Information and Communication Technologies (ICTS) in Dentistry for SUS
12. mars 2021 oppdatert av: Mariana Minatel Braga, University of Sao Paulo
Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
At the time of the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care.
In order to minimize the impact of this outage of face-to-face care, information and communication technologies could be an alternative and even likely to be envisioned within the Brazilian Unified Health System (SUS).
In this sense, this study sought to show the impact of the use of information and communication technologies (ICT) in the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic, proposing the use of telemonitoring, teleorientation and telescreening to resolve and address demands arising from this outage in primary elective care.
The impact of the use of these strategies will be measured in terms of problem-solving, reduction of waiting time to resolve complaints and caregivers' perception about received care.
For this, two clinical studies were designed and a primarily trial-based economic evaluation was planned.
Mathematical models will be used to transpose these results into the reality of the SUS, in view of the State Health Secretariat of São Paulo and different Brazilian scenarios.
Finally, the investigators also aim to study the possibility of implementing these technologies mentioned in the daily life of the SUS, even after a pandemic, and to check the possibility of incorporating and costing them, as well as exploring possible social impact and relationship with possible inequities in health.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Project Objectives:
This proposal has as a general objective to show the impact of the use of information and communication technologies (ICT) on the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic.
To this do so, the following specific objectives are defined:
- To identify the pent-up demand for the outage of dental care and the benefits and difficulties, as well as the perception of users, in the implementation of new strategies of non-face-to-face care based on technology (teleservice), using a primary care cell unit for children and prospecting, through models, this situation for the scenario of the Unified Health System (SUS).
- Perform different forms of economic evaluation to measure whether the gains achieved with the implementation of teleservice (telescreening, teleorientation and telemonitoring) compensate for the additional costs possibly associated with it, or whether teleservice modalities are associated with long-term resource savings, taking into account the implementation sized for the Brazilian public health system.
- Explore how the introduction of these technologies could benefit the SUS in the trans and post-pandemic period, contribute to the correction of possible inequities in health care and other social aspects, as well as result in possible differences when different Brazilian scenarios are explored.
Studietype
Intervensjonell
Registrering (Forventet)
368
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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São Paulo, Brasil, 05508000
- Rekruttering
- University of Sao Paulo
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Ta kontakt med:
- Mariana Minatel Braga, Phd
- Telefonnummer: 992014818
- E-post: mmbraga@usp.br
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Ta kontakt med:
- Maria Eduarda Franco Viganó, Graduation
- Telefonnummer: (11)99518-1964
- E-post: maria.vigano@usp.br
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 år til 13 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children from 3 to 13 years old who are involved in clinical studies and who already undergo follow-up from 6 to 60 months in the mobile dental unit.
Exclusion Criteria:
- Guardian´s participants) who do not accept to participate in the research and if participants accept.
- Children who do not assent with participation in the research (when already literate). - For children aged 3 to 6 years, included in the research, the waiver of the need to fill out the term of free and informed assent was requested, considering that these children are not literate and would not be able to write, to assent with the participation. t
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
In the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry.
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Teleservice will be performed through a digital platform (Video for Health" - V4H).
The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus.
A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded.
The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject.
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Aktiv komparator: Waiting list
In the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes.
Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention).
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No intervention (at least, until the time frame for outcome assessment)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Family/patient´s perception about the dental care
Tidsramme: 2 weeks after intervention (or one week of waiting - in the case of the control group)
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Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy. A total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants' perceptions, one item asked, "How do you feel about these service attributes that are already provided?", which was scored on a 5-point Likert-type scale of "very bad (1)" to "very good (5)." |
2 weeks after intervention (or one week of waiting - in the case of the control group)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Increment in caries experience since the interruption of dental care
Tidsramme: 1 year after intervention
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Clinical examination focused using dmft and DMFT indices and comparison to those.
An previously recorded in participant´s records, resulting in the difference between the indices between these moments (DMFT+dmft final - DMFT+dmft when treatment was interrupted).
An examiner unaware of baseline conditions will assess these indices.
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1 year after intervention
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Increment or changes in the needs for dental treatment
Tidsramme: 1 year after intervention
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Clinical examination focused in detecting if there is need for dental treatment or not (including untreated caries, need for restoration repair, need of gingival or periodontal treatment, need for extractions for any reason).
An examiner unware of baseline conditions will assess such needs.
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1 year after intervention
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Demand resolution after intervention
Tidsramme: 2 weeks after intervention
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Interview for checking about the resolution of demands pointed out during the baseline consultation.
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2 weeks after intervention
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Need for reorientation about oral hygiene
Tidsramme: 2 weeks, 3 months, 6 months, 1 year after intervention
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Interview for checking doubts about oral hygiene and checklist of items to be accomplished during oral hygiene demonstrated by child.
An external examiner will evaluate all listed items.
In case of any one is not checked, the need of reorientation is considered.
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2 weeks, 3 months, 6 months, 1 year after intervention
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Perception of caregivers regarding primary care and dental care.
Tidsramme: 2 weeks after intervention
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Semi-structured interviews, applied with guided questions to try to assess participants' and parents' perception, as well as potential barriers and facilitators associated with dental care during the pandemic period with the caregivers of the children who followed the teleservice.
For this, individual interviews will be recorded and transcribed.
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2 weeks after intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mariana M Braga, PhD, USP
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2020
Primær fullføring (Forventet)
30. juni 2021
Studiet fullført (Forventet)
30. juni 2022
Datoer for studieregistrering
Først innsendt
8. mars 2021
Først innsendt som oppfylte QC-kriteriene
12. mars 2021
Først lagt ut (Faktiske)
15. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TeleDent-COVID19
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .