Age ProblemNCT06431659
Swedish Palliative Care Guide (S-PCG) at Nursing Homes
An observational study of Age Problem and Old Age; Debility, run by Region Skane at 1 site in Sweden.
Trial summary
Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. Read more about this study
- Who is it for?
- Ages 65 to 130 years
- Conditions the study is for
- Age Problem, Old Age; Debility, Dementia
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 27 May 2024to 3 May 2030
- 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 to 130 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients living at nursing homes. Relatives to the included patients. Personal working at nursing homes
Who may be able to join
- Living at one of the nursing homes that participates in the study and consents to the study or that next of kin consents (in case of excessively impaired cognition).
Who cannot join
- That the person is dying or too ill to be asked about participation.
- That the person is not capable of giving their informed consent (e.g. due to their dementia) and missing relatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. The Institute for Palliative Care, Lund, has developed the Swedish Palliative Care Guide (S-PCG) which support for a person-centred approach throughout the palliative care process.
The aim of this study is to improve palliative care for people living at nursing homes, including people with dementia and cognitive impairment, this will be achieved by providing support for health care staff working with this group of patients, investigating evidence for a palliative care the support tool, the Swedish Palliative Care Guide (S-PCG) part 2, and integrating the palliative care approach earlier in the disease trajectory, to improve the quality of care for this patient group. The research questions will be explored from the perspective of the patient, the family, and the staff.
Read the detailed description
The study will include six-ten (based on number of patients in every cluster) nursing homes who are interested in implementing the S-PCG part 2. Among the included nursing homes half will be randomized to get help to implement the S-PCG immediately (active group), while the other half will get the same help somewhat later, and act as a control group until then (control group). The process of implementing S-PCG includes education and training in using the Care guide, this training is available physically as well as digitally. The implementation process, including education and training for staff, normally takes three months. To investigate the effect of the Care Guide among patients and families, a survey will be used among the patients' and their families at start of the study in the control group and after the end of the implementation period in the active group. The patients and family members who are willing to participate in the research will be asked to answer a one-page questionnaire about their experience of the care and about the future care. In patients that are not capable of an informed consent, we will only approach the families. All questions will be answered on a five-point Likert scale. The first part of the questionnaire (seven questions) are from the validated Swedish National Patient Survey and the other six questions are self-developed by the research group to explore the persons experience of planning of the care regarding to what extent they feel involved in the care, that the patient´s and relative´s wishes about future care are known to the health care professionals and that they can talk about end-of-life issues. Data from medical records will be collected regarding diagnoses, treatments, planning of treatment, communication, and restrictions of care (behandlingsbegränsningar).
Health care professionals (HCPs) will be asked to fill in a validated questionnaires about compassion fatigue among, the Compassion Fatigue Inventory (CFI) as HCPs are of high risk of fatigue. In the control group this will be performed at study start and in the control group after implementation of S-PCG. Moreover, HCPs in the active group are asked to participate in focus groups interviews regarding the implementation of the S-PCG and how it works in the clinical work.
Data collection: The cognitive function of patients will be evaluated by the HCPs together with the research staff and only those capable of writing an informed consent and answering the questionnaires will be included. Permission to ask a relative is done at inclusion. In those not able to consent, only relatives will be approached. Data will be collected from the questionnaire from patient and relatives. Questionnaires to patients will be performed on paper, together with a research person. The questionnaire will be read twice. Questionnaires to relatives will be given/sent by mail on paper, electronically or filled in by phone. Informed consent will be asked for at the same time, on paper, electronically or by phone (on tape). The questionnaires will be administered by the staff at the nursing homes and/or by staff at the Institute for Palliative Care, who will also digitalize the data. Data from questionnaires to HCPs will be given on paper or electronically as for relatives. Focus group interviews will be performed according to an interview guide at the nursing homes with 4-7 HCP participants, recorded and transcribed verbatim.
Analysis: The experiences of patients and relatives in nursing homes using the Care Guide (active group) will be compared with the experiences of families of patients in the control facilities included in the study, where the Care Guide is not yet implemented. The purpose of randomizing which nursing homes who implements the Care Guide first is to ensure that the difference that families may experience comes from the Care Guide itself, and not from the staff at a nursing home who choose to get involved and use a guide for good palliative care is better from the beginning, however adjustments of characteristics of the patients and setting might still be needed. The outcomes measured in this study is to which degree the patients and their families feel informed about the situation of the patient and their sense of security with the future care, after the Care Guide has been used.
