Palliative CareNCT00594971
A Shared Care Approach for Seriously Ill Cancer Patients Between General Practice, Discharge Department and a Specialist Palliative Care Team
A study testing Organisational intervention and Referral to a specialist palliative care team. in people with Palliative Care and Neoplasms, run by University of Aarhus.
Trial summary
Background: Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and international research shows that the majority of terminally ill cancer patients wish to die at home. In Denmark only about 25% has this wish fulfilled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Neoplasms
- What is being tested?
- Organisational intervention and Referral to a specialist palliative care team.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be included the patients have to be diagnosed as suffering from terminal cancer. The patients should also:
- Be 18 years or older
- Be able to speak and write Danish fluently
- Give written and spoken consent
- Be able to manage in their own home, with or without the help of carers and district nurses
- Be informed about the diagnosis, also that it is incurable
- Be registered as suffering from a terminal illness or fulfil the criteria for this -
Who cannot join
- Patients are excluded if they:
- Have a low level of cognitive skills, which makes it difficult for them to fill in a questionnaire
- Are residents of a nursing home at the time of inclusion
- Are receiving oncologic treatment which requires attending an out-patients clinic regularly
- Already have established contact with a specialist palliative care team at the time of inclusion -
About this study
Background:
Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and international research shows that the majority of terminally ill cancer patients wish to die at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has traditionally had the full responsibility for the palliative care of terminally ill cancer patients. In recent years changes have been made to the organisation of palliative care: some hospitals have set up specialised palliative care teams and in some areas of Denmark hospices have been established.
Read more
Recent research defines a problem when it comes to communication between the hospital and general practice when the patient is being discharged. This is often done in a way that can cause the patient to feel "left in limbo", especially if it is not completely clear to the patient and his or her relatives who has the responsibility for the palliative care.
Objective:
- To describe consequences for patients, relatives and health care professionals of three different ways of organising palliative care
- To collect data which describes patients who are candidates to a shared care approach between general practice and a specialised palliative care team
- To collect data which describes the palliative phase (place of death and palliative care, admissions to hospital, involvement of GP and district nurse etc.)
- To describe terminally ill cancer patients and their relatives expectations of the health care system
270 terminally ill cancer patients will be invited to take part in the study. Data will be collected by interview with patients and questionnaires for patients, relatives and involved health care professionals.
Read the detailed description
The intervention in the study is of organisational character. The patients will be randomised into two groups (groups B and C). A group of usual care patients will be included primary to the intervention (group A). The groups are:
- Usual discharge with regular discharge letter to the GP. The GP, together with the community nurse, is responsible for the palliative care, including referral to a specialist palliative care team, hospice, hospital, etc., if necessary
- Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care
- Discharge with extra effort put into improving the communication between the hospital and the GP. The GP will receive a phone call from the doctor who is discharging the patient, a detailed discharge letter, written information about the patient's type of cancer and acute oncological symptoms, name and phone number of the community nurse and name and phone number of a specialist in palliative medicine, who can be contacted for advice. This is a shared care model, where focus is on supporting the health care professionals.
- Conditions
- Palliative Care, Neoplasms
- Being tested
- Organisational intervention, Referral to a specialist palliative care team.
- Keywords
- Health Services Research, Family practice
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organisational interventionOther
A shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector.
Referral to a specialist palliative care team.Other
Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care.
| Study group | Role | What they receive |
|---|---|---|
| B | Other | 90 terminally ill cancer patients will be referred to a specialist palliative care team at time of discharge. Receives: Other: Referral to a specialist palliative care team. |
| C | Other | 90 terminally ill cancer patients will be discharged from hospital with extra effort put into improving the communication between the hospital and the primary sector. Receives: Other: Organisational intervention |
| A | No intervention | 90 terminally ill cancer patients will be discharged from hospital, receiving usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients wish for place of death and place of terminal care fulfilled
Measured: The patient will be asked about preference for place of death and place for terminal care at inclusion and a month later. At the time of death we will be able to establish weather the patient had his or her wishes fulfilled.
Relative amount of time spent in hospital in the terminal phase
Measured: At the patients time of death we will be able to count number of days spent in hospital using the hospitals electronic patient files.
A subjective measure of the patients symptoms and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Palliative care [EORTC-QLQ-15-PAL])
Measured: Will be measured at the time of inclusion and a month later.
Secondary outcomes (9)
Patient's satisfaction regarding the services of the GP, district nurse and local hospital
Measured: Will be measured at inclusion and one month later.
Patient's experiences regarding cooperation and information sharing in the health care system.
Measured: Will be measured at inclusion and one month later.
Relative's satisfaction regarding the services of the GP, district nurse and local hospital.
Measured: Will be measured at inclusion, one month later and 2 months after the patients death.
Relative's experiences regarding cooperation and information sharing in the health care system.
Measured: Will be measured at inclusion, one month later and 2 months after the patients death.
Relative's experiences regarding the palliative treatment of the patient.
Measured: Will be measured at inclusion, one month later and 2 months after the patients death.
Subjective burden of relative (Burden Scale for Family Caregivers [BSFC]).
Measured: Will be measured at inclusion and one month later.
GPs evaluation of the terminal phase.
Measured: Will be measured after the patients death.
District nurses evaluation of the terminal phase.
Measured: Will be measured after the patients death.
Hospital doctors evaluation of the terminal phase.
