Virtual Management of Lung Nodules

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04892524
• Other study ID #: SALHNLungNodules
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: Southern Adelaide Local Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Initial Steps:

1. 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).

2. 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.

3. 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.

1. 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.

2. 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)

Once participants have had their face-to-face appointment or virtual review, they will be asked to complete four questionnaires at a 1-month and 3-month interval. The questionnaires include:

• Hospital Anxiety and Depression Scale (HADS)

• Patient experience questionnaire

• Patient economic impact questionnaire

• Modified Visit-specific satisfaction instrument (VSQ-9)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: October 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Other:
• Virtual multidisciplinary review
The virtual multidisciplinary review involves participants being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse radiologic scans and make a recommendations for any follow-up scans, procedures or appointments that may be required

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Southern Adelaide Local Health Network

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost	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.	6 months
Secondary	Participant satisfaction	Participant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)	6 months
Secondary	Anxiety	Participant anxiety as measure by the Hospital Anxiety and Depression Scale (HADS), which is a questionnaire containing seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.	6 months