GeriatricsNCT02682979
Continuity of the Therapeutic Limitation Code: Analysis of the Variables of Admission in the Emergency Service That Are Associated With a Therapeutic Limitation Upon Exit
An observational study of Geriatrics, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatrics
- What is being tested?
- Medical files analysis
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2016to 1 Dec 2017
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 100 consecutive geriatric patients admitted in the emergency department of the Brugmann Hospital, Horta site, from 01/04/2015 till 11/02/2016.
Who may be able to join
- Patients admitted in the hospital via the emergency department and placed in a nursing home upon hospital discharge
- Patients will an available global geriatric evaluation (either realized in the geriatric ward, either realized by the geriatric team)
Who cannot join
- if multiple hospitalizations occur during the study length, data related to the first hospitalization only will be analyzed.
Trial locations and contacts
1 site in 1 country.
About this study
Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services.
Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code.
Read more
As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered.
The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department.
Read the detailed description
Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services. The multidisciplinary care they need takes time.
Several options are investigated worldwide to properly manage these fragile patients:
- Scales of frailty and functional decline screening
- Specialized care units: the Mobile Geriatric Team, the Emergency short-stay units, the acute care geriatric unit, the geriatric nurse liaison model, or a service specific geriatric emergency.
Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code.
As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered.
The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department.
Furthermore, this study offers the prospective to establish in the future a systematic implementation of the therapeutic limitation code for geriatric patients residing in nursing homes, therefore anticipating the various issues specific to his population in the emergency department.
- Conditions
- Geriatrics
- Being tested
- Medical files analysis
- Keywords
- therapeutic limitation code, emergency unit admittance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical files analysisOther
Retrospective analysis of the medical files according to medical, social and geriatric criteria.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patients | 100 consecutive geriatric patients admitted in the Emergency Department of the Brugmann Hospital, Horta site, from 01/04/2015. Receives: Other: Medical files analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of a therapeutic limitation code (hospital admittance)
The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if they had a therapeutic limitation code upon admittance.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Prevalence of a therapeutic limitation code (hospital discharge)
The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if received a therapeutic limitation code upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Secondary outcomes (9)
social status
Retrospective analysis of patient medical files. The investigators will evaluate if the social status of the patient is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
autonomy status
Retrospective analysis of patient medical files.The investigators will evaluate if the autonomy of the patient is linked to a therapeutic limitation decision upon hospital discharge. Patient autonomy is evaluated by the results of either of these two tests: the Sherpa test or the Katz scale.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
cognitive status
Retrospective analysis of patient medical files.The investigators will evaluate if the cognitive status of the patient is linked to a therapeutic limitation decision upon hospital discharge. The patient cognitive status is evaluated by the results of either the confusion assessment method or the mini mental state evaluation test.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
diagnosis
Retrospective analysis of patient medical files.The investigators will evaluate if the admission motive/established diagnosis is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
hospitalisation length
Retrospective analysis of patient medical files.The investigators will evaluate if the hospitalisation length is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hopitalized from 01/04/2015 till present date (11 months)
Albumine
Retrospective analysis of patient medical files.The investigators will evaluate if the nutrition status (albumine measurement) is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Hydratation level
Retrospective analysis of patient medical files.The investigators will evaluate if the hydration level (combined sodium and creatinine/urea measurement) is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Unintentional weigh loss
Retrospective analysis of patient medical files.The investigators will evaluate if an unintentional weigh loss is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Presence of comorbidities
Retrospective analysis of patient medical files.The investigators will evaluate if the presence of comorbidities (dementia or severe cardiac decompensation or cancer or pneumonia or severe cardio-vascular diseases or hepatic insufficiency) is linked to a therapeutic limitation decision upon hospital discharge.
Measured: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Murielle Surquin, MD, Principal investigator, CHU BrugmannAxelle Gregory, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682979
- Sponsor's protocol ID
- CHUB-Therapeutic limitations
- Status last verified
- Jan 2018
- First submitted
- 11 Feb 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.
PubMed 6860082Yesavage JA. Geriatric Depression Scale. Psychopharmacol Bull. 1988;24(4):709-11. No abstract available.
PubMed 3249773Clement JP, Nassif RF, Leger JM, Marchan F. [Development and contribution to the validation of a brief French version of the Yesavage Geriatric Depression Scale]. Encephale. 1997 Mar-Apr;23(2):91-9. French.
PubMed 9264935Goring H, Baldwin R, Marriott A, Pratt H, Roberts C. Validation of short screening tests for depression and cognitive impairment in older medically ill inpatients. Int J Geriatr Psychiatry. 2004 May;19(5):465-71. doi: 10.1002/gps.1115.
PubMed 15156548Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
PubMed 6418786Katz PR, Karuza J, Kolassa J, Hutson A. Medical practice with nursing home residents: results from the National Physician Professional Activities Census. J Am Geriatr Soc. 1997 Aug;45(8):911-7. doi: 10.1111/j.1532-5415.1997.tb02958.x.
PubMed 9256840Katz PP, Yelin EH. Activity loss and the onset of depressive symptoms: do some activities matter more than others? Arthritis Rheum. 2001 May;44(5):1194-202. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-6.
PubMed 11352254Katz PP, Morris A. Use of accommodations for valued life activities: prevalence and effects on disability scores. Arthritis Rheum. 2007 Jun 15;57(5):730-7. doi: 10.1002/art.22765.
PubMed 17530671Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French.
PubMed 10399508
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuity of the Therapeutic Limitation Code: Analysis of the Variables of Admission in the Emergency Service That Are Associated With a Therapeutic Limitation Upon Exit
- ClinicalTrials.gov ID
- NCT02682979
- Acronym / sponsor ID
- CHUB-Therapeutic limitations
- Conditions
- Geriatrics
- Keywords
- therapeutic limitation code, emergency unit admittance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 Feb 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.
Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services.
Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code.
As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered.
The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department.
Detailed description
Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services. The multidisciplinary care they need takes time.
Several options are investigated worldwide to properly manage these fragile patients:
- Scales of frailty and functional decline screening
- Specialized care units: the Mobile Geriatric Team, the Emergency short-stay units, the acute care geriatric unit, the geriatric nurse liaison model, or a service specific geriatric emergency.
Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code.
As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered.
The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department.
Furthermore, this study offers the prospective to establish in the future a systematic implementation of the therapeutic limitation code for geriatric patients residing in nursing homes, therefore anticipating the various issues specific to his population in the emergency department.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients | – | Other: Medical files analysis100 consecutive geriatric patients admitted in the Emergency Department of the Brugmann Hospital, Horta site, from 01/04/2015. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 100 consecutive geriatric patients admitted in the emergency department of the Brugmann Hospital, Horta site, from 01/04/2015 till 11/02/2016.
Key inclusion criteria (2 listed)
- Patients admitted in the hospital via the emergency department and placed in a nursing home upon hospital discharge
- Patients will an available global geriatric evaluation (either realized in the geriatric ward, either realized by the geriatric team)
Key exclusion criteria (1 listed)
- if multiple hospitalizations occur during the study length, data related to the first hospitalization only will be analyzed.
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 |
|---|---|---|
| Medical files analysisRetrospective analysis of the medical files according to medical, social and geriatric criteria. | Other | Geriatric patients |
Primary outcome
Prevalence of a therapeutic limitation code (hospital admittance)
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if they had a therapeutic limitation code upon admittance.
Prevalence of a therapeutic limitation code (hospital discharge)
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if received a therapeutic limitation code upon hospital discharge.
9 secondary outcomes
social status
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
autonomy status
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
cognitive status
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
diagnosis
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
hospitalisation length
Time frame: Patients hopitalized from 01/04/2015 till present date (11 months)
Albumine
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Hydratation level
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Unintentional weigh loss
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
Presence of comorbidities
Time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)
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 18 Jan 2018.
- Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Background: PubMed 6860082Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.
- Background: PubMed 3249773Yesavage JA. Geriatric Depression Scale. Psychopharmacol Bull. 1988;24(4):709-11. No abstract available.
- Background: PubMed 9264935Clement JP, Nassif RF, Leger JM, Marchan F. [Development and contribution to the validation of a brief French version of the Yesavage Geriatric Depression Scale]. Encephale. 1997 Mar-Apr;23(2):91-9. French.
- Background: PubMed 15156548Goring H, Baldwin R, Marriott A, Pratt H, Roberts C. Validation of short screening tests for depression and cognitive impairment in older medically ill inpatients. Int J Geriatr Psychiatry. 2004 May;19(5):465-71. doi: 10.1002/gps.1115.
- Background: PubMed 2240918Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Background: PubMed 6418786Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
- Background: PubMed 9256840Katz PR, Karuza J, Kolassa J, Hutson A. Medical practice with nursing home residents: results from the National Physician Professional Activities Census. J Am Geriatr Soc. 1997 Aug;45(8):911-7. doi: 10.1111/j.1532-5415.1997.tb02958.x.
- Background: PubMed 11352254Katz PP, Yelin EH. Activity loss and the onset of depressive symptoms: do some activities matter more than others? Arthritis Rheum. 2001 May;44(5):1194-202. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-6.
- Background: PubMed 17530671Katz PP, Morris A. Use of accommodations for valued life activities: prevalence and effects on disability scores. Arthritis Rheum. 2007 Jun 15;57(5):730-7. doi: 10.1002/art.22765.
- Background: PubMed 10399508Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French.
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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.
Murielle Surquin, MD principal investigator
CHU Brugmann
Axelle Gregory, MD principal investigator
CHU Brugmann
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 Geriatrics, run by Brugmann University Hospital at 1 site in Belgium.
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: finished, as of the sponsor's last update on 18 Jan 2018. 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 Belgium. 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?
Prevalence of a therapeutic limitation code (hospital admittance) (time frame: Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months)). The study lists 2 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 NCT02682979, which also lists 11 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 18 Jan 2018.