- Conditions
- Age Problem, Old Age; Debility, Dementia
- Keywords
- Palliative care, Elderly, Nursing homes, Dementia
- Medical subject headings
- Frailty, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active group | The S-PCG is a person-centered decision support to identify, assess, document and meet palliative care needs and increase patients' quality of life and participation in their health-care decisions. The purpose of the S-PCG is to ensure the quality of care in continuous dialogue between health care staff, patient, and family, from the transition from curative to palliative care, to the patient dying, and the care afterwards. In the Care Guide, the patients' plans and wishes are documented, and based on this care be prioritized, planned, and coordinated. The S-PCG is adapted to be used throughout the health and medical care and in municipal care. The S-PCG consists of three parts that can be used separately, the intervention in this study includes S-PCG part 2 and 2D. In the active group the nursing homes will get our help to implement the S-PCG immediately, and data will be collected after the implementation. | |
| Control group | The S-PCG is a person-centered decision support to identify, assess, document and meet palliative care needs and increase patients' quality of life and participation in their health-care decisions. The purpose of the S-PCG is to ensure the quality of care in continuous dialogue between health care staff, patient, and family, from the transition from curative to palliative care, to the patient dying, and the care afterwards. In the Care Guide, the patients' plans and wishes are documented, and based on this care be prioritized, planned, and coordinated. The S-PCG is adapted to be used throughout the health and medical care and in municipal care. The S-PCG consists of three parts that can be used separately, the intervention in this study includes S-PCG part 2 and 2D. In the control group data will be collected before the implementation of S-PCG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To which degree the patients and their families feel informed about the situation of the patient.
Measured by likert scale, 1-5. Higher number indicate higher experience of information.
Measured: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
To what degree the patients and their families feel secure about the future care that the patient will receive.
Measured by likert scale, 1-5. Higher number indicate higher experience of security.
Measured: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Secondary outcomes (2)
Breakpoint conversation
Presence of documented break point conversations in medical records.
Measured: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Treatment limitations
Presence of documented treatment limitations in medical records.
Measured: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start27 May 2024
- Primary completion3 May 2029 (estimated)
- Study completion3 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Schelin, ass. prof., Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431659
- Sponsor's protocol ID
- 2024-00597-01, 2023-02274-01
- Status last verified
- May 2026
- First submitted
- 16 May 2024
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Palliative Care Guide (S-PCG) at Nursing Homes
- ClinicalTrials.gov ID
- NCT06431659
- Acronym / sponsor ID
- 2024-00597-01, 2023-02274-01
- Conditions
- Age Problem, Old Age; Debility, Dementia
- Keywords
- Palliative care, Elderly, Nursing homes, Dementia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 3 May 2029 (estimated)
- Study completion
- 3 May 2030 (estimated)
- First posted
- 28 May 2024 (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.
Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. The Institute for Palliative Care, Lund, has developed the Swedish Palliative Care Guide (S-PCG) which support for a person-centred approach throughout the palliative care process.
The aim of this study is to improve palliative care for people living at nursing homes, including people with dementia and cognitive impairment, this will be achieved by providing support for health care staff working with this group of patients, investigating evidence for a palliative care the support tool, the Swedish Palliative Care Guide (S-PCG) part 2, and integrating the palliative care approach earlier in the disease trajectory, to improve the quality of care for this patient group. The research questions will be explored from the perspective of the patient, the family, and the staff.
Detailed description
The study will include six-ten (based on number of patients in every cluster) nursing homes who are interested in implementing the S-PCG part 2. Among the included nursing homes half will be randomized to get help to implement the S-PCG immediately (active group), while the other half will get the same help somewhat later, and act as a control group until then (control group). The process of implementing S-PCG includes education and training in using the Care guide, this training is available physically as well as digitally. The implementation process, including education and training for staff, normally takes three months. To investigate the effect of the Care Guide among patients and families, a survey will be used among the patients' and their families at start of the study in the control group and after the end of the implementation period in the active group. The patients and family members who are willing to participate in the research will be asked to answer a one-page questionnaire about their experience of the care and about the future care. In patients that are not capable of an informed consent, we will only approach the families. All questions will be answered on a five-point Likert scale. The first part of the questionnaire (seven questions) are from the validated Swedish National Patient Survey and the other six questions are self-developed by the research group to explore the persons experience of planning of the care regarding to what extent they feel involved in the care, that the patient´s and relative´s wishes about future care are known to the health care professionals and that they can talk about end-of-life issues. Data from medical records will be collected regarding diagnoses, treatments, planning of treatment, communication, and restrictions of care (behandlingsbegränsningar).
