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An evaluation of a digital health model of care for the management of adults with symptomatic malignant pleural effusion

An evaluation of a digital health model of care for the management of adults with symptomatic malignant pleural effusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000063617
Enrollment
114
Registered
2023-01-18
Start date
2023-09-05
Completion date
2025-07-25
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have symptomatic malignant pleural effusion that requires treatment, you are currently being looked after by the Pleural Medicine Service at Northern Health, and have recently undergone a procedure to manage the fluid around the lung. Study details: The trial aims to include 114 participants, 57 who will be cared for with the Specialised Ambulatory Pleural Service digital health care model at Northern Health. The hospital records of a further 57 individuals receiving standard care will be reviewed from Melbourne Health and Western Health to compare hospital admissions, emergency presentations, and outcomes. Participants in the intervention group will receive aftercare by a treating physician and a pleural nurse. The pleural nurse will visit at home, to provide care for the indwelling pleural catheter. At each visit a lung ultrasound will be performed. The treating physician will view the ultrasound remotely (tele-ultrasound) and do a video call (tele-health) to provide an assessment of the fluid around the lungs. The visits will occur at days 14 & 28, and months 2, 3, 4, 5 and 6. Being involved also requires completion of a logbook to monitor symptoms for 28 days and participation in surveys at during the routine home visits. Participants will also be asked about health care outcomes, such as whether they have recently been to hospital or emergency department. Participants may be selected for an interview via telephone or internet video call that should take approximately an hour. Hospital records will be accessed related to hospital admissions, emergency presentations, and outcomes for the purpose of comparing the benefits and risks of this model of care to standard care at other health services. It is hoped this research will demonstrate that a specialised pleural service where participants may receive treatment at home is safe and can be achieved in a practical manner. If this initial study shows that this service is feasible, it may be rolled out to additional hospitals and could lead to improved quality of life for patients who are being treated for malignant pleural effusion.

Interventions

Specialist ambulatory pleural service (SAPS) model-of-care at Northern Health SAPS will manage participants (n=57) with confirmed malignant pleural effusion based on the treating physicians discretion. Consecutive participants individuals with malignant pleural effusion (MPE) will be offered trial entry and will be enrolled after providing informed consent. Personalized education by the primary physician as part of a standard clinic appointment, pamphlets (on MPE and type of procedure) and Ind

Specialist ambulatory pleural service (SAPS) model-of-care at Northern Health SAPS will manage participants (n=57) with confirmed malignant pleural effusion based on the treating physicians discretion. Consecutive participants individuals with malignant pleural effusion (MPE) will be offered trial entry and will be enrolled after providing informed consent. Personalized education by the primary physician as part of a standard clinic appointment, pamphlets (on MPE and type of procedure) and Indwelling Pleural Catheter (IPC) consumables (if required) will be provided. The intervention will involve ambulatory aftercare by a treating physician and a pleural nurse. The pleural nurse will visit at home (~ 1 hour), to provide care for the indwelling pleural catheter. At each visit a lung ultrasound will be performed. The ultrasound device used, also enables video calls to be made. The treating physician will view the ultrasound remotely (tele-ultrasound) and do a video call (tele-health) to provide an assessment of the pleural effusion. The visits will occur at days 14 & 28. Months 2, 3, 4, 5 and 6 after which the subject can continue being treated by this model-of-care if they prefer. Being involved also requires completion of a logbook to monitor symptoms for 28 days and participation in surveys at during the routine home visits. Survey questions will include self-evaluating wellbeing, rating how comfortable you are with self-management of your catheter drain, reporting on how easy technology was to use, and rating levels of mobility, self-care, or discomfort. The subject will also be asked about health care outcomes, such as whether they have recently been to hospital or emergency department. Subjects may be selected for an interview via telephone or internet video call that should take approximately an hour. During this interview we will ask about their experience of the care provided by the Specialist Ambulatory Pleural Service: how accessible was the support from Specialist Ambulatory Pleural Service medical/nursing team, and did you find the queries were often answered; how did you find doing the questionnaires: was it burdensome or too frequent; was the education material accessible and understandable. This interview will be performed by an independent clinician trained in interviews for research from outside of Northern Health to reduce bias. Participants will also be given a mobile contact (pleural mobile) which is active 24 hours 7-days a week if there is any worsening of symptoms and troubleshooting of indwelling pleural catheter. Hospital records will be accessed related to hospital admissions, emergency presentations, and outcomes for the purpose of comparing the benefits and risks of this model of care to standard care at other health services. Follow up will continue for 6 months or to death.

Sponsors

Northern Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Individuals with a symptomatic malignant pleural effusion requiring a therapeutic intervention Age of 18 years or older Inpatients or outpatients at Northern, Melbourne or Western Health Diagnosis of Malignant Pleural Effusion

Exclusion criteria

Individuals who home visits cannot be done safely will be transitioned to standard of care (i.e., outpatient clinic visits). At the intervention site (NH), individuals who are too medically unwell or with cognitive impairment will be excluded from the need to complete questionnaires/surveys, and interviews.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026