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
Phase: NA
Conditions: Palliative Care, Primary Health Care, Geriatrics
Sponsor: University of Beira Interior

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. 
 
 
Date 
 
10th June 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
Authors 
Carlos Seiça Cardoso (CSC), carlos.asc4@gmail.com 
Filipe Prazeres (FP), filipeprazeresmd@gmail.com 
Bárbara Gomes (BG), barbara.gomes@kcl.ac.uk 
 
Corresponding author 
Carlos Alexandre de Seiça Cardoso 
Rua Fonte da Incha nº 10, 3025-556, Coimbra, Portugal 
916902294 
 
 
 
Keywords 
Palliative Care, Primary Health Care, Geriatrics, Palliative Care Training, Identification tool.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
Abstract 
 
Introduction 
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. 
 
Methods and analysis 
This study protocol describes a primary care two-phase study. The first phase is designed to access 
the role of palliative care training and the use of a structured tool in the accuracy of recognizing 
patients with palliative care needs by family physicians. A four-harm trial will be conducted to access 
which intervention provides a more accurate identification of patients with palliative care needs by 
family physicians. 
In the second phase, once the most accurate identification strategy has been found, a prevalence 
study will be conducted in Center Healthcare Administrative Region, in order to identify geriatric 
patients, managed in primary care, who have palliative care needs and try to identify their care need 
complexity. 
 
Ethics and dissemination 
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.  
 
Article Summary 
¨ The palliative care training program will be structured according GPs’ perception about 
palliative care training needs. 
¨ Development of a tool the assess accuracy in the identification of geriatric patients with 
palliative care needs. 
¨ GPs will be randomized and compared in a four-arm vs control trial to identify the best 
intervention to assess palliative care needs.  
¨ The prevalence study will evaluate a representative sample of Health Region of Portugal’s 
geriatric patients. 
¨ GPs’ sample will be a convenience one, evaluating those who already are interested in 
palliative care. 
 
 
 

 
 
 
Introduction 
In the last decades, the number of people living with chronic diseases had increased, mainly due to 
the aging of the population, leading to an increase in dependency status and entailing important 
social costs. 1 
 
These chronic, progressive, life threatening and burden diseases, play an important role in this new 
era of Palliative Care (PC) approach.  
 
Most patients with chronic illness are managed in primary care over a long period of time.2General 
Practitioners (GP), can play an important role in the PC network. When the GP is involved, the 
provision of PC seems to improve, with benefits for both patients and their families. 3,4 
 
Some evidence also show that there is a benefit in an early integration of palliative care, following 
global patient care in several diseases 5,6, although GPs report not having the knowledge and skills to 
assess unmet needs. 7,8 
 
Side by side with PC training, it is increasingly known that systematic identification tools can improve the 
recognition of patients with PC needs, becoming an important strategy to provide an earlier palliative 
approach to these patients. 9,10 
 
According to a recent review, there are several tools appropriate for primary care use 11, and the 
SPICTTM shows to be one of  most suitable for this context. 12  
 
The prevalence of elderly patients with palliative care needs can go from 8,0-17,3%, 13,14 according 
to differences in the  population studied and tool used.  
It seems to be consonant that knowing the prevalence  and characteristics of patients that may be in 
risk of deteriorating in primary healthcare can help GPs identify such patients earlier, help them to 
overcome the barriers to initiate end-of-life discussions conducting to a more efficient strategy to 
achieve each patient’s care goals. 7,13 
Study Objectives 
The primary objective of the study described in the protocol is to perform a randomized trial to 
ascertain if PC training and the use of a structured tool (Portuguese version of SPICTTM) 15 can 
improve GP’s correct identification of geriatric patients with palliative care needs. 
 
Specific objectives are to:  
¨ Perform a Clinical cases base PC training program for GPs, addressing the importance of an 
efficient identification of geriatric patients managed in primary care. 
¨ Develop a Clinical Cases Based Tool for Palliative Care Identification (CCB-PCId), to evaluate 
the accurate identification of patients with palliative care needs 
¨ Assess whether different training programs and a structured tool can improve GPs 
awareness to a correct identification of geriatric patients with palliative care needs. 
¨ Investigate the real prevalence and characteristics of primary care geriatric outpatients, 
managed in Center Healthcare Administrative Region, with PC needs. 
 
 
Methods and analysis 
 
Study design 

 
The study consists of two phases:  
¨ Randomized trial with GPs to determine the role of two different training programs and a 
structured tool in the identification of geriatric patients with palliative care needs. 
¨ Cross-sectional, analytical study of the prevalence and patterns of geriatric patients with PC 
needs, managed in primary care in Portugal’s Center Healthcare Administrative Region. 
 
Phase I: the role of a palliative care training program and of a structured tool in the 
identification of patients with palliative care needs. 
 
Design 
Randomized clinical trial 
 
Setting  
GPs (fellows and specialists) from Center Healthcare Administrative Region will be invited to take 
part in the study. Those who accept, will be randomized into four harms (Control group, receiving 
only a structured tool, receiving standard PC training, receiving clinical cases based PC training). 
Then, each group will be given the CRB-PCId before and after intervention and the scores will be 
compared within the group and between groups. 
 
