Cessation of LifeNCT02822690
Research Into the Quality of the Dying Phase
An observational study of Cessation of Life, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim of this study is to get insight in the quality of life at the end of life and quality of dying for patients died at the hospital in the department Groningen (the Netherlands). The primary endpoint is the quality of life at the end of life and the secondary endpoint is the quality of dying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cessation of Life
- What is being tested?
- Hospice care at UMCG
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to Jun 2019
- Phase
- Observational
- 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
Study population: all patients dying in the hospital
Who may be able to join
- patients dying in the hospital
Who cannot join
- patients dying at the child ward, emergency dept. and intensive care dept.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Into the Quality of the Dying Phase in Hospitals in the Province of Groningen
The aim of this study is to get insight in the quality of life at the end of life and quality of dying for patients died at the hospital in the department Groningen (the Netherlands).
The primary endpoint is the quality of life at the end of life and the secondary endpoint is the quality of dying. Both according a numerical rating scale.
An explorative analysis will be done for differences for the hospitals in Groningen, effect of using the Liverpool care Pathway for the dying, effect of using consultation by the palliative consultation team, effect of using the Hospice@UMCG intervention, correlation with the quality of life at the end of life and quality of dying according to nurses and doctors.
Read the detailed description
Three hospitals in the department Groningen (the Netherlands) will participate in this study. When a patient died in one of these hospitals (except the emergency department, child ward and intensive care unit) the bereaved relatives will get an information letter. After about 12 weeks a questionnaire will be sent to the bereaved relative. This questionnaire is developed to evaluate the end of life care at the hospital.
Shortly after the patient died at the hospital, also the nurse and doctor of this patient are requested to fill out a questionnaire.
The questionnaire for the bereaved relatives consists of items, divided in groups: a general part, followed by questions of the last days of life, existing symptoms (physical, psychological, existential and social), the care and treatment and the loss.
The questionnaire for the nurses exists of similar items. Special attention for recognizing the impending dying and problems, care and therapy at the end of life.
In all questionnaires there are also 2 main questions: What is your opinion of the quality of life during the last days of life and What is your opinion of the quality of dying.
In the three hospitals the end of life care is managed at somehow different ways: the use of the Liverpool care Pathway of the dying, the hospice@UMCG intervention and consultation by the palliative team of the hospital.
- Conditions
- Cessation of Life
- Being tested
- Hospice care at UMCG
- Keywords
- palliative care, Quality of dying
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospice care at UMCGOther
introduction of hospice care facilities on the wards at the UMCG
| Study group | Role | What they receive |
|---|---|---|
| University Medical Center Groningen | all patients that died on one of the wards with the exception of children; on several wards the Hospice care will be introduced as an intervention Receives: Other: Hospice care at UMCG | |
| Martini Ziekenhuis | all patients that died on one of the wards with the exception of children | |
| Ommelander ZorgGroep | all patients that died on one of the wards with the exception of children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cessation of LifeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Sponsor
- Investigators
- An KL Reyners, MD/PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822690
- Sponsor's protocol ID
- 2016pz/1
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2016
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Into the Quality of the Dying Phase in Hospitals in the Province of Groningen
- ClinicalTrials.gov ID
- NCT02822690
- Acronym / sponsor ID
- 2016pz/1
- Conditions
- Cessation of Life
- Keywords
- palliative care, Quality of dying
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- Oct 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 Jul 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.
The aim of this study is to get insight in the quality of life at the end of life and quality of dying for patients died at the hospital in the department Groningen (the Netherlands).
The primary endpoint is the quality of life at the end of life and the secondary endpoint is the quality of dying. Both according a numerical rating scale.
An explorative analysis will be done for differences for the hospitals in Groningen, effect of using the Liverpool care Pathway for the dying, effect of using consultation by the palliative consultation team, effect of using the Hospice@UMCG intervention, correlation with the quality of life at the end of life and quality of dying according to nurses and doctors.
Detailed description
Three hospitals in the department Groningen (the Netherlands) will participate in this study. When a patient died in one of these hospitals (except the emergency department, child ward and intensive care unit) the bereaved relatives will get an information letter. After about 12 weeks a questionnaire will be sent to the bereaved relative. This questionnaire is developed to evaluate the end of life care at the hospital.
Shortly after the patient died at the hospital, also the nurse and doctor of this patient are requested to fill out a questionnaire.
The questionnaire for the bereaved relatives consists of items, divided in groups: a general part, followed by questions of the last days of life, existing symptoms (physical, psychological, existential and social), the care and treatment and the loss.
The questionnaire for the nurses exists of similar items. Special attention for recognizing the impending dying and problems, care and therapy at the end of life.
In all questionnaires there are also 2 main questions: What is your opinion of the quality of life during the last days of life and What is your opinion of the quality of dying.
In the three hospitals the end of life care is managed at somehow different ways: the use of the Liverpool care Pathway of the dying, the hospice@UMCG intervention and consultation by the palliative team of the hospital.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| University Medical Center Groningen | – | Other: Hospice care at UMCGall patients that died on one of the wards with the exception of children; on several wards the Hospice care will be introduced as an intervention |
| Martini Ziekenhuis | – | –all patients that died on one of the wards with the exception of children |
| Ommelander ZorgGroep | – | –all patients that died on one of the wards with the exception of children |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients dying in the hospital
Key inclusion criteria (1 listed)
- patients dying in the hospital
Key exclusion criteria (1 listed)
- patients dying at the child ward, emergency dept. and intensive care dept.
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 |
|---|---|---|
| Hospice care at UMCGintroduction of hospice care facilities on the wards at the UMCG | Other | University Medical Center Groningen |
Primary outcome
Quality of life questionnaire
Time frame: 2 years
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 Apr 2024.
- Individual participant dataSharing planned: No
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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.
An KL Reyners, MD/PhD principal investigator
University Medical Center Groningen
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 Cessation of Life, run by University Medical Center Groningen at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 19 Apr 2024. 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 Netherlands. 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?
Quality of life questionnaire (time frame: 2 years). 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 Apr 2024.