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临床试验/NCT04798599
NCT04798599Unknown不适用

Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
368
试验地点
2
主要终点
Family/patient´s perception about the dental care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

One researcher, who will not participate in teleconsultations (intervention), will be responsible for the questionnaires before the intervention and will randomize the patients. This same researcher will distribute the patients randomly among the dentists responsible for teleconsultations. Dentists will also be blind as to the allocation of the patient to the groups. Also, to the patients/families, it will be not mentioned which group participants are part of. An external operator will be responsible for collecting information about the outcome (questionnaire after the interventions) will also not know which group the patient was allocated. As only the researcher responsible for randomization will know which group the patient belongs to and coordinate all operational parts of the teleconsultations, investigators can ensure the other operators and participants' blinding.

入排标准

年龄范围
3 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Family/patient´s perception about the dental care

时间窗: 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)."

次要结局

  • Increment in caries experience since the interruption of dental care(1 year after intervention)
  • Increment or changes in the needs for dental treatment(1 year after intervention)
  • Need for reorientation about oral hygiene(2 weeks, 3 months, 6 months, 1 year after intervention)
  • Perception of caregivers regarding primary care and dental care.(2 weeks after intervention)
  • Demand resolution after intervention(2 weeks after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Minatel Braga

Principal Investigator

University of Sao Paulo

研究点 (2)

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