 
Pre-study procedures  
A PC expert panel will take part in two pre-study steps: (i) The PC training program and (ii) the CCB-
PCId construction. 
 
The PC training program for primary care 
According to the results of two online focus groups with GPs and the PC expert panel, a PC training 
program for GPs will be built, focusing on the role of GPs in the PC network, the importance and the 
knowhow about patients with palliative care needs’ identification. 
 
CCB-PCId 
The PC expert panel will build a tool, clinical record based, to evaluate the accuracy of palliative 
care needs identification. 
This tool will consist of a set of clinical cases from fictitious patients, some of those in need of 
palliative care and others without, according to the PC expert panel.  
The accuracy’s pre and after intervention, will be measured and compared to evaluate differences 
within group and between groups of the randomized trial. 
 
Sample size  
From the bibliographic research, it was not possible to infer the expected behavior in each group. 
Thus, the sample was calculated according to the Cohen Tables 16, for a four-harm comparison, with 
analysis of dichotomous variables, with a test power of 80% and a significance of 0.05. A total of 45 
GPs was obtained per group, making up a minimum sample of 180.  
 
 Study procedures 
This phase of the study is expected to start in September 2019. 
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 
(defined as a standard PC training model used in Center Healthcare Administrative Region) , 4 – 
Clinical cases based PC training. 

 
Standardization will be performed so that GPs randomization take into account the different inner 
sample characteristics. 
 
 
 
 
Then, each group will be asked to perform CCB-PCId before and after completing the group 
intervention: 
 
¨ Control Group – no intervention; 
¨ Identification tool group – before and after getting the SPICTPT and a short explanation on 
how to use it; 
¨ Standard PC training group – before and after training program;  
¨ Clinical cases based PC training group – before and after training program; 
 
The accuracy on the identification before and after intervention will be compared within each group 
and between the four groups, to determine which study harm is the most accurate one.  
 
 
Data collection  
The main investigator will be responsible to store the data collected during the trial. 
Besides the main outcome of this phase is to determine which intervention provides the most 
accurate identification, to control some confusing variables, it will be collected some demographic 
data, such as age, sex, place of work, work experience (years) and previous training in PC. 
Data will be electronically stored in a database specifically designed for this study. Data will be 
encrypted and password protected. Information will be treated in strict confidentiality to protect the 
privacy of GPs.  Paper copies of all informed consents will be retained in a locked file, separate from 
any study data.  
Statistical analysis  
A descriptive analysis will be performed to all study variables, namely the number of valid 
observations, mean, SD, median and range for quantitative variables and absolute and relative 
frequencies for qualitative variables whenever it will be considered adequate. 
According to previous reports 13,17, patients with palliative care needs will be defined as ≥2 positive 
general indicators or ≥1 positive disease-specific indicators in the SPICTPT.  
Comparisons between two or more independent groups of quantitative variables will be performed 
using Pearson’s c2 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 SPSS V.24.0 or higher.  
Phase II: prevalence of palliative care needs and care need complexity among geriatric 
patients managed in primary care in the Center Healthcare Administrative Region – Portugal 
Design 
Cross-sectional, analytical study.  
Setting  
GPs from Centre Healthcare Administrative Region, that accepted to participate in phase I, will be 
asked to screen geriatric patients in their files to determine the prevalence of geriatric patients with 
PC needs and their care need complexity in Centre Healthcare Administrative Region. 

Sample size  
According to Center Healthcare Administrative Region’s Local health profile 201718, there are 
402471 individuals aged 65 or more. This value was assumed as these individuals were all 
managed in primary care to maximize the sample size. 
Since the prevalence of geriatric patients managed in primary care with palliative care needs varies 
greatly across research literature, a prevalence of 50% was assumed in order to maximize the sample 
size. For the study to be able to estimate a 95% CI for the prevalence of geriatric patients managed 
in primary care with palliative care needs with a maximum precision error of 2.5%, a total of 1531 
patients should be screened. 
To safeguard a 30% dropout rate, each of the 180 GPs will be asked to evaluate at least 13 of their 
clinical files’ managed geriatric patients. This data may be recalculated according to the phase I 
sample dropout, always granting the minimal required sample size. 
 
