GeriatricPALMA cohortNCT06911411
PALLIATIVE ASSESSMENT COHORT IN THE GERIATRIC EMERGENCY SETTING
An observational study of Geriatric and Palliative Care, run by University Hospital Bispebjerg and Frederiksberg.
Trial summary
The PALMA project is part of a larger palliative research program COPAL in Capital Region of Denmark led by Professor Tom Møller. PALMA aims to improve palliative care for geriatric patients transitioning from emergency-hospital to primary care. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric, Palliative Care, Socio-demographic Risk
- What is being tested?
- Prospective observational cohort study. and A prospective observational cohort study
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients in the geriatric emergency department are 65 years of age or older and referred by their own general practitioner or specialist for assessment and treatment of an acute medical problem. Approximately one-third are admitted and two-thirds are discharged to home facilities.
Inclusion Criteria: Older patient >64 years acutely admitted to the geriatric emergency department -
Exclusion Criteria: Severe cognitive impairment. Not able to provide informed consent. Not reading Danish
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trine Hasloev H Project leader, Master of Science contact
About this study
Official title: PALLIATIVE ASSESSMENT AND MANAGEMENT IN THE GERIATRIC EMERGENCY SETTING (PALMA)
The PALMA project is part of a larger palliative research program COPAL in Capital Region of Denmark led by Professor Tom Møller. PALMA aims to improve palliative care for geriatric patients transitioning from emergency-hospital to primary care. The project addresses the lack of a systematic approach for assessing and managing palliative symptoms in geriatric patients to enhance communication between hospitals and municipal health care services.
The PALMA cohort investigates the applicability of systematic palliative assessment (EORTC-C15 PAL) in the geriatric emergency setting combined with measures of frailty, socio-demographic risks, and cross-sectoral healthcare support.
Read the detailed description
In Denmark, there is a lack of systematic workflows for basic palliative care and relief. There is evidence that conversations about palliative needs during hospitalization should be initiated by healthcare professionals, as patients and relatives do not necessarily bring up the need themselves due to doubts about the relevance of the hospital contact, but also ambiguity and ambivalence regarding wishes and options for medical treatment in the last part of life are experienced as barriers.
PALMA is an implementation research project and classified as T3 on the translational scale. Inspired by The Medical Research Council (MRC), the intervention is developed through the involvement of relevant stakeholders, including patients and relatives, to ensure relevance. In addition, the feasibility is tested in a comprehensive feasibility study with a view to adapting to already established workflows.
The PALMA cohort is aimed at the part of the intervention development that will develop a stratification tool for identifying older people at risk of dying within 180 days, as well as the algorithm that will define the weight of the cross-sectoral communication regarding identified palliative needs and hospital-outgoing activities for relief.
Establishing a cohort enables to measure the EORTC-C15 PAL and Clinical Frailty Scale (CFS) applicability to the geriatric population of interest. Data are intended to inform risk stratification in a following implementation feasibility study. In PALMA we intend to identify elderly with high risk of dying within three months.
By potentially adding a time-consuming process of palliative assessment and management to a considerable workload at the geriatric emergency department is likely to act as a barrier for implementation. Hence, a non-time-consuming risk stratification process must be identified, which forms the objective of the PALMA cohort study.
In previous studies we have shown frailty, measures by CFS to be a moderate predictor of 90-day mortality and may along with immobilization status serve as quick and reliable identifier of patients at risk of dying within 90 or 180 days. The EORTC-C15 PAL is a key validated European instrument to measure patients' palliative needs. It has mostly been tested in patients in Specialised Palliative Care units and thus, we do not know if the instrument is meaningful to uncover palliative care needs in geriatric patients.
Likewise, we do not know whether the EORTC-C15 PAL corresponds with the degree of frailty or severe immobility at an acute hospital admission at the emergency department. But across various common diseases, we do know that underlying sociodemographic inequality factors and premises may mediate increased mortality and health care utilization considerably.
