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Health Services for the AgedEFFORTNCT03486977

Effectiveness and Organizational Conditions of Effectiveness of Telemedicine in Establishments Providing Care for the Dependent Elderly

An observational study of Health Services for the Aged, run by University Hospital, Bordeaux at 24 sites 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

Study of interest of Telemedicine in establishments providing care for the dependent elderly (EHPAD in french) is a strategy for improving the course of care of residents, including the number not programmed hospitalizations, and a multidimensional analysis of the conditions of effectiveness of telemedicine will… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Health Services for the Aged
What is being tested?
Evaluation of disease and follow-up
Type of treatment
Surgery or procedure
How many people
373 participants
Where
24 sitesFrance
Study dates
1 Nov 2017to 12 Jul 2019
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: All residents of EHPAD, men and women 65 years of age and more and likely to be eligible for a teleconsultation as suffering from one of the identified chronic pathologies as a reason for teleconsultation by Regional Agency of Hearth, will be included in the study in two groups of long-term care facilities. Eligible residents will be included in a very short time of 3 months.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • EHPAD Le home medocain Arsac

    Arsac, 33460

  • EHPAD Le parc du Bequet

    Bègles, 33130

  • EHPAD Manon Cormier

    Bègles, 33130

  • EHPAD Henry Dunant

    Bordeaux, 33000

  • EHPAD Le Clos Serena

    Bordeaux, 33000

  • EHPAD Résidence les Carmes

    Bordeaux, 33000

  • EHPAD Cos villa Pia

    Bordeaux, 33082

  • EHPAD Grand Bon Pasteur

    Bordeaux, 33200

  • EHPAD Residence Aime Cesaire

    Bordeaux, 33200

  • EHPAD Le Platane du Grand Parc

    Bordeaux, 33300

  • EHPAD Seguin

    Cestas, 33610

  • EHPAD résidence du Tertre

    Fronsac, 33126

  • EHPAD Douceur de France

    Gradignan, 33170

  • EHPAD Résidence l'Arousiney

    Gujan-Mestras, 33470

  • EHPAD Le rétou

    Lamarque, 33460

  • EHPAD Les coteaux

    Lormont, 33310

  • Résidence de Médicis

    Mérignac, 33700

  • EHPAD CHU Bordeaux

    Pessac, Lormont, 33600

  • EHPAD Fontaudin

    Pessac, 33600

  • EHPAD Villa presentine

    Rauzan, 33420

  • EHPAD Jacqueline Auriol

    Saint-Seurin-sur-l'Isle, 33660

  • EHPAD Résidence La berge du lac

    Talence, 33110

  • EHPAD Villa Bontemps

    Talence, 33400

  • EHPAD Home Marie Curie

    Villenave-d'Ornon, 33140

Other trials in France

About this study

Study of interest of Telemedicine in establishments providing care for the dependent elderly (EHPAD in french) is a strategy for improving the course of care of residents, including the number not programmed hospitalizations, and a multidimensional analysis of the conditions of effectiveness of telemedicine will identify the keys to optimize its use.

Read the 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.

Being tested
Evaluation of disease and follow-up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of disease and follow-upProcedure or surgery

    Also called Telemedicine

    Correspondence medical consultation with specific device

Study groups in NCT03486977
Study groupRoleWhat they receive
Establishments with telemedicine systemEstablishments equipped for telemedicine (teleconsultation, casualty) as part of the regional project of the Aquitaine regional program telemedicine device deployment.
Receives: Procedure: Evaluation of disease and follow-up
Establishments without telemedicine systemDefined 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
Receives: Procedure: Evaluation of disease and follow-up

What is being measured

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

  1. Number of hospitalization not programmed residents on Medicine Surgery obstetrics (MCO)

    Number of hospitalizations not programmed residents on Medicine Surgery obstetrics (MCO) between the inclusion and 12 month

    Measured: 12 months

Secondary outcomes (2)

  1. the main diagnosis, coded by the International Classification of diseases for every hospitalization

    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).

    Measured: 12 months

  2. Score of the specific questionnaire for measurement of the context organizational and Managerial in health care facilities

    Evaluate the impact of a strategy issued in EHPAD type teleconsultation or casualty on the quality of work life

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2018
  2. Study start1 Nov 2017
  3. Primary completion12 Jul 2019
  4. Study completion12 Jul 2019

Resources

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
Cohort
Time perspective
Prospective
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03486977
Sponsor's protocol ID
CHUBX 2016/32
Acronym
EFFORT
Status last verified
Jan 2020
First submitted
23 Jan 2018
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19484845

  • 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.

    PubMed 19807810

  • 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.

    PubMed 26485153

  • 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.

    PubMed 24456561

  • 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.

    PubMed 33598307

Questions about this trial

What is this clinical trial studying?

An observational study of Health Services for the Aged, run by University Hospital, Bordeaux at 24 sites 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 7 inclusion and 2 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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?

Number of hospitalization not programmed residents on Medicine Surgery obstetrics (MCO) (time frame: 12 months). 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 NCT03486977, which also lists 5 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 7 Jan 2020.

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