Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Cost
研究概览
简要总结
This is a study to determine how a virtual model for the management of lung nodules compares to a face-to-face clinic for patient satisfaction, quality of life and cost.
详细描述
Initial Steps:
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Individuals that have been referred to the Respiratory Outpatient Department of Flinders Medical Centre for management of a lung nodule will have their referral data screened by a doctor to determine that the referral meets criteria for management in the outpatient department and which category of follow-up is required (triaging process).
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Eligible referrals will be provided to the study's research assistant who will contact the individual to discuss the study in detail and obtain consent to participate.
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Individuals that have consented to participate are randomly assigned to either the 'virtual model' of lung nodule management (a), or the 'face-to-face model' of lung nodule management (b). Each participant has a 50% chance (1 in 2) of being assigned to either group.
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The 'virtual model' involves participants' CT scan(s) being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse these scans and make a recommendation for any follow-up scans, procedures or appointments that may be required. The team will contact each participant with a phone-call. Participants primary care providers will also receive a letter describing the review and plan. Participants are not required to physically attend the hospital or outpatient department for this review to occur.
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The 'face-to-face model' involves a face-to-face appointment in the Respiratory outpatient clinic at Flinders Medical Centre, where a doctor will review participants' CT scan(s) and make a plan for any follow-up scans, procedures or appointments that may be required. Primary care providers will be informed of the outcome of this visit. Participants are required to physically attend the clinic appointment for this review.
All participants in this research study will be asked to complete an initial set of two questionnaires. The questionnaires include:
- Participant information questionnaire - collects personal information and contact details, as well as specific health-related, occupational and lifestyle information.
- Hospital Anxiety and Depression Scale (HADS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •At least 1 IPN identified on CT imaging measuring 4-30 mm in maximal diameter
- •CT slice thickness of 3 mm or less
排除标准
- •Previous diagnosis of lung cancer
- •History of haemoptysis
- •Unexplained weight loss > 7 kg in the preceding 12 months
- •Past history of malignancy within 5 years (excluding non-melanoma skin cancer)
研究组 & 干预措施
Virtual multidisciplinary review
Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team
干预措施: Virtual multidisciplinary review (Other)
Face-to-face review
Participants in this group will be reviewed in a face-to-face clinic
结局指标
主要结局
Cost
时间窗: 6 months
Economic cost to participants and our health service, measured by an investigator-derived questionnaire asking participants to describe time spent engaging in the their health care and any direct costs associated with visits. Economical modelling will also be applied to determine the staffing and resource costs associated with provision of care to participants in each arm.
次要结局
- Participant satisfaction(6 months)
- Anxiety(6 months)