Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Fidelity of intervention delivery
研究概览
简要总结
To investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of ArtiQ.Spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry
详细描述
This is a feasibility study for a larger multicentre randomised controlled trial (RCT) assessing the impact of the ArtiQ.Spiro software on diagnostic accuracy, care processes, patient and health economic outcomes.
The primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry.
Endpoints of the current study will be focused on feasibility and acceptability outcomes.
Secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. This will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power.
This is a mixed methods randomised controlled feasibility trial. In PICO format:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Adults ≥18 years, irrespective of sex, ethnicity, disability, sexual orientation, marital status, educational level,
- •Referral by GP or nominated representative for primary care spirometry during study period.
- •Patients able to provide informed consent.
排除标准
- •Age <18yrs; Absolute contraindication to spirometry.
- •Any locally defined exclusion to spirometry.
结局指标
主要结局
Fidelity of intervention delivery
时间窗: Six months
Contributing data: Email Logs, and Primary Care Referrer Questionnaire. Progression Criteria: Green (≥90% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, ≥90% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Amber (85-94% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, 75-89% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Red (\<85% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, \<75% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation).
Acceptability of outcome measures and their timing
时间窗: Six months
Contributing data: Stakeholder focus groups, and Clinical Outcome Measure collection. Progression criteria: Green (Reported as acceptable or can be with minimal modification, Missing data of ≤10% for each measure).Amber (Reported as acceptable with modification, 11-25% missing data for each measure). Red: (Intervention not acceptable, \>25% missing data for each measure).
Participant retention at follow-up
时间窗: Six months
Contributing data: Participation data and Trial Consort diagram. Progression criteria: Green (≥75% retained at 3 months, ≥60% retained at 6 months), Amber (60-75% retained at 3 months, 40-59% retained at 6 months), Red (\<60% retained at 3 months, \<40% retained at 6 months).
Contamination of control groups
时间窗: Six months
Contributing data: Email Logs. Progression Criteria: Green (≤10% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report). Amber (11-15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report) Red (\>15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report)
Identification and recruitment of eligible participants
时间窗: Six months
Contributing data: Screening \& recruitment log and trial consort diagram. Progression criteria: Green (≥80% screened eligible, ≥60% eligible recruited), Amber (60-79% screened eligible, 40 - 59% eligible recruited), Red (\<60% screened eligible, \<40% eligible recruited)
Fidelity of randomisation
时间窗: Six months
Contributing data: Numbers randomised to control/intervention groups and baseline distribution of characteristics of intervention and control groups. Progression criteria: Green: \<10% difference in sample size, proportion of women, proportion of non-white ethnicity, proportion of \> 65 years between control/intervention for each site. Amber: \<15% difference in above criteria; Red: \>15% difference in above criteria.
Acceptability of the intervention to referrers, spirometry practitioners and participants
时间窗: Six months
Contributing data: Stakeholder focus groups. Progression criteria: Green (Reported as acceptable (or can be with minimal modification). Amber (Reported as acceptable with modification).Red (Intervention not acceptable).
Diagnostic accuracy of ArtiQ.Spiro compared with reference standard
时间窗: Six months
Contributing data: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard. Progression criteria: Green: ≥ 80%, Amber: 65-79%, Red: \<65%.
Data collector blinding
时间窗: Six months
Contributing data: Participation data. Progression criteria: Green (Blinding maintained for ≥85% participants), Amber (Blinding maintained for 84-70%), Red (Blinding maintained for \<70%).
次要结局
- Primary Care Referrer Quality Assessment Confidence(Six months)
- Primary Care Referrer Technical/Pattern Interpretation(Six months)
- Patient health status(Six months)
- Primary Care Referrer Technical/Pattern Interpretation Confidence(Six months)
- Spirometry Quality Assessment Performance (vs Reference Standard)(Six months)
- Primary Care Referrer Diagnostic Performance (versus Reference Standard)(Six months)
- Primary Care Referrer Diagnostic Confidence(Six months)
- Health economic modelling(Six months)
- Focus groups(Six months.)
- Heath and social care usage(Six months)