Measured: Will be measured after the patients death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: Recruitment problems has forced us to change the design of this study from a clinical trial to a comparative study of 3 different groups of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, Aarhus University Hospital
- Investigators
- Frede Olesen, Professor, Study director, Research Unit for General Practice, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594971
- Sponsor's protocol ID
- 15273887
- Other IDs
- ISRCTN15273887
- Status last verified
- Jan 2011
- First submitted
- 7 Jan 2008
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Shared Care Approach for Seriously Ill Cancer Patients Between General Practice, Discharge Department and a Specialist Palliative Care Team
- ClinicalTrials.gov ID
- NCT00594971
- Acronym / sponsor ID
- 15273887
- Conditions
- Palliative Care, Neoplasms
- Keywords
- Health Services Research, Family practice
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment problems has forced us to change the design of this study from a clinical trial to a comparative study of 3 different groups of patients.
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, Aarhus University Hospital
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 16 Jan 2008 (estimated)
- 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.
Background:
Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and international research shows that the majority of terminally ill cancer patients wish to die at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has traditionally had the full responsibility for the palliative care of terminally ill cancer patients. In recent years changes have been made to the organisation of palliative care: some hospitals have set up specialised palliative care teams and in some areas of Denmark hospices have been established.
Recent research defines a problem when it comes to communication between the hospital and general practice when the patient is being discharged. This is often done in a way that can cause the patient to feel "left in limbo", especially if it is not completely clear to the patient and his or her relatives who has the responsibility for the palliative care.
Objective:
- To describe consequences for patients, relatives and health care professionals of three different ways of organising palliative care
- To collect data which describes patients who are candidates to a shared care approach between general practice and a specialised palliative care team
- To collect data which describes the palliative phase (place of death and palliative care, admissions to hospital, involvement of GP and district nurse etc.)
- To describe terminally ill cancer patients and their relatives expectations of the health care system
270 terminally ill cancer patients will be invited to take part in the study. Data will be collected by interview with patients and questionnaires for patients, relatives and involved health care professionals.
Detailed description
The intervention in the study is of organisational character. The patients will be randomised into two groups (groups B and C). A group of usual care patients will be included primary to the intervention (group A). The groups are:
- Usual discharge with regular discharge letter to the GP. The GP, together with the community nurse, is responsible for the palliative care, including referral to a specialist palliative care team, hospice, hospital, etc., if necessary
- Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care
- Discharge with extra effort put into improving the communication between the hospital and the GP. The GP will receive a phone call from the doctor who is discharging the patient, a detailed discharge letter, written information about the patient's type of cancer and acute oncological symptoms, name and phone number of the community nurse and name and phone number of a specialist in palliative medicine, who can be contacted for advice. This is a shared care model, where focus is on supporting the health care professionals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Other | Other: Referral to a specialist palliative care team.90 terminally ill cancer patients will be referred to a specialist palliative care team at time of discharge. |
| C | Other | Other: Organisational intervention90 terminally ill cancer patients will be discharged from hospital with extra effort put into improving the communication between the hospital and the primary sector. |
| A | No intervention | –90 terminally ill cancer patients will be discharged from hospital, receiving usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be included the patients have to be diagnosed as suffering from terminal cancer. The patients should also:
- Be 18 years or older
- Be able to speak and write Danish fluently
- Give written and spoken consent
- Be able to manage in their own home, with or without the help of carers and district nurses
Key exclusion criteria (5 listed)
- Have a low level of cognitive skills, which makes it difficult for them to fill in a questionnaire
- Are residents of a nursing home at the time of inclusion
- Are receiving oncologic treatment which requires attending an out-patients clinic regularly
- Already have established contact with a specialist palliative care team at the time of inclusion -
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 |
|---|---|---|
| Organisational interventionA shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector. | Other | C |
| Referral to a specialist palliative care team.Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care. | Other | B |
Primary outcome
Patients wish for place of death and place of terminal care fulfilled
Time frame: The patient will be asked about preference for place of death and place for terminal care at inclusion and a month later. At the time of death we will be able to establish weather the patient had his or her wishes fulfilled.
Relative amount of time spent in hospital in the terminal phase
Time frame: At the patients time of death we will be able to count number of days spent in hospital using the hospitals electronic patient files.
A subjective measure of the patients symptoms and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Palliative care [EORTC-QLQ-15-PAL])
Time frame: Will be measured at the time of inclusion and a month later.
9 secondary outcomes
Patient's satisfaction regarding the services of the GP, district nurse and local hospital
Time frame: Will be measured at inclusion and one month later.
Patient's experiences regarding cooperation and information sharing in the health care system.
Time frame: Will be measured at inclusion and one month later.
Relative's satisfaction regarding the services of the GP, district nurse and local hospital.
Time frame: Will be measured at inclusion, one month later and 2 months after the patients death.
Relative's experiences regarding cooperation and information sharing in the health care system.
Time frame: Will be measured at inclusion, one month later and 2 months after the patients death.
Relative's experiences regarding the palliative treatment of the patient.
Time frame: Will be measured at inclusion, one month later and 2 months after the patients death.
Subjective burden of relative (Burden Scale for Family Caregivers [BSFC]).
Time frame: Will be measured at inclusion and one month later.
GPs evaluation of the terminal phase.
Time frame: Will be measured after the patients death.
District nurses evaluation of the terminal phase.
Time frame: Will be measured after the patients death.
Hospital doctors evaluation of the terminal phase.
Time frame: Will be measured after the patients death.
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 11 Jan 2011.
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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.
Frede Olesen, Professor study director
Research Unit for General Practice, Aarhus University
Questions about this trial
What is this clinical trial studying?
A study testing Organisational intervention and Referral to a specialist palliative care team. in people with Palliative Care and Neoplasms, run by University of Aarhus.
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 7 inclusion and 5 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 11 Jan 2011. 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?
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?
Patients wish for place of death and place of terminal care fulfilled (time frame: The patient will be asked about preference for place of death and place for terminal care at inclusion and a month later. At the time of death we will be able to establish weather the patient had his or her wishes fulfilled.). The study lists 3 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 11 Jan 2011.