Chronic Obstructive Pulmonary DiseaseNCT02050256
Improving End-of-life Care by Continuing Medical Education and Electronic Decision Making Support for General Practitioners
A study testing continuing medical education and electronic decision support and education and electronic support in people with Chronic Obstructive Pulmonary Disease and Metastatic Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Optimizing the basic palliative care has been shown beneficial to patients in end-of-life care, the general practitioner (GP) having a pivotal role in the health care system, providing comprehensive and continued medical care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Metastatic Cancer
- What is being tested?
- continuing medical education and electronic decision support and education and electronic support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 2014
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Working as General Practitioner in the Central Region of Denmark in 2013 and onwards
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving End-of-life Care by Continuing Medical Education and Electronic Decision Making Support for General Practitioners in Denmark - an Intervention Study
Background: Optimizing the basic palliative care has been shown beneficial to patients in end-of-life care, the general practitioner (GP) having a pivotal role in the health care system, providing comprehensive and continued medical care.
The aim of the study is to investigate the effect of a complex intervention in general practice on GPs' awareness of and confidence in providing end-of-life care.
Read more
Method: A follow-up study among 404 general practices in Central Denmark Region. The participating general practices will get the opportunity to receive education in palliative care and access to an electronic support, which provides advice on palliative care and an overview of the palliative population in each medical practice. The education and the support will focus on patients suffering from either metastatic cancer or chronic obstructive pulmonary disease (GOLD stage 4).
The end-of-life care delivered by the GPs to their deceased patients will be analysed, based on questionnaires to GPs and register data related to the deceased patients before and after the intervention, .
Primary outcomes: Place of death of deceased patients, time spent at home, and number of hospital admissions in the last three months of the patients' lives.
Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be assessed in questionnaires.
- Being tested
- continuing medical education and electronic decision support, education and electronic support
- Keywords
- Palliative care, Continuing medical education, General practitioner, Electronic decision support
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuing medical education and electronic decision supportOther
education and electronic supportOther
Continuing medical education and electronic decision support to General Practitioners.
| Study group | Role | What they receive |
|---|---|---|
| general practioner | Other | Not described Receives: Other: continuing medical education and electronic decision support; Other: education and electronic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Place of death of deceased patients
Looking at the proportion of General practitioners patients dying at home in the year following the continuing medical education meeting
Measured: 1 year
time spent at home the last three months of the deceased patients lives
Looking at all the deceased patients in one year following the continuing medical education meeting
Measured: 3 months
Numbers of hospital admission the last three months of the deceased patients lives
Looking at all the deceased patients in one year following the continuing medical education meeting
Measured: 3 months
Secondary outcomes (3)
and kinds of contacts between GPs and patients in the last three months of the deceased patients lives
Measured: three months
use of relevant medicine and of the 'Safety Box' in the last three months of the deceased patients lives
Measured: three months
GPs' confidence concerning palliative care
assessed using questionnaire before and after the intervention
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: due to organisational changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Anders B. Mr Jensen, Professor, Principal investigator, Department of Oncology, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050256
- Sponsor's protocol ID
- 2006802748
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Winthereik AK, Neergaard MA, Jensen AB, Vedsted P. Development, modelling, and pilot testing of a complex intervention to support end-of-life care provided by Danish general practitioners. BMC Fam Pract. 2018 Jun 20;19(1):91. doi: 10.1186/s12875-018-0774-x.
PubMed 29925332
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving End-of-life Care by Continuing Medical Education and Electronic Decision Making Support for General Practitioners in Denmark - an Intervention Study
- ClinicalTrials.gov ID
- NCT02050256
- Acronym / sponsor ID
- 2006802748
- Keywords
- Palliative care, Continuing medical education, General practitioner, Electronic decision support
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to organisational changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society, TrygFonden, Denmark
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jan 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.
Background: Optimizing the basic palliative care has been shown beneficial to patients in end-of-life care, the general practitioner (GP) having a pivotal role in the health care system, providing comprehensive and continued medical care.
The aim of the study is to investigate the effect of a complex intervention in general practice on GPs' awareness of and confidence in providing end-of-life care.
Method: A follow-up study among 404 general practices in Central Denmark Region. The participating general practices will get the opportunity to receive education in palliative care and access to an electronic support, which provides advice on palliative care and an overview of the palliative population in each medical practice. The education and the support will focus on patients suffering from either metastatic cancer or chronic obstructive pulmonary disease (GOLD stage 4).
The end-of-life care delivered by the GPs to their deceased patients will be analysed, based on questionnaires to GPs and register data related to the deceased patients before and after the intervention, .
Primary outcomes: Place of death of deceased patients, time spent at home, and number of hospital admissions in the last three months of the patients' lives.
Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be assessed in questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general practioner | Other | Other: continuing medical education and electronic decision support, Other: education and electronic support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Working as General Practitioner in the Central Region of Denmark in 2013 and onwards
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| continuing medical education and electronic decision support | Other | general practioner |
| education and electronic supportContinuing medical education and electronic decision support to General Practitioners. | Other | general practioner |
Primary outcome
Place of death of deceased patients
Time frame: 1 year
Looking at the proportion of General practitioners patients dying at home in the year following the continuing medical education meeting
time spent at home the last three months of the deceased patients lives
Time frame: 3 months
Looking at all the deceased patients in one year following the continuing medical education meeting
Numbers of hospital admission the last three months of the deceased patients lives
Time frame: 3 months
Looking at all the deceased patients in one year following the continuing medical education meeting
3 secondary outcomes
and kinds of contacts between GPs and patients in the last three months of the deceased patients lives
Time frame: three months
use of relevant medicine and of the 'Safety Box' in the last three months of the deceased patients lives
Time frame: three months
GPs' confidence concerning palliative care
Time frame: 14 months
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 Dec 2014.
- Derived from this study: PubMed 29925332Winthereik AK, Neergaard MA, Jensen AB, Vedsted P. Development, modelling, and pilot testing of a complex intervention to support end-of-life care provided by Danish general practitioners. BMC Fam Pract. 2018 Jun 20;19(1):91. doi: 10.1186/s12875-018-0774-x.
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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.
Anders B. Mr Jensen, Professor principal investigator
Department of Oncology, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuing medical education and electronic decision support and education and electronic support in people with Chronic Obstructive Pulmonary Disease and Metastatic Cancer, run by University of Aarhus at 1 site in Denmark.
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 1 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 Dec 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 Denmark. 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?
Place of death of deceased patients (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT02050256, which also lists 1 linked publication.
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 Dec 2014.