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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010136
Recruitment Status : Suspended (We were not able to recruit participants to enrol the study. As it was not able, the investigation team decided not to proced.)
First Posted : July 8, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Seiça Cardoso, University of Beira Interior

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.


Condition or disease Intervention/treatment Phase
Palliative Care Primary Health Care Geriatrics Other: Palliative care training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




Primary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous palliative care training.
  • Refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010136


Locations
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Portugal
Center Healthcare Administrative Region
Coimbra, Portugal, 3025
Sponsors and Collaborators
University of Beira Interior
Investigators
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Principal Investigator: Carlos Seiça Cardoso, MD Faculty of Health Science - University of Beira Interior
  Study Documents (Full-Text)

Documents provided by Carlos Seiça Cardoso, University of Beira Interior:
Study Protocol  [PDF] June 10, 2019

Publications:
K, T. Using prognostic indicator guidance to plan care for final stages of life. Prim. Heal. Care 6, 25-28 (2010).
Pimentel, J. P., Durval, M., Araújo, F. O. & Guerreiro, A. C. ACeS Baixo Mondego. (2017).
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].

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Responsible Party: Carlos Seiça Cardoso, Principal Investigator, University of Beira Interior
ClinicalTrials.gov Identifier: NCT04010136    
Other Study ID Numbers: CE-UBI-Pj-2019-023:ID1244
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Seiça Cardoso, University of Beira Interior:
Palliative care
Primary health care
Palliative care training
Prevalence
Geriatrics