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

NCT ID: NCT04010136

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Palliative Care Primary Health Care Geriatrics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Palliative care training

Intervention Type 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

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.

Group Type EXPERIMENTAL

Palliative care training

Intervention Type 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

GPs (fellows and specialists) from Center Healthcare Administrative Region that will receive palliative care training using a clinical cases based model.

Group Type EXPERIMENTAL

Palliative care training

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Previous palliative care training.
* Refuse to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Beira Interior

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carlos Seiça Cardoso

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos Seiça Cardoso, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Health Science - University of Beira Interior

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center Healthcare Administrative Region

Coimbra, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

Prince MJ, Wu F, Guo Y, Gutierrez Robledo LM, O'Donnell M, Sullivan R, Yusuf S. The burden of disease in older people and implications for health policy and practice. Lancet. 2015 Feb 7;385(9967):549-62. doi: 10.1016/S0140-6736(14)61347-7. Epub 2014 Nov 6.

Reference Type BACKGROUND
PMID: 25468153 (View on PubMed)

Murray SA, Firth A, Schneider N, Van den Eynden B, Gomez-Batiste X, Brogaard T, Villanueva T, Abela J, Eychmuller S, Mitchell G, Downing J, Sallnow L, van Rijswijk E, Barnard A, Lynch M, Fogen F, Moine S. Promoting palliative care in the community: production of the primary palliative care toolkit by the European Association of Palliative Care Taskforce in primary palliative care. Palliat Med. 2015 Feb;29(2):101-11. doi: 10.1177/0269216314545006. Epub 2014 Nov 13.

Reference Type BACKGROUND
PMID: 25395577 (View on PubMed)

Mitchell GK. How well do general practitioners deliver palliative care? A systematic review. Palliat Med. 2002 Nov;16(6):457-64. doi: 10.1191/0269216302pm573oa.

Reference Type BACKGROUND
PMID: 12465692 (View on PubMed)

McWhinney IR, Stewart MA. Home care of dying patients. Family physicians' experience with a palliative care support team. Can Fam Physician. 1994 Feb;40:240-6.

Reference Type BACKGROUND
PMID: 7510562 (View on PubMed)

Morrison RS, Dietrich J, Ladwig S, Quill T, Sacco J, Tangeman J, Meier DE. Palliative care consultation teams cut hospital costs for Medicaid beneficiaries. Health Aff (Millwood). 2011 Mar;30(3):454-63. doi: 10.1377/hlthaff.2010.0929.

Reference Type BACKGROUND
PMID: 21383364 (View on PubMed)

Hall S, Kolliakou A, Petkova H, Froggatt K, Higginson IJ. Interventions for improving palliative care for older people living in nursing care homes. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD007132. doi: 10.1002/14651858.CD007132.pub2.

Reference Type BACKGROUND
PMID: 21412898 (View on PubMed)

De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. General practitioners' perspectives on the avoidability of hospitalizations at the end of life: A mixed-method study. Palliat Med. 2014 Jul;28(7):949-958. doi: 10.1177/0269216314528742. Epub 2014 Apr 2.

Reference Type BACKGROUND
PMID: 24694377 (View on PubMed)

Beernaert K, Deliens L, De Vleminck A, Devroey D, Pardon K, Van den Block L, Cohen J. Is There a Need for Early Palliative Care in Patients With Life-Limiting Illnesses? Interview Study With Patients About Experienced Care Needs From Diagnosis Onward. Am J Hosp Palliat Care. 2016 Jun;33(5):489-97. doi: 10.1177/1049909115577352. Epub 2015 Apr 7.

Reference Type BACKGROUND
PMID: 25852203 (View on PubMed)

K, T. Using prognostic indicator guidance to plan care for final stages of life. Prim. Heal. Care 6, 25-28 (2010).

Reference Type BACKGROUND

Abarshi EA, Echteld MA, Van den Block L, Donker GA, Deliens L, Onwuteaka-Philipsen BD. Recognising patients who will die in the near future: a nationwide study via the Dutch Sentinel Network of GPs. Br J Gen Pract. 2011 Jun;61(587):e371-8. doi: 10.3399/bjgp11X578052.

Reference Type BACKGROUND
PMID: 21801517 (View on PubMed)

Maas EA, Murray SA, Engels Y, Campbell C. What tools are available to identify patients with palliative care needs in primary care: a systematic literature review and survey of European practice. BMJ Support Palliat Care. 2013 Dec;3(4):444-51. doi: 10.1136/bmjspcare-2013-000527.

Reference Type BACKGROUND
PMID: 24950525 (View on PubMed)

Walsh RI, Mitchell G, Francis L, van Driel ML. What Diagnostic Tools Exist for the Early Identification of Palliative Care Patients in General Practice? A systematic review. J Palliat Care. 2015;31(2):118-23. doi: 10.1177/082585971503100208. No abstract available.

Reference Type BACKGROUND
PMID: 26201214 (View on PubMed)

Hamano J, Oishi A, Kizawa Y. Prevalence and Characteristics of Patients Being at Risk of Deteriorating and Dying in Primary Care. J Pain Symptom Manage. 2019 Feb;57(2):266-272.e1. doi: 10.1016/j.jpainsymman.2018.11.006. Epub 2018 Nov 15.

Reference Type BACKGROUND
PMID: 30447382 (View on PubMed)

Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Espinosa J, Constante C, Mitchell GK. Prevalence and characteristics of patients with advanced chronic conditions in need of palliative care in the general population: a cross-sectional study. Palliat Med. 2014 Apr;28(4):302-11. doi: 10.1177/0269216313518266. Epub 2014 Jan 8.

Reference Type BACKGROUND
PMID: 24403380 (View on PubMed)

Highet G, Crawford D, Murray SA, Boyd K. Development and evaluation of the Supportive and Palliative Care Indicators Tool (SPICT): a mixed-methods study. BMJ Support Palliat Care. 2014 Sep;4(3):285-90. doi: 10.1136/bmjspcare-2013-000488. Epub 2013 Jul 25.

Reference Type BACKGROUND
PMID: 24644193 (View on PubMed)

Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

Reference Type BACKGROUND
PMID: 19565683 (View on PubMed)

Hamano J, Oishi A, Kizawa Y. Identified Palliative Care Approach Needs with SPICT in Family Practice: A Preliminary Observational Study. J Palliat Med. 2018 Jul;21(7):992-998. doi: 10.1089/jpm.2017.0491. Epub 2018 Feb 9.

Reference Type BACKGROUND
PMID: 29425053 (View on PubMed)

Pimentel, J. P., Durval, M., Araújo, F. O. & Guerreiro, A. C. ACeS Baixo Mondego. (2017).

Reference Type 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].

Reference Type BACKGROUND

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE-UBI-Pj-2019-023:ID1244

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhancing Palliative Care in ICU
NCT06605079 RECRUITING NA
Palliative Care Educator
NCT04857060 COMPLETED NA
Advanced Dementia and End-of-life
NCT03548142 COMPLETED NA