- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03486977
Effectiveness and Organizational Conditions of Effectiveness of Telemedicine in Establishments Providing Care for the Dependent Elderly (EFFORT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The project combines quantitative and qualitative analyses :
1. Quantitative study
Study of comparative prospective cohort clustered in two parallel groups:
Group 'Telemedicine': establishments providing care for the dependent elderly (EHPAD in french) equipped for telemedicine (teleconsultation, casualty) as part of the regional project of the Aquitaine Regional Agency of Heath telemedicine device deployment.
Control group: Defined and equipped for telemedicine EHPAD after matching on the number of residents, the GMP (average weighted GIR : "Groupes Iso Ressources" = score to reflects the average level of dependency of residents of a residential care facility for the elderly), the PMP (weighted average PATHOS = an evaluation system set up by the National Union of Clinical Gerontology and the Medical Service of the National Fund for Health Insurance for Salaried Workers), the distance to a hospital with an emergency shelter service.
The rate of unscheduled hospitalizations will be collected during follow-up visits in clinical departments of the healthcare of the Gironde (french department) by a research staff.
2 Qualitative study In the Group of nursing homes with telemedicine, said group "Telemedicine", will be identified four long-term care facilities, selected according to their degree of use of telemedicine (ratio number of teleconsultation per month / number of beds) (EHPAD 2 strong users, 2 nursing homes) low users) within these four long-term care facilities will be carried out observations of field and in-depth interviews with professionals, managers and attending physicians.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Arsac, France, 33460
- EHPAD Le home medocain Arsac
-
Bordeaux, France, 33000
- EHPAD Henry Dunant
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Bordeaux, France, 33000
- EHPAD Le Clos Serena
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Bordeaux, France, 33000
- EHPAD Résidence les Carmes
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Bordeaux, France, 33082
- EHPAD Cos villa Pia
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Bordeaux, France, 33200
- EHPAD Grand Bon Pasteur
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Bordeaux, France, 33200
- EHPAD Residence Aime Cesaire
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Bordeaux, France, 33300
- EHPAD Le Platane du Grand Parc
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Bègles, France, 33130
- EHPAD Le parc du Bequet
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Bègles, France, 33130
- EHPAD Manon Cormier
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Cestas, France, 33610
- EHPAD Seguin
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Fronsac, France, 33126
- EHPAD résidence du Tertre
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Gradignan, France, 33170
- EHPAD Douceur de France
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Gujan-Mestras, France, 33470
- EHPAD Résidence l'Arousiney
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Lamarque, France, 33460
- EHPAD Le rétou
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Lormont, France, 33310
- EHPAD Les coteaux
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Mérignac, France, 33700
- Résidence de Médicis
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Pessac, France, 33600
- EHPAD Fontaudin
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Rauzan, France, 33420
- EHPAD Villa presentine
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Saint Seurin sur l'Isle, France, 33660
- EHPAD Jacqueline Auriol
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Talence, France, 33110
- EHPAD Résidence La berge du lac
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Talence, France, 33400
- EHPAD Villa Bontemps
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Villenave-d'Ornon, France, 33140
- EHPAD Home Marie Curie
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Lormont
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Pessac, Lormont, France, 33600
- EHPAD CHU Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Quantitative research:
- All residents of nursing home men and women 65 years of age and more and likely to be eligible for a teleconsultation or a casualty because achieved one of the identified chronic pathologies as a reason for teleconsultation, will be included in both groups of long-term care
- Medical professionals working in the nursing home agreeing to answer the specifics questionnaires
Qualitative study:
- Doctors, physicians and coordinators nurses of Establishments Providing Care for the Dependent Elderly, nurses, orderly, psychologists, directors of Establishments
- Having a professional activity in nursing homes selected
- Having given their consent to participate in the study
Exclusion Criteria:
- Residents of long-term care facilities (quantitative study) Resident (or guardian/person) who expressed his opposition to participate in the study or not likely to be eligible for a teleconsultation or casualty Establishments Providing Care for the Dependent Elderly (qualitative) professionals
- Professional who expressed his opposition to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Establishments with telemedicine system
Establishments equipped for telemedicine (teleconsultation, casualty) as part of the regional project of the Aquitaine regional program telemedicine device deployment.
|
Correspondence medical consultation with specific device
Other Names:
|
Establishments without telemedicine system
Defined and equipped for telemedicine EHPAD after mating on the number of residents, the GMP (average weighted GIR), the PMP (weighted average PATHOS), the distance to a hospital with an emergency shelter service. The rate of unscheduled hospitalizations will be collected during follow-up visits in clinical departments of the healthcare of the Gironde by a research staff |
Correspondence medical consultation with specific device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hospitalization not programmed residents on Medicine Surgery obstetrics (MCO)
Time Frame: 12 months
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Number of hospitalizations not programmed residents on Medicine Surgery obstetrics (MCO) between the inclusion and 12 month
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the main diagnosis, coded by the International Classification of diseases for every hospitalization
Time Frame: 12 months
|
Evaluate the number of inappropriate hospitalization.
The inappropriate hospitalization will be performed using the classification of Weissman.
Weissman classification identifies causes of potentially preventable hospitalizations, from the main diagnosis, coded by the International Classification of diseases, version 10 (ICD10).
|
12 months
|
Score of the specific questionnaire for measurement of the context organizational and Managerial in health care facilities
Time Frame: 12 months
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Evaluate the impact of a strategy issued in EHPAD type teleconsultation or casualty on the quality of work life
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie SALLES, MD, PhD, University Hospital, Bordeaux
- Study Chair: Florence SALLIOUR, PhD, University Hospital, Bordeaux
Publications and helpful links
General Publications
- Han JH, Morandi A, Ely EW, Callison C, Zhou C, Storrow AB, Dittus RS, Habermann R, Schnelle J. Delirium in the nursing home patients seen in the emergency department. J Am Geriatr Soc. 2009 May;57(5):889-94. doi: 10.1111/j.1532-5415.2009.02219.x.
- Morandi A, Han JH, Callison C, Ely EW, Schnelle JF. Delirium in nursing home residents across care transitions: a preliminary report. J Am Geriatr Soc. 2009 Oct;57(10):1956-8. doi: 10.1111/j.1532-5415.2009.02472.x. No abstract available.
- Vellas B. Integrating Frailty into Clinical Practice to Prevent the Risk of Dependency in the Elderly. Nestle Nutr Inst Workshop Ser. 2015;83:99-104. doi: 10.1159/000382092. Epub 2015 Oct 20.
- Graverholt B, Forsetlund L, Jamtvedt G. Reducing hospital admissions from nursing homes: a systematic review. BMC Health Serv Res. 2014 Jan 24;14:36. doi: 10.1186/1472-6963-14-36.
- Salles N, Saillour-Glenisson F, Sibe M, Langlois E, Kret M, Durrieu J, Arditi N, Abraham M, Perry F. Effectiveness and organizational conditions of effectiveness of telemedicine in nursing homes. A study protocol of a comparative prospective cohort (EFFORT study). Digit Health. 2021 Jan 24;7:2055207620982422. doi: 10.1177/2055207620982422. eCollection 2021 Jan-Dec.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHUBX 2016/32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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