Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

Tooth Diseases Clinical Trial

— e-DENT-EHPAD  

Official title:

Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03871569
• Other study ID #: RECHMPL18_0079
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.

The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.

The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 171
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

Inclusion Criteria:

• Be resident of a facility for dependent elderly persons involved in the study

• Have given their Free, informed and signed consent

• Beneficiary or member of a social security scheme

Exclusion Criteria:

• incapacity to open the mouth

• contrary opinion of the medical team (end of life)

• Change of nursing home planned within 6 months

• Subject in a period of relative exclusion from another protocol

• Subject's participation in another study

• Subject deprived of liberty by judicial or administrative decision

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Other:
• bucco-dental teleexpertise
A bucco-dental consultation remotely using telemedicine system

Locations

Country	Name	City	State
France	EHPAD Le Sherpa	Belmont sur Rance
France	EHPAD Via Domitia	Castelnau-le-Lez
France	EHPAD Korian La Colombe	Gigean
France	EHPAD Korian Perier	Marseille
France	EHPAD La Roselière	Marsillargues
France	EHPAD Françoise Gauffier	Montpellier
France	EHPAD Korian La Pompignane	Montpellier
France	EHPAD La Carriera	Montpellier
France	EHPAD Montpellieret	Montpellier
France	EHPAD Pierre Laroque	Montpellier
France	Résidence mutualiste de Pezilla	Pezilla la rivière
France	EHPAD Saint Jean	Saint-Amans-des-Cots
France	EHPAD Saint Jean Pla de Corts	St Jean Pla de Corts

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care	Costs include telemedicine and medical costs related to oral health care. Utility correspond to the Quality Adjusted Life-Years (QALY) score measured using the EQ5D-3L questionnaire (EuroQol 3 levels of 5 dimensions).	At month 6
Secondary	Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care	Costs include telemedicine and medical costs related to oral health care.; The clinical efficacy criteria correspond to the proportion of patients with a zero dental emergency score. The score of Emergency is measured according to WHO classification: Score "0" correspond to "unnecessary care"; Score "1" correspond to "descaling required"; Score "2" correspond to "Low urgency: need for restoration and/or crown but not immediately (superficial damage to the tooth). Includes patients requiring fixed and/or removable prostheses".; Score "3" correspond to: "Advanced emergency: need for restorations and/or crowns quickly (within 7 to 14 days) to avoid pulp damage and/or infection"; Score "4" correspond to: "High urgency: urgent need for care due to pain and/or infection. Includes patients requiring endodontic treatment or extraction"	At month 6
Secondary	Quality of life comparison: EQ5D-3L questionnaire	The Quality of Life measured using the EQ5D-3L (EuroQol 3 levels of 5 dimensions) questionnaire. EQ-5D-3L questionnaire comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Levels of perceived problems are coded as follows: Level 1 (no problems) is coded as a '1' - Level 2 (some problems) is coded as a '2' - Level 3 (extreme problems) is coded as a '3'. The best score for the 5 dimensions is coded by '11111' and the worst state is coded by '33333'. In addition a EQ visual analogue scale (EQ VAS) help people say how good or bad a health state is, on which the best state is marked 100 and the worst state is marked 0.	At month 6
Secondary	Economic impact of teleexpertise on dental treatment	Budgetary impact of the new coverage expressed in annual cash flows	At month 6
Secondary	Evaluate satisfaction rate of use of teleexpertise of nursing home staff	Satisfaction of nursing home staff measured by an ad hoc Likert scale	At month 6
Secondary	Compare the emergency score	The emergency score measured by the Oral Health Assessment Tool (OHAT) questionnaire. The OHAT comprises eight categories of screening tool to assess oral health : Lips, Tongue, Gums and tissues, Saliva, Natural teeth, Dentures, Oral cleanliness, Dental pain. After a dental examination by telemedicine, the dentist will evaluate each category as following : Score "0" correspond to "healthy", score "1" corresponds to "changes" or score "3" correspond to "unhealthy".	At month 0 and at month 6