Cognitive ImpairmentPAGENCT02749669
Health Care Courses of Elderly Hospitalized Patients for Inappropriate Reasons: Qualitative and Economic Analyzes
A study testing Qualitative research in people with Cognitive Impairment, run by Régis AUBRY at 1 site in France.
Trial summary
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Qualitative research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Feb 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients 75 years old and older,
- Hospitalized in the emergency or geriatric units of the University Hospital of Besançon for inappropriate reasons according to Appropriate Assessment Protocol criteria,
- With a history of mild to moderate cognitive impairment according to the latest cognitive assessment (HAS 2009),
- Who have expressed no objection towards collecting and processing personal data (health care, health status, demographic and socio-economic characteristics) after information regarding the goals and course of the study.
- Adults under guardianship may be included
- For the five patients followed:
- Able to speak French,
- Who have given their written consent to participate in the study after information about the objectives and course of the study (interviews, collection of personal data).
Who cannot join
- Patients who have expressed their opposition to collecting and processing personal data.
- For the five patients followed:
- Patients with a history of cognitive impairment preventing the semi-structured interview,
- Unable to speak French.
Trial locations and contacts
1 site in 1 country.
About this study
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Those are inappropriate because the patient could have a paramedical and social care at home or in more efficient structures. The hospital remains the place of remedy for social and health situations whose resolution was not possible because of a lack of infrastructure available, of patient or his relative information, or a lack of coordination in medico-social establishment.
These inappropriate hospitalizations involve an increase of length of stay that enhancing the fragility and vulnerability of the elderly. They have deleterious effects as decompensation, comorbidities and loss of autonomy.
Read more
Moreover, the suffering of natural or informal caregivers is also an important public health question; Caregivers may have a serious disease resulting from caring their relative. That leads to increase their consumption of health care and medical goods.
This comprehensive study will highlight the deficiencies of the actual health care through the analysis of the speech of the different parts involved (main study). Simultaneously, a comparative analysis of the costs of health care will be conducted (economic combined study).
Read the detailed description
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Those are inappropriate because the patient could have a paramedical and social care at home or in more efficient structures. The hospital remains the place of remedy for social and health situations whose resolution was not possible because of a lack of infrastructure available, of patient or his relative information, or a lack of coordination in medico-social establishment.
These inappropriate hospitalizations involve an increase of length of stay that enhancing the fragility and vulnerability of the elderly. They have deleterious effects as decompensation, comorbidities and loss of autonomy.
Moreover, the suffering of natural or informal caregivers is also an important public health question; Caregivers may have a serious disease resulting from caring their relative. That leads to increase their consumption of health care and medical goods.
This comprehensive study will highlight the deficiencies of the actual health care through the analysis of the speech of the different parts involved (main study). Simultaneously, a comparative analysis of the costs of health care will be conducted (economic combined study).
When a patient over 75 years will arrive in the emergency or geriatrics units of the University Hospital of Besançon and the reason for admission indicated in the hospital record will be " difficult home care " or " caregiver burn out " or any other reason unjustified from a strictly medical point of view, the investigator will ensure the patient's eligibility under the inclusion and non-inclusion criteria, and will do a review of appropriateness of hospital according Appropriate Assessment Protocol criteria.
All patients corresponding to the inclusion criteria during the three months of the inclusion period will be identified in the reference population. Expected active file is fifteen patients in three months. The reference population of patients in the active file will be followed for six months. Steps of their health care will be identified and described in a questionnaire detailing the patient's pathway by collecting data on:
- Dates when they change their place of living or care,
- Places of living or care at every step.
The qualitative study will include five patients of the reference population in order to describe, analyze and understand in depth their health care through semi-structured interviews. To analyze a variety of pathways, 5 patients will be selected in order to represent the heterogeneity of admission places (emergency or geriatric unit), as well as the places of origin (home institution).
The interview will be also proposed to relevant people involved (health professionals, professional home) in the situation and at least to one relative designated by the patient.
For each change of place of residence or place of care (or return at home) of the five patients, the interviews will be conducted with the patient and relevant stakeholders.
At the end of the first step, the investigator will join to the outgoing mail, a document to ensure that the later steps of patient health care is collected. For each step, the referring health professional will have to do the same in order to compile data of the patient's pathway.
Thus, from an estimate of three key steps to describe and analyze the healthcare trajectories of five patients during six months, 90 interviews will be conducted, transcribed and analyzed.
The economic combined study will focus on the five patients followed in the qualitative study. This descriptive and prospective study will analyze the differential costs between the actual health care course and a more appropriate care course. The study will be conducted according to a "societal" perspective.
