Clinical trial NCT04798599: Information and Communication Technologies (ICTS) in Dentistry for SUS
Official title: Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Dental Diseases
Keywords: Child
COVID-19
Information Technology
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of Paraíba
name: Federal University of São Paulo
First posted: 2021-03-15
Enrollment: 368
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This protocol refers to a randomized, patient-controlled study on a waiting list, nested to a before-after type study to be conducted in a cell unit, simulating a basic dental health unit. Next, a modelling study was idealized, prospecting the situation found for the reality and integral demand of the Unified Health System.

The "before-after" study was designed to measure the positive and negative effects resulting from telecare implementation in primary care for children. The randomised controlled study evaluates the impact of teleservice implementation from the patient´s and parents perception and allows comparison with a reference. For that, children potentially eligible for the study will initially be randomized to one group (intervention vs waiting list). On the waiting list, participants will receive the intervention (standardized telecare) and will be evaluated for outcomes of interest two weeks later.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

1. 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).
2. 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.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Family/patient´s perception about the dental care
timeFrame: 2 weeks after intervention (or one week of waiting - in the case of the control group)
Secondary outcomes:
measure: Increment in caries experience since the interruption of dental care
timeFrame: 1 year after intervention
measure: Increment or changes in the needs for dental treatment
timeFrame: 1 year after intervention
measure: Demand resolution after intervention
timeFrame: 2 weeks after intervention
measure: Need for reorientation about oral hygiene
timeFrame: 2 weeks, 3 months, 6 months, 1 year after intervention
measure: Perception of caregivers regarding primary care and dental care.
timeFrame: 2 weeks after intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: USP
name: Mariana M Braga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natal KH, Machado TG, Bracco F, Lemos LI, Vigano ME, Machado GM, Yampa-Vargas JD, Raggio DP, Mendes FM, Imparato JCP, Lucena EHG, Cavalcanti YW, Silva CI, Souza Filho GL, Macedo MCS, Carrer FCA, Braga MM. Using information and communication technologies (ICTs) to solve the repressed demand for primary dental care in the Brazilian Unified Health System due to the COVID-19 pandemic: a randomized controlled study protocol nested with a before-and-after study including economic analysis. BMC Oral Health. 2022 Apr 7;22(1):112. doi: 10.1186/s12903-022-02101-9.