Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 836
- 试验地点
- 58
- 主要终点
- Time to first cardiovascular-related consultation
研究概览
简要总结
This study aimed to analyze and investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to evaluate time savings and cost saving implications of increased availability of specialised care at the primary care level.
详细描述
It is a multi-centric, physician-driven, patient-blinded randomized controlled trial of patients presenting to the general practitioner with typical cardiovascular symptoms (specifically, chest pain, syncope, palpitations, or shortness of breath) constituting an electrocardiogram examination. Eligible patients will be enrolled at the participating general practitioner clinics and managed either through the PMcardio platform with AI-assisted diagnostics, patient management recommendations or usual standard of care throughout their initial visit. Enrolled participants will be followed-up through health insurance billing codes and there will be no personal follow-up visits required. The aim of the study is to investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to assess time savings and cost saving implications of increased availability of specialised care at the primary care level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 55 years or above.
- •Participant is willing and able to give informed consent for participation in the study.
- •Presenting to the GP with ANY of the following cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath.
- •Patients insured by Dôvera ZP or Union ZP health insurance providers.
排除标准
- •Reason for doing the ECG at the GP clinic is a routine examination or pre-operative assessment.
- •Participant does not present with cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath.
- •Participant is already included in the study due to a prior GP visit throughout the trial period (e.g., participant comes for a second visit to GP clinic due to cardiovascular symptoms).
- •Patients insured by VšZP health insurance provider
- •Female participants who are pregnant, lactating or planning pregnancy during the study.
- •Any other significant comorbidity, disease, or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
结局指标
主要结局
Time to first cardiovascular-related consultation
时间窗: From randomization to enrollment period completion (up to 6 months)
Time from randomization to the first cardiovascular-related consultation or a follow-up visit at specialized physician in patients, where specialized consultation is indicated based on the general practitioner recommendation after using PMcardio application. The measurement will be assessed from the data received from the health insurance provider.
Time to first cardiovascular-related diagnostic testing
时间窗: From randomization to to enrollment period completion (up to 6 months)
Time from randomization to the first cardiovascular-related further diagnostic testing (laboratory parameters, ECG Holter, echocardiography).The measurement will be assessed from the data received from the health insurance provider
Time to first cardiovascular-related drug prescription
时间窗: From randomization to to enrollment period completion (up to 6 months)
Time from randomization to the first cardiovascular-related drug prescription in patients, where drug prescription is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider
Time to first cardiovascular-related hospitalization
时间窗: From randomization to to enrollment period completion (up to 6 months)
Time from randomization to the first hospitalization in patients, where hospitalization is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider
次要结局
- Cost-effectiveness ratio and effect on cost savings(1 year)
- Reliability and safety of the PMcardio measured by system failures(From the very first participants randomization to total follow-up time (up to 6 months))
- Reliability and safety of the PMcardio measured by system up-time(From the very first participants randomization to total follow-up time (up to 6 months))
- General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).(From randomization to study completion (up to 1 year))