Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02749669
Other study ID # PAGE
Secondary ID
Status Completed
Phase N/A
First received April 7, 2016
Last updated January 31, 2017
Start date March 2016
Est. completion date February 2017

Study information

Verified date April 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date February 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative research
Semi-structured Interviews

Locations

Country Name City State
France AUBRY Regis Besançon

Sponsors (1)

Lead Sponsor Collaborator
Régis AUBRY

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 90 semi-structured interviews Qualitative Data analysis - Theoretical saturation 6 months
Secondary Demographic and socio-economic questionnaires of 15 patients Socio-economic analysis 6 months
Secondary Caregiver Reaction Assessment (CRA) scale 6 months
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Terminated NCT04493957 - Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Completed NCT04713384 - Remote Bimanual Virtual Rehabilitation Post CVD N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Completed NCT03698695 - A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers Phase 1
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Completed NCT03187353 - IMProving Executive Function Study Phase 4
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A
Recruiting NCT04907565 - Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A