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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.

Completed

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

Official record
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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.

France1 site
  • AUBRY Regis

    Besançon, 25000

Other trials in France

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.

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 groups in NCT02749669
Study groupRoleWhat they receive
Qualitative researchOtherSemi-structured interviews
Receives: Other: Qualitative research
Economic evaluationNo interventionQuestionnaire

What is being measured

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

  1. 90 semi-structured interviews

    Qualitative Data analysis - Theoretical saturation

    Measured: 6 months

Secondary outcomes (2)
  1. Demographic and socio-economic questionnaires of 15 patients

    Socio-economic analysis

    Measured: 6 months

  2. 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.

  1. First posted25 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionAug 2016
  4. Study completionFeb 2017

Resources

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)
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

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.

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