Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- incremental cost-effectiveness ratio (ICER)
研究概览
简要总结
The goal of this randomized clinical trial is to assess the cost-effectiveness of a home polyssomnography made by primary care compared to standard protocol for diagnosing obstructive sleep apnea in both genders. Researchers will compare if a polyssomnography made by primary care is more cost-effective than standard protocol to see if this strategy decrease the wait time to get this exam in public health system in Brazil .
Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk, they will be randomized into two groups: one group will undergo the examination via the health department's scheduling system, while the other will do so through primary health care services at the unit closest to their residence.
详细描述
Direct and indirect costs will be estimated for both arms, and the waiting time for patients to receive a diagnosis will be recorded, and the incremental cost-effectiveness ratio (ICER) will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or older;
- •present clinical suspicion of OSA, confirmed by screening using the STOP-BANG and Epworth Sleepiness Scale questionnaires;
- •be receiving care at Basic Health Units (UBS), or be registered on the Central Regulation waiting list system for polysomnography (PSG);
排除标准
- •use of home oxygen therapy;
- •use of invasive or non-invasive mechanical ventilation;
- •use of a tracheostomy;
- •change of residence during the data collection period;
- •known allergy to materials used in sleep monitoring equipment.
结局指标
主要结局
incremental cost-effectiveness ratio (ICER)
时间窗: baseline from 6 months
The ICER will be calculated by: Costs of primary care - Cost of the standard intervention)/(Effect of primary care - Effect of the standard intervention, where the effect be assessed by the time to the patients get the full diagnosis.
次要结局
- Satisfaction level(6 months)
- Apnea-hypopnea Index (AHI)(6 months)
- Time to full diagnosis(Baseline to 6 months)
研究者
Vinicius Zacarias Maldaner da silva
Clinical Professor
Escola Superior de Ciencias da Saude