Health care professionals (HCPs) will be asked to fill in a validated questionnaires about compassion fatigue among, the Compassion Fatigue Inventory (CFI) as HCPs are of high risk of fatigue. In the control group this will be performed at study start and in the control group after implementation of S-PCG. Moreover, HCPs in the active group are asked to participate in focus groups interviews regarding the implementation of the S-PCG and how it works in the clinical work.
Data collection: The cognitive function of patients will be evaluated by the HCPs together with the research staff and only those capable of writing an informed consent and answering the questionnaires will be included. Permission to ask a relative is done at inclusion. In those not able to consent, only relatives will be approached. Data will be collected from the questionnaire from patient and relatives. Questionnaires to patients will be performed on paper, together with a research person. The questionnaire will be read twice. Questionnaires to relatives will be given/sent by mail on paper, electronically or filled in by phone. Informed consent will be asked for at the same time, on paper, electronically or by phone (on tape). The questionnaires will be administered by the staff at the nursing homes and/or by staff at the Institute for Palliative Care, who will also digitalize the data. Data from questionnaires to HCPs will be given on paper or electronically as for relatives. Focus group interviews will be performed according to an interview guide at the nursing homes with 4-7 HCP participants, recorded and transcribed verbatim.
Analysis: The experiences of patients and relatives in nursing homes using the Care Guide (active group) will be compared with the experiences of families of patients in the control facilities included in the study, where the Care Guide is not yet implemented. The purpose of randomizing which nursing homes who implements the Care Guide first is to ensure that the difference that families may experience comes from the Care Guide itself, and not from the staff at a nursing home who choose to get involved and use a guide for good palliative care is better from the beginning, however adjustments of characteristics of the patients and setting might still be needed. The outcomes measured in this study is to which degree the patients and their families feel informed about the situation of the patient and their sense of security with the future care, after the Care Guide has been used.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | – | –The S-PCG is a person-centered decision support to identify, assess, document and meet palliative care needs and increase patients' quality of life and participation in their health-care decisions. The purpose of the S-PCG is to ensure the quality of care in continuous dialogue between health care staff, patient, and family, from the transition from curative to palliative care, to the patient dying, and the care afterwards. In the Care Guide, the patients' plans and wishes are documented, and based on this care be prioritized, planned, and coordinated. The S-PCG is adapted to be used throughout the health and medical care and in municipal care. The S-PCG consists of three parts that can be used separately, the intervention in this study includes S-PCG part 2 and 2D. In the active group the nursing homes will get our help to implement the S-PCG immediately, and data will be collected after the implementation. |
| Control group | – | –The S-PCG is a person-centered decision support to identify, assess, document and meet palliative care needs and increase patients' quality of life and participation in their health-care decisions. The purpose of the S-PCG is to ensure the quality of care in continuous dialogue between health care staff, patient, and family, from the transition from curative to palliative care, to the patient dying, and the care afterwards. In the Care Guide, the patients' plans and wishes are documented, and based on this care be prioritized, planned, and coordinated. The S-PCG is adapted to be used throughout the health and medical care and in municipal care. The S-PCG consists of three parts that can be used separately, the intervention in this study includes S-PCG part 2 and 2D. In the control group data will be collected before the implementation of S-PCG. |
Who may qualify
- Ages
- 65 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients living at nursing homes. Relatives to the included patients. Personal working at nursing homes
Key inclusion criteria (1 listed)
- Living at one of the nursing homes that participates in the study and consents to the study or that next of kin consents (in case of excessively impaired cognition).
Key exclusion criteria (2 listed)
- That the person is dying or too ill to be asked about participation.
- That the person is not capable of giving their informed consent (e.g. due to their dementia) and missing relatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To which degree the patients and their families feel informed about the situation of the patient.
Time frame: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Measured by likert scale, 1-5. Higher number indicate higher experience of information.
To what degree the patients and their families feel secure about the future care that the patient will receive.
Time frame: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Measured by likert scale, 1-5. Higher number indicate higher experience of security.
2 secondary outcomes
Breakpoint conversation
Time frame: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
Treatment limitations
Time frame: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.
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 13 May 2026.
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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.
Maria Schelin, ass. prof. principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Problem and Old Age; Debility, run by Region Skane at 1 site in Sweden.
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: enrolling by invitation, as of the sponsor's last update on 13 May 2026. 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 Sweden. 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?
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?
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?
To which degree the patients and their families feel informed about the situation of the patient. (time frame: Data will be collected through study completion, an average of 2 years, data will be collected only on time per patient.). The study lists 2 primary outcomes in all. 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 13 May 2026.