Palliative CareNCT02091622
Increasing the Number of Patients Receiving Information About Transition to End-of-life Care
A study testing Educative intervention in people with Palliative Care and Disclosure, run by Umeå University at 1 site in Sweden.
Trial summary
Introduction: Honest prognostication and information for patients are important parts of end-of-life care. This study examined whether an educational intervention could increase the proportion of patients who received information about the transition to end-of-life care (ITEOL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Disclosure
- What is being tested?
- Educative intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,431 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Oct 2012
- 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
- Hospitals and municipalities: Participation in the Swedish Register of Palliative Care.
- Patients: Reported from an included hospital or municipality during six months before to six months after intervention.
Who cannot join
- Hospitals and municipalities: Exclusion criteria were more than 40% patients receiving ITEOL at start of study, too large for an intervention due to practical reasons (university hospitals or municipalities with over 100 000 inhabitants), and hospitals not containing both internal medicine and surgery departments.
- Patients were excluded when death was unexpected, when a forensic post mortem examination was performed, or when the patients had lost their ability to express their will and take part in decisions concerning the content of medical care one week or more before death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing the Number of Patients Receiving Information About Transition to End-of-life Care: the Effect of a Half-day Physician and Nurse Training
Introduction: Honest prognostication and information for patients are important parts of end-of-life care. This study examined whether an educational intervention could increase the proportion of patients who received information about the transition to end-of-life care (ITEOL).
Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Patients were only included if they died an expected death and maintained their ability to express their will until days or hours before their death. Four hospitals and four municipalities were assigned controls, matched by hospital size, population, and proportion of patients receiving ITEOL at baseline.
- Conditions
- Palliative Care, Disclosure
- Being tested
- Educative intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educative interventionOther
Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses.
| Study group | Role | What they receive |
|---|---|---|
| Educative intervention | Other | Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. Receives: Other: Educative intervention |
| No intervention | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who received ITEOL
The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Six months after the intervention data were collected from the SRPC for all patients who had died at the included hospitals and municipalities. Data were collected from six months before the intervention to six months after the intervention. The outcome was compared before and after the intervention.
Measured: Six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Umeå UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertil Axelsson, MD PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091622
- Sponsor's protocol ID
- Intervention-sv-pall
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Number of Patients Receiving Information About Transition to End-of-life Care: the Effect of a Half-day Physician and Nurse Training
- ClinicalTrials.gov ID
- NCT02091622
- Acronym / sponsor ID
- Intervention-sv-pall
- Conditions
- Palliative Care, Disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,431 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Mar 2014 (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.
Introduction: Honest prognostication and information for patients are important parts of end-of-life care. This study examined whether an educational intervention could increase the proportion of patients who received information about the transition to end-of-life care (ITEOL).
Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Patients were only included if they died an expected death and maintained their ability to express their will until days or hours before their death. Four hospitals and four municipalities were assigned controls, matched by hospital size, population, and proportion of patients receiving ITEOL at baseline.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educative intervention | Other | Other: Educative interventionTwo municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. |
| No intervention | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitals and municipalities: Participation in the Swedish Register of Palliative Care.
- Patients: Reported from an included hospital or municipality during six months before to six months after intervention.
Key exclusion criteria (2 listed)
- Hospitals and municipalities: Exclusion criteria were more than 40% patients receiving ITEOL at start of study, too large for an intervention due to practical reasons (university hospitals or municipalities with over 100 000 inhabitants), and hospitals not containing both internal medicine and surgery departments.
- Patients were excluded when death was unexpected, when a forensic post mortem examination was performed, or when the patients had lost their ability to express their will and take part in decisions concerning the content of medical care one week or more before death.
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 |
|---|---|---|
| Educative interventionTwo municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. | Other | Educative intervention |
Primary outcome
The proportion of patients who received ITEOL
Time frame: Six months after intervention
The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Six months after the intervention data were collected from the SRPC for all patients who had died at the included hospitals and municipalities. Data were collected from six months before the intervention to six months after the intervention. The outcome was compared before and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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.
Bertil Axelsson, MD PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educative intervention in people with Palliative Care and Disclosure, run by Umeå University 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 2 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: finished, as of the sponsor's last update on 19 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients who received ITEOL (time frame: Six months after intervention). 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 19 Mar 2014.