Cohort methodology: To answer the research question of whether frailty and/or immobility may significantly identify patients with palliative care needs the association (regression coefficient and/or relative risk) and the area under receiver operating characteristic (AUROC) curve between the assumed risk assessment tools and high score of EORTC-C15 PAL is investigated in a cross-sectional cohort design. Further, the cohort is followed for 90-day mortality to test the association between EORTC-C15 PAL scores and mortality in acutely admitted geriatric patients. (See table I for more specific question asked).
Question asked:
- What is the association between EORTC-C15 PAL scores, CFS and immobility, and how are these associations mediated by sociodemographic characteristics?
- May CFS/immobility assessment be used as quick screening tool for high symptom risk stratification?
With a total sample size of 198 patients (99 frail and 99 non-frail), the study will have a power of 80% at an alpha of 0.05% to detect a minimum clinically relevant difference of 10 points on PRO-PAL symptom scales. To meet 10% dropout, 10% of PRO-PAL possibly being filled out inappropriately due to severe cognitive impairment and securing 99 frail patients in a consecutive inclusion design, the total sample size of the cohort is set at 300 patients.
- Conditions
- Geriatric, Palliative Care, Socio-demographic Risk, Frailty at Older Adults, Loneliness, Collaborative Care
- Being tested
- Prospective observational cohort study., A prospective observational cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective observational cohort study.Other
No systematic approach exists for symptom assessment, management, and reporting in delivered basic palliative care within the Danish healthcare system, implying considerable variation in hospital-based palliative care. The PALMA study consists of two superior phases divided in a development and an implementation stage that anchors basic palliative assessment and management within existing geriatric workflows and cross-sectoral collaborative care.
The PALMA cohort will test the applicability of the EORTC-C15-PAL questionnaire along with measures of clinical frailty and sociodemographic risk factors.
The development phase will enable the development of a clinical algorithm for elderly patients' need for cross-sectoral palliation care planning.
A prospective observational cohort studyOther
Observational design
| Study group | Role | What they receive |
|---|---|---|
| Palliative assessment group of acutely admitted older patients | Not described Receives: Other: Prospective observational cohort study.; Other: A prospective observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rates at 3 and 6 months
Measured: Patient observation time is 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Health Authority
- Responsible party
- Principal investigator, Trine Herskind Hasløv, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911411
- Sponsor's protocol ID
- Capital Region DK P-2023-15
- Acronym
- PALMA cohort
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are unaware, whether data that originates from patient journals in an anomynous form may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALLIATIVE ASSESSMENT AND MANAGEMENT IN THE GERIATRIC EMERGENCY SETTING (PALMA)
- ClinicalTrials.gov ID
- NCT06911411
- Acronym / sponsor ID
- PALMA cohort / Capital Region DK P-2023-15
- Conditions
- Geriatric, Palliative Care, Socio-demographic Risk, Frailty at Older Adults, Loneliness, Collaborative Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- The Danish Health Authority
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Apr 2025 (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.
The PALMA project is part of a larger palliative research program COPAL in Capital Region of Denmark led by Professor Tom Møller. PALMA aims to improve palliative care for geriatric patients transitioning from emergency-hospital to primary care. The project addresses the lack of a systematic approach for assessing and managing palliative symptoms in geriatric patients to enhance communication between hospitals and municipal health care services.
The PALMA cohort investigates the applicability of systematic palliative assessment (EORTC-C15 PAL) in the geriatric emergency setting combined with measures of frailty, socio-demographic risks, and cross-sectoral healthcare support.
Detailed description
In Denmark, there is a lack of systematic workflows for basic palliative care and relief. There is evidence that conversations about palliative needs during hospitalization should be initiated by healthcare professionals, as patients and relatives do not necessarily bring up the need themselves due to doubts about the relevance of the hospital contact, but also ambiguity and ambivalence regarding wishes and options for medical treatment in the last part of life are experienced as barriers.
PALMA is an implementation research project and classified as T3 on the translational scale. Inspired by The Medical Research Council (MRC), the intervention is developed through the involvement of relevant stakeholders, including patients and relatives, to ensure relevance. In addition, the feasibility is tested in a comprehensive feasibility study with a view to adapting to already established workflows.
