Identification of Elderly Patients in Need of Palliative Care by Family Physicians

NCT04010136 | Withdrawn DMC

• 1 other identifier: CE-UBI-Pj-2019-023:ID1244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palliative Care; Primary Health Care; Geriatrics

Keywords

Palliative care; Primary health care; Palliative care training; Prevalence; Geriatrics

Outcome Measures

Primary Outcomes (5)

• GPs' rate of identification of patients with palliative care needs

  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

  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

  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

  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

  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

Study Arms (4)

Control group

NO INTERVENTION

GPs (fellows and specialists) from Center Healthcare Administrative Region that will be given no intervention

Identification tool group

EXPERIMENTAL

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

Standard Palliative Care Training

EXPERIMENTAL

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

Clinical cases based Palliative Care Training

EXPERIMENTAL

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

Interventions

Palliative care training OTHER

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

Clinical cases based Palliative Care Training; Identification tool group; Standard Palliative Care Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous palliative care training.
• Refuse to participate

Sponsors & Collaborators

• University of Beira Interior: lead

Study Sites (1)

Center Healthcare Administrative Region

Coimbra, 3025, Portugal

Location

Related Publications (19)

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  BACKGROUND

• Martin Rosello ́ ML, Fernandez Lopez A, Sanz-Amores R, et al. Instrument Diagnosing Complexity in Palliative Care, IDC-Pal. Junta Andaluc ́ıa Cons Igualdad, Salud y Pol ́ıticas Soc [Internet] 2014. Available from: http://www.juntadeandalucia.es/salud/export/sites/csalud/galerias/documentos/ p_3_p_3_procesos_asistenciales_integrados/cuidados_paliativos/idc_pal_ 2014.pdf. [Accessed 6 April 2019].

  BACKGROUND

Study Officials

• Carlos Seiça Cardoso, MD

  Faculty of Health Science - University of Beira Interior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The GPs (fellows and specialists) from Center Healthcare Administrative Region will be invited to take part in this trial. The invitations will be conducted with the help of the Center Healthcare Administrative Region and by spreading the invitation in some general practice professionals' mailing lists and online platforms. First, GPs will be contacted and those who accept to participate will be randomized into one of the four-harm study groups - 1. Control Group, 2. Identification tool group, 3. Standard PC training, 4 - Clinical cases based PC training. The accuracy on the identification before and after intervention will be compared within each group and between the four groups using a clinical record based identification tool (CCB-PCId). A PC expert panel will build a tool, clinical record based, to evaluate the accuracy of palliative care needs identification.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 8, 2019
• Study Start: November 1, 2019
• Primary Completion: December 29, 2020
• Study Completion: December 30, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Between June 2019 and October 2020
• 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.

Locations

PT (1)