Palliative CareGerPal-IDNCT04010136
Identification of Elderly Patients in Need of Palliative Care by Family Physicians
A study testing Palliative care training in people with Palliative Care and Primary Health Care, run by University of Beira Interior at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Primary Health Care, Geriatrics
- What is being tested?
- Palliative care training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- GPs (fellows and specialists) from Center Healthcare Administrative Region
Who cannot join
- Previous palliative care training.
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The study consists of two phases:
- 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.
- 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
- Palliative Care, Primary Health Care, Geriatrics
- Being tested
- Palliative care training
- Keywords
- Palliative care, Primary health care, Palliative care training, Prevalence, Geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative care trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Palliative care training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Nov 2019
- Primary completion29 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: We were not able to recruit participants to enrol the study. As it was not able, the investigation team decided not to proced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Seiça Cardoso, University of Beira Interior
- Investigators
- Carlos Seiça Cardoso, MD, Principal investigator, Faculty of Health Science - University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010136
- Sponsor's protocol ID
- CE-UBI-Pj-2019-023:ID1244
- Acronym
- GerPal-ID
- Status last verified
- Oct 2022
- First submitted
- 14 Jun 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25468153Murray 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.
PubMed 25395577Mitchell GK. How well do general practitioners deliver palliative care? A systematic review. Palliat Med. 2002 Nov;16(6):457-64. doi: 10.1191/0269216302pm573oa.
PubMed 12465692McWhinney 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.
PubMed 7510562Morrison 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.
PubMed 21383364Hall 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.
PubMed 21412898De 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.
PubMed 24694377Beernaert 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.
PubMed 25852203K, T. Using prognostic indicator guidance to plan care for final stages of life. Prim. Heal. Care 6, 25-28 (2010).
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.
PubMed 21801517Maas 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.
PubMed 24950525Walsh 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.
PubMed 26201214Hamano 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.
PubMed 30447382Gomez-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.
PubMed 24403380Highet 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.
PubMed 24644193
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04010136
- Acronym / sponsor ID
- GerPal-ID / CE-UBI-Pj-2019-023:ID1244
- Conditions
- Palliative Care, Primary Health Care, Geriatrics
- Keywords
- Palliative care, Primary health care, Palliative care training, Prevalence, Geriatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were not able to recruit participants to enrol the study. As it was not able, the investigation team decided not to proced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 29 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study consists of two phases:
- 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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –GPs (fellows and specialists) from Center Healthcare Administrative Region that will be given no intervention |
| Identification tool group | Experimental | Other: Palliative care trainingGPs (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. |
| Standard Palliative Care Training | Experimental | Other: Palliative care trainingGPs (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. |
| Clinical cases based Palliative Care Training | Experimental | Other: Palliative care trainingGPs (fellows and specialists) from Center Healthcare Administrative Region that will receive palliative care training using a clinical cases based model. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GPs (fellows and specialists) from Center Healthcare Administrative Region
Key exclusion criteria (2 listed)
- Previous palliative care training.
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative care trainingIntervention will consist on providing different types of palliative care training to identify the most accurate on improving GPs' identification of palliative care patients skills | Other | Clinical cases based Palliative Care Training, Identification tool group, Standard Palliative Care Training |
Primary outcome
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.
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.
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.
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 25468153Prince 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.
- Background: PubMed 25395577Murray 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.
- Background: PubMed 12465692Mitchell GK. How well do general practitioners deliver palliative care? A systematic review. Palliat Med. 2002 Nov;16(6):457-64. doi: 10.1191/0269216302pm573oa.
- Background: PubMed 7510562McWhinney 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.
- Background: PubMed 21383364Morrison 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.
- Background: PubMed 21412898Hall 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.
- Background: PubMed 24694377De 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.
- Background: PubMed 25852203Beernaert 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.
- BackgroundK, T. Using prognostic indicator guidance to plan care for final stages of life. Prim. Heal. Care 6, 25-28 (2010).
- Background: PubMed 21801517Abarshi 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.
- Background: PubMed 24950525Maas 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.
- Background: PubMed 26201214Walsh 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Seiça Cardoso, MD principal investigator
Faculty of Health Science - University of Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative care training in people with Palliative Care and Primary Health Care, run by University of Beira Interior at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GPs' rate of identification of patients with palliative care needs (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010136, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.