The PALMA cohort is aimed at the part of the intervention development that will develop a stratification tool for identifying older people at risk of dying within 180 days, as well as the algorithm that will define the weight of the cross-sectoral communication regarding identified palliative needs and hospital-outgoing activities for relief.
Establishing a cohort enables to measure the EORTC-C15 PAL and Clinical Frailty Scale (CFS) applicability to the geriatric population of interest. Data are intended to inform risk stratification in a following implementation feasibility study. In PALMA we intend to identify elderly with high risk of dying within three months.
By potentially adding a time-consuming process of palliative assessment and management to a considerable workload at the geriatric emergency department is likely to act as a barrier for implementation. Hence, a non-time-consuming risk stratification process must be identified, which forms the objective of the PALMA cohort study.
In previous studies we have shown frailty, measures by CFS to be a moderate predictor of 90-day mortality and may along with immobilization status serve as quick and reliable identifier of patients at risk of dying within 90 or 180 days. The EORTC-C15 PAL is a key validated European instrument to measure patients' palliative needs. It has mostly been tested in patients in Specialised Palliative Care units and thus, we do not know if the instrument is meaningful to uncover palliative care needs in geriatric patients.
Likewise, we do not know whether the EORTC-C15 PAL corresponds with the degree of frailty or severe immobility at an acute hospital admission at the emergency department. But across various common diseases, we do know that underlying sociodemographic inequality factors and premises may mediate increased mortality and health care utilization considerably.
Cohort methodology: To answer the research question of whether frailty and/or immobility may significantly identify patients with palliative care needs the association (regression coefficient and/or relative risk) and the area under receiver operating characteristic (AUROC) curve between the assumed risk assessment tools and high score of EORTC-C15 PAL is investigated in a cross-sectional cohort design. Further, the cohort is followed for 90-day mortality to test the association between EORTC-C15 PAL scores and mortality in acutely admitted geriatric patients. (See table I for more specific question asked).
Question asked:
- What is the association between EORTC-C15 PAL scores, CFS and immobility, and how are these associations mediated by sociodemographic characteristics?
- May CFS/immobility assessment be used as quick screening tool for high symptom risk stratification?
With a total sample size of 198 patients (99 frail and 99 non-frail), the study will have a power of 80% at an alpha of 0.05% to detect a minimum clinically relevant difference of 10 points on PRO-PAL symptom scales. To meet 10% dropout, 10% of PRO-PAL possibly being filled out inappropriately due to severe cognitive impairment and securing 99 frail patients in a consecutive inclusion design, the total sample size of the cohort is set at 300 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative assessment group of acutely admitted older patients | – | Other: Prospective observational cohort study., Other: A prospective observational cohort study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients in the geriatric emergency department are 65 years of age or older and referred by their own general practitioner or specialist for assessment and treatment of an acute medical problem. Approximately one-third are admitted and two-thirds are discharged to home facilities.
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 |
|---|---|---|
| Prospective observational cohort study.No systematic approach exists for symptom assessment, management, and reporting in delivered basic palliative care within the Danish healthcare system, implying considerable variation in hospital-based palliative care. The PALMA study consists of two superior phases divided in a development and an implementation stage that anchors basic palliative assessment and management within existing geriatric workflows and cross-sectoral collaborative care. The PALMA cohort will test the applicability of the EORTC-C15-PAL questionnaire along with measures of clinical frailty and sociodemographic risk factors. The development phase will enable the development of a clinical algorithm for elderly patients' need for cross-sectoral palliation care planning. | Other | Palliative assessment group of acutely admitted older patients |
| A prospective observational cohort studyObservational design | Other | Palliative assessment group of acutely admitted older patients |
Primary outcome
Mortality
Time frame: Patient observation time is 6 months
Mortality rates at 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. We are unaware, whether data that originates from patient journals in an anomynous form may be shared.
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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.
Trine Hasloev H Project leader, Master of Science contact
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric and Palliative Care, run by University Hospital Bispebjerg and Frederiksberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trine Hasloev H Project leader, Master of Science (+4522475483, trine.herskind.hasloev@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Patient observation time is 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.