The most appropriate health care courses will be selected by healthcare professionals who specialize in elderly care in the Besançon area (medical structures, gerontological network…). The patients actual care courses will be presented to them and they will collectively decide which care course would have been most appropriate for each patient.
The costs of the actual and most appropriate courses will be evaluated as follows:
- Direct medical costs regarding hospitalizations, consultations, medical and technical procedures, laboratory and pathology costs, and medical transport expenses.
- Direct non-medical costs regarding social expenses (accommodation). Welfare received by the elderly patients; expenses of the elderly patients or their relatives related to special facilities and adaptation of the home. Allowances received by relatives in case of sick leave and the cost associated with consumption of medication and medical transport (sleep disorders, anxiety and depression, nutritional and memory disorders, cardiovascular disorders including hypertension, decompensation of chronic diseases...).
These costs will be collected:
- in the patient's medical record,
- in the record compiled by the social worker,
- in the databases of Regional Health Authority of Franche-Comté
- in the hospital Discharge Abstract Database (PMSI)
- as well as with a questionnaire to patients and caregivers.
The global expenditure related to the actual care course and the most appropriate course as defined by healthcare professionals will be calculated.
Finally, this economic combined study will analyze the differential costs between current patient health care and a more relevant patient health care.
- Conditions
- Cognitive Impairment
- Being tested
- Qualitative research
- Keywords
- Inappropriate hospitalization, elderly, mild or moderate cognitive impairment, qualitative research, economic evaluation
- Medical subject headings
- Cognitive Dysfunction, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative researchOther
Semi-structured Interviews
| Study group | Role | What they receive |
|---|---|---|
| Qualitative research | Other | Semi-structured interviews Receives: Other: Qualitative research |
| Economic evaluation | No intervention | Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 semi-structured interviews
Qualitative Data analysis - Theoretical saturation
Measured: 6 months
Secondary outcomes (2)
Demographic and socio-economic questionnaires of 15 patients
Socio-economic analysis
Measured: 6 months
Caregiver Reaction Assessment (CRA) scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Régis AUBRY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Régis AUBRY, Centre Hospitalier Universitaire de Besancon
- Investigators
- Séverine KOEBERLE, Dr, Principal investigator, Centre Hospitalier Universitaire de BesanconThomas TANNOU, Dr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749669
- Sponsor's protocol ID
- PAGE
- Acronym
- PAGE
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Courses of Elderly Hospitalized Patients for Inappropriate Reasons: Qualitative and Economic Analyzes
- ClinicalTrials.gov ID
- NCT02749669
- Acronym / sponsor ID
- PAGE / PAGE
- Conditions
- Cognitive Impairment
- Keywords
- Inappropriate hospitalization, elderly, mild or moderate cognitive impairment, qualitative research, economic evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Régis AUBRYUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Apr 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.
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Those are inappropriate because the patient could have a paramedical and social care at home or in more efficient structures. The hospital remains the place of remedy for social and health situations whose resolution was not possible because of a lack of infrastructure available, of patient or his relative information, or a lack of coordination in medico-social establishment.
These inappropriate hospitalizations involve an increase of length of stay that enhancing the fragility and vulnerability of the elderly. They have deleterious effects as decompensation, comorbidities and loss of autonomy.
Moreover, the suffering of natural or informal caregivers is also an important public health question; Caregivers may have a serious disease resulting from caring their relative. That leads to increase their consumption of health care and medical goods.
This comprehensive study will highlight the deficiencies of the actual health care through the analysis of the speech of the different parts involved (main study). Simultaneously, a comparative analysis of the costs of health care will be conducted (economic combined study).
Detailed description
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Those are inappropriate because the patient could have a paramedical and social care at home or in more efficient structures. The hospital remains the place of remedy for social and health situations whose resolution was not possible because of a lack of infrastructure available, of patient or his relative information, or a lack of coordination in medico-social establishment.
These inappropriate hospitalizations involve an increase of length of stay that enhancing the fragility and vulnerability of the elderly. They have deleterious effects as decompensation, comorbidities and loss of autonomy.
Moreover, the suffering of natural or informal caregivers is also an important public health question; Caregivers may have a serious disease resulting from caring their relative. That leads to increase their consumption of health care and medical goods.
This comprehensive study will highlight the deficiencies of the actual health care through the analysis of the speech of the different parts involved (main study). Simultaneously, a comparative analysis of the costs of health care will be conducted (economic combined study).
