Life-threatening IllnessPhase 2NCT02775032
Initiating ACP in General Practice. A Phase II Study
A Phase 2 study testing Advance care planning conversations between patients and their GP in people with Life-threatening Illness and Palliative, run by Vrije Universiteit Brussel.
Trial summary
End-of-life care often fails in providing optimal patient-centred care and quality of life. Patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life-threatening Illness, Palliative
- What is being tested?
- Advance care planning conversations between patients and their GP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- patients with a serious or life-threatening illness
- older than 18 years
- Dutch speaking
- eligible according to the Surprise question
- able to give informed consent
- able to complete questionnaires and participate in qualitative interview
Who cannot join
- younger than 18 years
- incompetent to participate due to mental incapacity
- unable to give informed consent
- unable to complete questionnaires or participate in qualitative interviews
About this study
Official title: Evaluation of a Complex Intervention to Initiate Advance Care Planning in General Practice for the Improvement of End-of-life Care
End-of-life care often fails in providing optimal patient-centred care and quality of life. Patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. Advance care planning (ACP) can tackle these problems by providing patients with an opportunity to formulate their wishes and plan their future care, should they become incapable of participating in medical treatment decisions. Previous studies show that ACP improves concordance between patient's preferences and end-of-life care received and quality of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP with their patients. By introducing ACP during a routine office visit, GPs can facilitate a structured discussion of the patient's wishes for end-of-life care. However, no ACP models have been systematically developed and tested in general practice. We developed a complex intervention to improve the initiation of ACP in general practice following the steps of an international guidance for development and evaluation of complex interventions. Before performing a full-scale intervention trial to study the effectiveness of this intervention on quality of care and quality of life, this model needs to be validated and tested in a pilot trial.
Read the detailed description
Aim
- to conduct the Phase II trial with GPs who will facilitate a structured ACP session with patients with a serious or life-threatening illness versus usual care and 2) to evaluate and validate the ACP intervention in terms of feasibility, acceptance to GPs and patients with a serious or life-threatening illness, and preliminary proof of effectiveness
Method
The implementation and preliminary evaluation of this intervention will be done by following the steps of the Medical Research Council (MRC) framework on complex intervention designs. This framework proposes a stepwise approach going from phase 0 to phase IV.
Phase 0-I were previously conducted by the research team and comprised the development of the intervention. This project proposal comprises phase II (exploratory trial) in which the feasibility and acceptability of the intervention will be evaluated.
- Conditions
- Life-threatening Illness, Palliative
- Being tested
- Advance care planning conversations between patients and their GP
- Keywords
- advance care planning, general practice, family practice, palliative care, end-of-life care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning conversations between patients and their GPBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Life-threatening IllnessStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline De Vleminck, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775032
- Sponsor's protocol ID
- VZP_HA_2016
- Status last verified
- May 2016
- First submitted
- 13 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
Publications
Dierickx S, Pardon K, Pype P, Stevens J, Vander Stichele R, Deliens L, De Vleminck A. 'Advance care planning, general practitioners and patients: a phase II cluster-randomised controlled trial in chronic life-limiting illness'. BMJ Support Palliat Care. 2020 Dec 2:bmjspcare-2020-002712. doi: 10.1136/bmjspcare-2020-002712. Online ahead of print.
PubMed 33268475
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Complex Intervention to Initiate Advance Care Planning in General Practice for the Improvement of End-of-life Care
- ClinicalTrials.gov ID
- NCT02775032
- Acronym / sponsor ID
- VZP_HA_2016
- Conditions
- Life-threatening Illness, Palliative
- Keywords
- advance care planning, general practice, family practice, palliative care, end-of-life care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 May 2016 (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.
End-of-life care often fails in providing optimal patient-centred care and quality of life. Patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. Advance care planning (ACP) can tackle these problems by providing patients with an opportunity to formulate their wishes and plan their future care, should they become incapable of participating in medical treatment decisions. Previous studies show that ACP improves concordance between patient's preferences and end-of-life care received and quality of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP with their patients. By introducing ACP during a routine office visit, GPs can facilitate a structured discussion of the patient's wishes for end-of-life care. However, no ACP models have been systematically developed and tested in general practice. We developed a complex intervention to improve the initiation of ACP in general practice following the steps of an international guidance for development and evaluation of complex interventions. Before performing a full-scale intervention trial to study the effectiveness of this intervention on quality of care and quality of life, this model needs to be validated and tested in a pilot trial.
Detailed description
Aim
- to conduct the Phase II trial with GPs who will facilitate a structured ACP session with patients with a serious or life-threatening illness versus usual care and 2) to evaluate and validate the ACP intervention in terms of feasibility, acceptance to GPs and patients with a serious or life-threatening illness, and preliminary proof of effectiveness
Method
The implementation and preliminary evaluation of this intervention will be done by following the steps of the Medical Research Council (MRC) framework on complex intervention designs. This framework proposes a stepwise approach going from phase 0 to phase IV.
Phase 0-I were previously conducted by the research team and comprised the development of the intervention. This project proposal comprises phase II (exploratory trial) in which the feasibility and acceptability of the intervention will be evaluated.
Study design
- Primary purpose
- Health services research
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with a serious or life-threatening illness
- older than 18 years
- Dutch speaking
- eligible according to the Surprise question
- able to give informed consent
Key exclusion criteria (4 listed)
- younger than 18 years
- incompetent to participate due to mental incapacity
- unable to give informed consent
- unable to complete questionnaires or participate in qualitative interviews
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 |
|---|---|---|
| Advance care planning conversations between patients and their GP | Behavioural | – |
Primary outcome
Quality of life questionnaire
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 33268475Dierickx S, Pardon K, Pype P, Stevens J, Vander Stichele R, Deliens L, De Vleminck A. 'Advance care planning, general practitioners and patients: a phase II cluster-randomised controlled trial in chronic life-limiting illness'. BMJ Support Palliat Care. 2020 Dec 2:bmjspcare-2020-002712. doi: 10.1136/bmjspcare-2020-002712. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Advance care planning conversations between patients and their GP in people with Life-threatening Illness and Palliative, run by Vrije Universiteit Brussel.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 May 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Quality of life questionnaire (time frame: up to 1 month). 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 NCT02775032, 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 17 May 2016.