A Cluster-randomized Trial of Point-of-care PCR Diagnostics of Respiratory Tract Infections in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,700
- 试验地点
- 2
- 主要终点
- Reduction of respiratory tract infections (RTI) patients' re-contacts to General Practitioners
研究概览
简要总结
The present study will assess the effect and cost-effectiveness of the availability of point-of-care (POC) PCR testing, in respiratory tract infections (RTIs) in general practice, compared with usual care.
详细描述
Background: Respiratory tract infections (RTIs) are frequent reasons for medical consultations and diagnostic accuracy is important to ensure appropriate treatment. It is important for the quality of the healthcare system that patients are diagnosed as fast as possible and that the GP and the patient are reassured about the diagnostic accuracy. If not, the patient may be unnecessarily concerned and contact health services again.
Re-contacts are costly for society, but they may also be unsatisfactory to the patient and the clinician, because many re-contacts may indicate that tentative diagnosis or treatment were not successful and that in some cases the patient needs to contact health services again to get a sufficient answer or to be reassured that nothing is dangerous.
The introduction of POC PCR in primary care settings has demonstrated significant improvements in appropriate antibiotic prescription patterns in high income countries. In Denmark around 88 pct. of all prescription drugs are issued by general practice, as is the vast majority of the total antibiotics consumption in the healthcare system.
Antibiotic overuse may lead to microbial resistance and if the overall consumption is not reduced, infections with resistant bacteria will be a major problem for both patients and healthcare systems. Due to diagnostic uncertainty, GPs may in some situations prescribe antibiotics also in cases where the patient's symptoms are caused by a viral infection.
Further, if antibiotics are not prescribed, the patient may reconsult their GP or the out-of-hours services due to feelings of uncertainty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reduction of respiratory tract infections (RTI) patients' re-contacts to General Practitioners
时间窗: 2 x 7 weeks of trial = 14 weeks in total (exclusive crossover)
The primary outcome measure is change in the number of re-contacts within a time period of 7 days from initial contact for each patient consulting with a clinic for a RTI in the intervention period compared to the control period. The re-contacts include any daytime contacts to general practice and are based on data from the national Danish registries. RTI patients may present themselves with symptoms often associated with RTI, e.g., fever, cough, sore throat etc., but it is up to the treating clinician to categorize patients as having a RTI. Each time period (i.e., intervention and control) consists of 7 weeks.
次要结局
- Change in number of hospital admission and deaths(Within a time period of 14 days from initial contact for a respiratory tract infection)
- Productivity costs based on WPAI-GH-questionnaires(Productivity loss will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.)
- Cost-effectiveness(Within 28 days)
- Cost-utility(Within 28 days)
- Change in number of redeemed antibiotic prescriptions(Within a time period of 7 days from initial contact for a respiratory tract infection)
- Effect of POC PCR in general practice on patient satisfaction based on patient satisfaction questionnaires.(On the initial contact for RTI (baseline))
- Effect of POC PCR in general practice on GP satisfaction based on GP satisfaction questionnaires(At the end of trial (through study completion, an average of 23 weeks))
- Total treatment costs 28 days from the initial contact for RTIs based on data from Danish national registers(28 days from the initial contact for RTI)
- Health-related quality of life (EQ-5D-5L)(HRQoL will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.)
- Qualitative process evaluation(Prior and during the 14 weeks study period)