Palliative Care NursingPERCEPALNCT02900573
Withdrawal of Artificial Nutrition at the End of Life (PERCEPAL)
An observational study of Palliative Care Nursing, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care Nursing
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Aug 2010
- 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: Senior nurses (which are not directly in contact with the patient but involved in team management), nurses (which perform patient care), and nurses' aides (which are involved in hygiene measures) working in the medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville.
Who may be able to join
- nurses, and nurses' aides working in medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville
Who cannot join
- Care providers working in pediatrics, gynecology and obstetrics, psychiatry, and emergency departments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caregivers Confronted With the Withdrawal of Artificial Nutrition at the End of Life: Perception and Experienced Difficulties
Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.
Read the detailed description
The benefit of artificial nutrition in terminally ill patients has been a highly debated issue for the past 30 years, and abundant data are available regarding its effects on patients. Several clinical guidelines have specified the criteria to be considered before initiating artificial nutrition or hydration. If these guidelines appear consensual in theory, the situation is much less straightforward in practice. The attitude of physicians appeared very variable when it came to prescribing or withholding artificial nutrition or hydration, and the lack of training, among other parameters, seemingly encouraged health care professionals to prescribe artificial nutrition or hydration. Furthermore, the decision of the care provider is unconsciously complicated due to figurative representations associated with food regarding, among other aspects, the mother-child relationship, social cohesion, or religious beliefs.
These differences are more important since the opinion of physicians and nurses is the one that carries the most influence on the patients' decision when deciding to initiate artificial nutrition and because artificial nutrition and hydration are a common source of ethical dilemmas in health care teams. Furthermore, stopping artificial nutrition or hydration could be misconstrued as euthanasia.
- Conditions
- Palliative Care Nursing
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of health care providers confronted with the withdrawing of artificial nutrition at the end of life
Cross-sectional survey questionnaire
Measured: month 4
Secondary outcomes (1)
Experienced difficulties
Cross-sectional survey questionnaire
Measured: month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative Care NursingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît LEHEUP, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900573
- Sponsor's protocol ID
- 2010-01Obs-CHRMT
- Acronym
- PERCEPAL
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 14 Sep 2016
- 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 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers Confronted With the Withdrawal of Artificial Nutrition at the End of Life: Perception and Experienced Difficulties
- ClinicalTrials.gov ID
- NCT02900573
- Acronym / sponsor ID
- PERCEPAL / 2010-01Obs-CHRMT
- Conditions
- Palliative Care Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Sep 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.
Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.
Detailed description
The benefit of artificial nutrition in terminally ill patients has been a highly debated issue for the past 30 years, and abundant data are available regarding its effects on patients. Several clinical guidelines have specified the criteria to be considered before initiating artificial nutrition or hydration. If these guidelines appear consensual in theory, the situation is much less straightforward in practice. The attitude of physicians appeared very variable when it came to prescribing or withholding artificial nutrition or hydration, and the lack of training, among other parameters, seemingly encouraged health care professionals to prescribe artificial nutrition or hydration. Furthermore, the decision of the care provider is unconsciously complicated due to figurative representations associated with food regarding, among other aspects, the mother-child relationship, social cohesion, or religious beliefs.
These differences are more important since the opinion of physicians and nurses is the one that carries the most influence on the patients' decision when deciding to initiate artificial nutrition and because artificial nutrition and hydration are a common source of ethical dilemmas in health care teams. Furthermore, stopping artificial nutrition or hydration could be misconstrued as euthanasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Senior nurses (which are not directly in contact with the patient but involved in team management), nurses (which perform patient care), and nurses' aides (which are involved in hygiene measures) working in the medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville.
Key inclusion criteria (1 listed)
- nurses, and nurses' aides working in medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville
Key exclusion criteria (1 listed)
- Care providers working in pediatrics, gynecology and obstetrics, psychiatry, and emergency departments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experience of health care providers confronted with the withdrawing of artificial nutrition at the end of life
Time frame: month 4
Cross-sectional survey questionnaire
1 secondary outcome
Experienced difficulties
Time frame: month 4
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 14 Sep 2016.
- 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.
Benoît LEHEUP, MD principal investigator
CHR Metz-Thionville
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 Palliative Care Nursing, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 14 Sep 2016. 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 France. 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?
Experience of health care providers confronted with the withdrawing of artificial nutrition at the end of life (time frame: month 4). 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 14 Sep 2016.