When a patient over 75 years will arrive in the emergency or geriatrics units of the University Hospital of Besançon and the reason for admission indicated in the hospital record will be " difficult home care " or " caregiver burn out " or any other reason unjustified from a strictly medical point of view, the investigator will ensure the patient's eligibility under the inclusion and non-inclusion criteria, and will do a review of appropriateness of hospital according Appropriate Assessment Protocol criteria.
All patients corresponding to the inclusion criteria during the three months of the inclusion period will be identified in the reference population. Expected active file is fifteen patients in three months. The reference population of patients in the active file will be followed for six months. Steps of their health care will be identified and described in a questionnaire detailing the patient's pathway by collecting data on:
- Dates when they change their place of living or care,
- Places of living or care at every step.
The qualitative study will include five patients of the reference population in order to describe, analyze and understand in depth their health care through semi-structured interviews. To analyze a variety of pathways, 5 patients will be selected in order to represent the heterogeneity of admission places (emergency or geriatric unit), as well as the places of origin (home institution).
The interview will be also proposed to relevant people involved (health professionals, professional home) in the situation and at least to one relative designated by the patient.
For each change of place of residence or place of care (or return at home) of the five patients, the interviews will be conducted with the patient and relevant stakeholders.
At the end of the first step, the investigator will join to the outgoing mail, a document to ensure that the later steps of patient health care is collected. For each step, the referring health professional will have to do the same in order to compile data of the patient's pathway.
Thus, from an estimate of three key steps to describe and analyze the healthcare trajectories of five patients during six months, 90 interviews will be conducted, transcribed and analyzed.
The economic combined study will focus on the five patients followed in the qualitative study. This descriptive and prospective study will analyze the differential costs between the actual health care course and a more appropriate care course. The study will be conducted according to a "societal" perspective.
The most appropriate health care courses will be selected by healthcare professionals who specialize in elderly care in the Besançon area (medical structures, gerontological network…). The patients actual care courses will be presented to them and they will collectively decide which care course would have been most appropriate for each patient.
The costs of the actual and most appropriate courses will be evaluated as follows:
- Direct medical costs regarding hospitalizations, consultations, medical and technical procedures, laboratory and pathology costs, and medical transport expenses.
- Direct non-medical costs regarding social expenses (accommodation). Welfare received by the elderly patients; expenses of the elderly patients or their relatives related to special facilities and adaptation of the home. Allowances received by relatives in case of sick leave and the cost associated with consumption of medication and medical transport (sleep disorders, anxiety and depression, nutritional and memory disorders, cardiovascular disorders including hypertension, decompensation of chronic diseases...).
These costs will be collected:
- in the patient's medical record,
- in the record compiled by the social worker,
- in the databases of Regional Health Authority of Franche-Comté
- in the hospital Discharge Abstract Database (PMSI)
- as well as with a questionnaire to patients and caregivers.
The global expenditure related to the actual care course and the most appropriate course as defined by healthcare professionals will be calculated.
Finally, this economic combined study will analyze the differential costs between current patient health care and a more relevant patient health care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative research | Other | Other: Qualitative researchSemi-structured interviews |
| Economic evaluation | No intervention | –Questionnaire |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients 75 years old and older,
- Hospitalized in the emergency or geriatric units of the University Hospital of Besançon for inappropriate reasons according to Appropriate Assessment Protocol criteria,
- With a history of mild to moderate cognitive impairment according to the latest cognitive assessment (HAS 2009),
- Who have expressed no objection towards collecting and processing personal data (health care, health status, demographic and socio-economic characteristics) after information regarding the goals and course of the study.
- Adults under guardianship may be included
Key exclusion criteria (4 listed)
- Patients who have expressed their opposition to collecting and processing personal data.
- Patients with a history of cognitive impairment preventing the semi-structured interview,
- Unable to speak French.
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 researchSemi-structured Interviews | Other | Qualitative research |
Primary outcome
90 semi-structured interviews
Time frame: 6 months
Qualitative Data analysis - Theoretical saturation
2 secondary outcomes
Demographic and socio-economic questionnaires of 15 patients
Time frame: 6 months
Caregiver Reaction Assessment (CRA) scale
Time frame: 6 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 1 Feb 2017.
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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.
Séverine KOEBERLE, Dr principal investigator
Centre Hospitalier Universitaire de Besancon
Thomas TANNOU, Dr principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative research in people with Cognitive Impairment, run by Régis AUBRY 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 8 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: finished, as of the sponsor's last update on 1 Feb 2017. 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?
90 semi-structured interviews (time frame: 6 months). 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 1 Feb 2017.