Information and Communication Technologies (ICTS) in Dentistry for SUS
2021年3月12日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
368
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
São Paulo、巴西、05508000
- 招聘中
- University of Sao Paulo
-
接触：
- Mariana Minatel Braga, Phd
- 电话号码：992014818
- 邮箱：mmbraga@usp.br
-
接触：
- Maria Eduarda Franco Viganó, Graduation
- 电话号码：(11)99518-1964
- 邮箱：maria.vigano@usp.br
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 13年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
|
有源比较器：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).
|
No intervention (at least, until the time frame for outcome assessment)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Family/patient´s perception about the dental care
大体时间：2 weeks after intervention (or one week of waiting - in the case of the control group)
|
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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Increment in caries experience since the interruption of dental care
大体时间：1 year after intervention
|
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.
|
1 year after intervention
|
|
Increment or changes in the needs for dental treatment
大体时间：1 year after intervention
|
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.
|
1 year after intervention
|
|
Demand resolution after intervention
大体时间：2 weeks after intervention
|
Interview for checking about the resolution of demands pointed out during the baseline consultation.
|
2 weeks after intervention
|
|
Need for reorientation about oral hygiene
大体时间：2 weeks, 3 months, 6 months, 1 year after intervention
|
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.
|
2 weeks, 3 months, 6 months, 1 year after intervention
|
|
Perception of caregivers regarding primary care and dental care.
大体时间：2 weeks after intervention
|
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.
|
2 weeks after intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mariana M Braga, PhD、USP
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年12月1日
初级完成 (预期的)
2021年6月30日
研究完成 (预期的)
2022年6月30日
研究注册日期
首次提交
2021年3月8日
首先提交符合 QC 标准的
2021年3月12日
首次发布 (实际的)
2021年3月15日
研究记录更新
最后更新发布 (实际的)
2021年3月15日
上次提交的符合 QC 标准的更新
2021年3月12日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.