Prospective National Survey of the Palliative Situation Among Inmates in French Prisons

An observational study of Critical Illness and Terminal Illness, run by Centre Hospitalier Universitaire de Besancon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

PARME study had 3 objectives: To identify the specific number of incarcerated individuals with terminal illness in need of palliative care. To describe the health and penal situation of these prisoners. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Terminal Illness
What is being tested?: qualitative interview
How many people: 15 participants
Where: No sites listed yet
Study dates: May 2011to Dec 2013
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: Every prisonners with terminal illness

Who may be able to join

prisonners
serious and evolving pathology
vital prognosis less than a year

Who cannot join

less than 18 year
person under tutelage
patient who refuse to participate

About this study

PARME study had 3 objectives:

To identify the specific number of incarcerated individuals with terminal illness in need of palliative care.
To describe the health and penal situation of these prisoners.
To analyse the situation of these ill prisoners especially in the context of suspended sentence for medical ground

In order to answer these questions, the investigators used a mixed method research.

Read the detailed description

First, in order to establish a baseline, the investigators contacted the medical units in all French prisons, which means 178 care units and 8 secures inpatient care units. The investigators census every patient with terminal illness, which was defined in this study as an evolutive pathology with a life prognosis less than a year.

A questionnaire was completed by these physicians for every situation. The census was conducted for three months across France.

For the qualitative study, the investigators selected 14 specific situations chosen into these which had been identified by the physicians.

The investigators wanted to get 3 types of patients :

patient who had obtained a compassionate release
patient whose demand has been refused
patient who did not demand any release. The four interviews (patients, physisians, judges, probation workers) for each situation has explained the global situation.

Each interviewee spoke about the situation with his/her perspective and sense that they attributed to the actions of others.

This research analyzes the particularity of each of these end of life situations in prison.

Conditions: Critical Illness, Terminal Illness
Being tested: qualitative interview
Keywords: palliative care, vulnerable population, qualitative research
Medical subject headings: Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

qualitative interviewOther
some patient are interviewed.

Study groups in NCT02362295
Study group	Role	What they receive
census		qualitative interview Receives: Other: qualitative interview

What is being measured

The primary outcome is the main question the study is designed to answer.

census ill prisonners with vital prognosis less than a year and understand how penal and medical professional are coping with these situations
Measured: 1 year

Secondary outcomes (3)

uderstand how professionnels are coping with not condamned prisonners
Measured: 1 year
Question the meaning of the sentence for ill prisonners
Measured: 1 year
Compare the way professionnal are coping with these situation around France
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Dec 2013

First posted12 Feb 2015 (estimated)
Study startMay 2011
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de BesanconThe 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
Time perspective: Prospective
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02362295
Sponsor's protocol ID: 2011-A00791-40
Acronym: PARME
Status last verified: Feb 2015
First submitted: 9 Feb 2015
Last updated: 24 Feb 2015
Results posted: No
Data monitoring committee: Yes

Publications

AUBRY R., 2011, Etat des lieux du développement des soins palliatifs en France en 2010, Rapport à M. Le Président de la République, M. Le Premier Ministre, Comité national de suivi du développement des soins palliatifs.
BERTRAND D, NIVEAU G, 2006, Santé et Prison. Chêne-Bourg : Editions Médecine & Hygiène, 2006
Bolger M. Dying in prison: providing palliative care in challenging environments. Int J Palliat Nurs. 2005 Dec;11(12):619-20; discussion 621. doi: 10.12968/ijpn.2005.11.12.20227.
PubMed 16415753
Byock I. Dying well in corrections: why should we care? Correctcare. 2002 Fall;16(4):18. No abstract available.
PubMed 12705265
Chow RK. Initiating a long-term care nursing service for aging inmates. Geriatr Nurs. 2002 Jan-Feb;23(1):24-7. doi: 10.1067/mgn.2002.122562.
PubMed 11865254
Cohn F. The ethics of end-of-life care for prison inmates. J Law Med Ethics. 1999 Fall;27(3):252-9, 210. doi: 10.1111/j.1748-720x.1999.tb01459.x.
PubMed 11067602
DARBEDA P., mars-juin 1999, " Médecine et détenus ", Journal international de bioéthique, n°1-2, pp 35-45.
Drescher GP. Prisoner's right to refuse treatment outweighs physician's duty to treat. J Law Med Ethics. 1993 Fall-Winter;21(3-4):400-1. No abstract available.
PubMed 11654964
Dubler NN. The collision of confinement and care: end-of-life care in prisons and jails. J Law Med Ethics. 1998 Summer;26(2):149-56. doi: 10.1111/j.1748-720x.1998.tb01670.x. No abstract available.
PubMed 11657351
Finlay IG. Managing terminally ill prisoners: reflection and action. Palliat Med. 1998 Nov;12(6):457-61. doi: 10.1191/026921698674823377.
PubMed 10621866
Gallagher EM. Elders in prison. Health and well-being of older inmates. Int J Law Psychiatry. 2001 Mar-Jun;24(2-3):325-33. doi: 10.1016/s0160-2527(00)00080-7. No abstract available.
PubMed 11436633
Kiel RA. Caring for terminally ill inmates: on-site hospice care or compassionate release? Correctcare. 1995 Jun-Jul;9(2):5, 13-14. No abstract available.
PubMed 11660066
Lin J, Mathew P. Prison inmates and palliative care. JAMA. 2007 Dec 5;298(21):2481; author reply 2481. doi: 10.1001/jama.298.21.2481-a. No abstract available.
PubMed 18056900
Lincoln A. Improving the conditions of confinement. End-of-life care in prison. Pharos Alpha Omega Alpha Honor Med Soc. 2008 Autumn;71(4):18-25. No abstract available.
PubMed 19014115
Linder JF, Meyers FJ. Palliative care for prison inmates: "don't let me die in prison". JAMA. 2007 Aug 22;298(8):894-901. doi: 10.1001/jama.298.8.894.
PubMed 17712073

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Critical Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective National Survey of the Palliative Situation Among Inmates in French Prisons
ClinicalTrials.gov ID: NCT02362295
Acronym / sponsor ID: PARME / 2011-A00791-40
Conditions: Critical Illness, Terminal Illness
Keywords: palliative care, vulnerable population, qualitative research
Study type: Observational
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
Collaborators: Hospices Civils de Lyon, Central Hospital, Nancy, France, University Hospital, Lille, University Hospital, Marseille, University Hospital, Toulouse, University Hospital, Bordeaux, Rennes University Hospital, Assistance Publique - Hôpitaux de Paris
Study start: May 2011
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 12 Feb 2015 (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.

PARME study had 3 objectives:

To identify the specific number of incarcerated individuals with terminal illness in need of palliative care.
To describe the health and penal situation of these prisoners.
To analyse the situation of these ill prisoners especially in the context of suspended sentence for medical ground

In order to answer these questions, the investigators used a mixed method research.

Detailed description

A questionnaire was completed by these physicians for every situation. The census was conducted for three months across France.

For the qualitative study, the investigators selected 14 specific situations chosen into these which had been identified by the physicians.

The investigators wanted to get 3 types of patients :

patient who had obtained a compassionate release
patient whose demand has been refused
patient who did not demand any release. The four interviews (patients, physisians, judges, probation workers) for each situation has explained the global situation.

Each interviewee spoke about the situation with his/her perspective and sense that they attributed to the actions of others.

This research analyzes the particularity of each of these end of life situations in prison.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
census	–	Other: qualitative interviewqualitative interview

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Every prisonners with terminal illness

Key inclusion criteria (3 listed)

prisonners
serious and evolving pathology
vital prognosis less than a year

Key exclusion criteria (3 listed)

less than 18 year
person under tutelage
patient who refuse to participate

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
qualitative interviewsome patient are interviewed.	Other	census

Primary outcome

census ill prisonners with vital prognosis less than a year and understand how penal and medical professional are coping with these situations
Time frame: 1 year

3 secondary outcomes

uderstand how professionnels are coping with not condamned prisonners
Time frame: 1 year
Question the meaning of the sentence for ill prisonners
Time frame: 1 year
Compare the way professionnal are coping with these situation around France
Time frame: 1 year

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 24 Feb 2015.
BackgroundAUBRY R., 2011, Etat des lieux du développement des soins palliatifs en France en 2010, Rapport à M. Le Président de la République, M. Le Premier Ministre, Comité national de suivi du développement des soins palliatifs.
BackgroundBERTRAND D, NIVEAU G, 2006, Santé et Prison. Chêne-Bourg : Editions Médecine & Hygiène, 2006
Background: PubMed 16415753Bolger M. Dying in prison: providing palliative care in challenging environments. Int J Palliat Nurs. 2005 Dec;11(12):619-20; discussion 621. doi: 10.12968/ijpn.2005.11.12.20227.
Background: PubMed 12705265Byock I. Dying well in corrections: why should we care? Correctcare. 2002 Fall;16(4):18. No abstract available.
Background: PubMed 11865254Chow RK. Initiating a long-term care nursing service for aging inmates. Geriatr Nurs. 2002 Jan-Feb;23(1):24-7. doi: 10.1067/mgn.2002.122562.
Background: PubMed 11067602Cohn F. The ethics of end-of-life care for prison inmates. J Law Med Ethics. 1999 Fall;27(3):252-9, 210. doi: 10.1111/j.1748-720x.1999.tb01459.x.
BackgroundDARBEDA P., mars-juin 1999, " Médecine et détenus ", Journal international de bioéthique, n°1-2, pp 35-45.
Background: PubMed 11654964Drescher GP. Prisoner's right to refuse treatment outweighs physician's duty to treat. J Law Med Ethics. 1993 Fall-Winter;21(3-4):400-1. No abstract available.
Background: PubMed 11657351Dubler NN. The collision of confinement and care: end-of-life care in prisons and jails. J Law Med Ethics. 1998 Summer;26(2):149-56. doi: 10.1111/j.1748-720x.1998.tb01670.x. No abstract available.
Background: PubMed 10621866Finlay IG. Managing terminally ill prisoners: reflection and action. Palliat Med. 1998 Nov;12(6):457-61. doi: 10.1191/026921698674823377.
Background: PubMed 11436633Gallagher EM. Elders in prison. Health and well-being of older inmates. Int J Law Psychiatry. 2001 Mar-Jun;24(2-3):325-33. doi: 10.1016/s0160-2527(00)00080-7. No abstract available.
Background: PubMed 11660066Kiel RA. Caring for terminally ill inmates: on-site hospice care or compassionate release? Correctcare. 1995 Jun-Jul;9(2):5, 13-14. No abstract available.

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RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

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.

Edouard Amzallag, Dr principal investigator

Hospices Civils de Lyon

Sebastien Grignard, Dr principal investigator

Centre Hospitalier Universitaire de Besancon

Blanchet Emmanuelle, Dr principal investigator

Central Hospital, Nancy, France

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Terminal Illness, run by Centre Hospitalier Universitaire de Besancon.

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 3 inclusion and 3 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 24 Feb 2015. 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.

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?

census ill prisonners with vital prognosis less than a year and understand how penal and medical professional are coping with these situations (time frame: 1 year). 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 NCT02362295, which also lists 35 linked publications.

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 24 Feb 2015.