • Refuse to participate

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
GPs (fellows and specialists) from Center Healthcare Administrative Region that will be given no intervention
Experimental: Identification tool group
GPs (fellows and specialists) from Center Healthcare Administrative Region that will receive access to the Identification tool Supportive and Palliative Care Indicators Tool (SPICT-PT) with a brief training on how to use it.
Other: Palliative care training
Intervention will consist on providing different types of palliative care training to identify the most accurate on improving GPs' identification of palliative care patients skills
Experimental: Standard Palliative Care Training
GPs (fellows and specialists) from Center Healthcare Administrative Region that will receive palliative care training according to the Center Healthcare Administrative Region standard model of training.
Other: Palliative care training
Intervention will consist on providing different types of palliative care training to identify the most accurate on improving GPs' identification of palliative care patients skills
Experimental: Clinical cases based Palliative Care Training
GPs (fellows and specialists) from Center Healthcare Administrative Region that will receive palliative care training using a clinical cases based model.
Other: Palliative care training
Intervention will consist on providing different types of palliative care training to identify the most accurate on improving GPs' identification of palliative care patients skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPs' rate of identification of patients with palliative care needs
Time Frame: 2 weeks

Each GP will have to identify, before each intervention, from a set of fictitious clinical cases constructed for this purpose, which patients need palliative care. After each intervention, they will re-evaluate the same clinical cases and will be asked to identify again which patients need palliative care.

Each intervention will be measured according to the identification accuracy.
2 weeks
Prevalence geriatric patients with palliative care needs
Time Frame: 6 months
Number (% of patients) of geriatric patients, managed in primary care in Center Healthcare Administrative Region, with palliative care needs.
6 months
Sociodemographic characteristics of geriatric patients with palliative care needs
Time Frame: 6 months
Age (in years), sex (male or female), marital status (single, married, divorced, widow, marriage) and job of geriatric patients, managed in primary care in Center Healthcare Administrative Region, with palliative care needs.
6 months
Clinical characteristics of geriatric patients with palliative care need
Time Frame: 6 months
Main diseases, main symptoms, number of contacts with GP/year of geriatric patients, managed in primary care in Center Healthcare Administrative Region, with palliative care needs.
6 months
Complexity of geriatric patients with palliative care need
Time Frame: 6 months
Complexity of of geriatric patients, managed in primary care in Center Healthcare Administrative Region, with palliative care needs, evaluated using ICD-Pal tool
6 months

Collaborators and Investigators

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

Sponsor

University of Beira Interior

Investigators

  • Principal Investigator: Carlos Seiça Cardoso, MD, Faculty of Health Science - University of Beira Interior

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)

November 1, 2019

Primary Completion (Anticipated)

December 29, 2020

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE-UBI-Pj-2019-023:ID1244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from the Ethics Committee of the Faculty of Health Sciences, University of Beira Interior. Study results will be published in peer-reviewed journals and presented at national and international conferences.

IPD Sharing Time Frame

Between June 2019 and October 2020

IPD Sharing Access Criteria

A descriptive analysis will be performed to all study variables, namely the number of valid observations, mean, standard deviation, median and range for quantitative variables and absolute and relative frequencies for qualitative variables whenever it will be considered adequate.

According to previous reports , patients with palliative care needs will be defined as ≥2 positive general indicators or ≥1 positive disease-specific indicators in the SPICT.

Comparisons between two or more independent groups of quantitative variables will be performed using Pearson's Chi2 test or Fisher's exact test, analysis of variance (ANOVA) or non-parametric Kruskal-Wallis test. All tests will be two-sided using a significance level of 0.05. Statistical analysis will be conducted using Statistical Package for the Social Sciences (SPSS) V.24.0 or higher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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