Study procedures  
According to phase I results, the most accurate intervention will be available to all GPs, to maximize 
their identification’s capacity. 
Then, all GPs recruited will be asked to participate in a cross-sectional, analytical study with three 
aims: 
¨ Determine the prevalence of geriatric patients with palliative care needs managed in 
primary care in Center Healthcare Administrative Region; 
¨ Determine these patients care need complexity applying a translated version of IDC-Pal19; 
¨ Determine demographic and clinical characteristics of these patients. 
Each GP will be asked to evaluate at least 9 patients from his clinical file, according to a convenience 
sample built with patients undergoing for a medical evaluation during a determined period.  
Patients willing to participate in the study must give written informed consent and present 
willingness and ability to comply with the study requirements. Participants will be excluded if they 
are acutely unwell or refuse to participate. Every patient aged above 65 years old, accepting to 
participate, will be admitted for screening. 
Data collection  
GPs will be responsible for collecting all data about each patient during their consultations and 
through the completion of a paper questionnaire developed specifically for this study.  
The geriatric patients’ palliative care needs will be assessed using the knowledge of GPs enrolled 
(attending they have all received PC training program) and using the SPICTPT according to phase I 
defined parameters. 
The patients’ care need complexity will be screened according to ICD-Pal translated tool results. This 
screening will only be conducted to patients with positive palliative care needs screening. 
Patients’ demographic and clinical characteristics as age, sex, residence area, living situation, main 
underlying disease and current care services will also be recorded. 
Data will be electronically stored in a database specifically designed for this study. Data will be 
encrypted and password protected. Information will be treated in strict confidentiality to protect the 
privacy of patients.  Paper copies of all informed consents will be retained in a locked file, separate 
from any study data.  
 
Statistical analysis  
A descriptive analysis will be performed to all study variables, namely the number of valid 
observations, mean, SD, median and range for quantitative variables and absolute and relative 
frequencies for qualitative variables whenever it will be considered adequate. 
Prevalence of geriatric patients with PC needs will be calculated together with corresponding 95% 
CI.  
Moreover, the prevalence of geriatric patients with PC needs will be estimated by subgroups, namely 
gender, age, residence area, main underlying disease and current care services. 

Univariate analysis will be conducted to study the associations between those characteristics and PC 
needs using χ2 test (qualitative characteristics) or T test/Mann-Whitney (quantitative 
characteristics).  
All tests will be two-sided using a significance level of 0.05. Statistical analysis will be con- ducted 
using SPSS V.24.0 or higher.  
 
 
Ethics and dissemination 
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.  
 
 
 
References 
1. 
Prince, M. J. et al. The burden of disease in older people and implications for health policy 
and practice. Lancet 385, 549–562 (2015). 
2. 
Downing, J. et al. 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. 29, 101–111 (2014). 
3. 
Mitchell, G. K. How well do general practitioners deliver palliative care? A systematic 
review. Palliat. Med. 16, 457–464 (2002). 
4. 
McWhinney, I. R. & Stewart, M. A. Home care of dying patients. Family physicians’ 
experience with a palliative care support team. Can Fam Physician 40, 240–246 (1994). 
5. 
Morrison, R. S. et al. The care span: Palliative care consultation teams cut hospital costs for 
Medicaid beneficiaries. Health Aff. 30, 454–463 (2011). 
6. 
Hall, S., Davies, E., Frogatt, K., Higginson, I. & Kolliakou, A. Interventions for improving 
palliative care for older people living in nursing care homes. Cochrane Database Syst. Rev. 
(2008). doi:10.1002/14651858.CD007132.pub2.www.cochranelibrary.com 
7. 
De Korte-Verhoef, M. C. et al. General practitioners’ perspectives on the avoidability of 
hospitalizations at the end of life: A mixed-method study. Palliat. Med. 28, 949–958 (2014). 
8. 
Devroey, D. et al. 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. Med. 33, 489–497 (2015). 
9. 
K, T. Using prognostic indicator guidance to plan care for final stages of life. Prim. Heal. Care 
6, 25–28 (2010). 
10. 
Abarshi, E. A. et al. Recognising patients who will die in the near future: A nationwide study 
via the Dutch Sentinel Network of GPs. Br. J. Gen. Pract. 61, 371–378 (2011). 
11. 
Maas, E. A. T., Murray, S. A., 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 3, 444–451 (2013). 
12. 
Walsh, R. I., Mitchell, G., Francis, L. & Driel, M. L. Van. current review what Diagnostic tools 
exist for the early identification of Palliative care Patients in General Practice ? A systematic 
review. 118–123 (2010). 
13. 
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. 57, 266–272.e1 (2019). 
14. 
Constante, C. et al. Prevalence and characteristics of patients with advanced chronic 
conditions in need of palliative care in the general population: A cross-sectional study. 
Palliat. Med. 28, 302–311 (2014). 
15. 
Highet, G., Crawford, D., Murray, S. A. & Boyd, K. Development and evaluation of the 
supportive and palliative care indicators tool (SPICT): A mixed-methods study. BMJ Support. 
Palliat. Care 4, 285–290 (2014). 
16. 
Cohen, J. A Power Primer. (1992). 
17. 
Hamano, J., Oishi, A. & Kizawa, Y. Identified Palliative Care Approach Needs with SPICT in 
Family Practice: A Preliminary Observational Study. J. Palliat. Med. 21, 992–998 (2018). 
18. 
Pimentel, J. P., Durval, M., Araújo, F. O. & Guerreiro, A. C. ACeS Baixo Mondego. (2017). 
19. 
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].  
 
 
 
Authors’ contributions: CSC, FP and BG were involved in designing of the study. FP was involved 
in writing of the manuscript. All authors read and approved the final manuscript draft.  
Funding statement This research received no specific grant from any funding agency in the public, 
commercial or not-for-profit sectors  
Competing interests statement None