Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

Not Applicable

Terminated

• Conditions: Tooth Diseases

• Registration Number: NCT03871569
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-10-10
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care	At month 6	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).

Secondary Outcome Measures

Name	Time	Method
Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care	At month 6	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"
Quality of life comparison: EQ5D-3L questionnaire	At month 6	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.
Economic impact of teleexpertise on dental treatment	At month 6	Budgetary impact of the new coverage expressed in annual cash flows
Evaluate satisfaction rate of use of teleexpertise of nursing home staff	At month 6	Satisfaction of nursing home staff measured by an ad hoc Likert scale
Compare the emergency score	At month 0 and at month 6	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".

Trial Locations

Locations (13)

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

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