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Clinical Trial
. 2025 Jun 18;13(6):e70194.
doi: 10.1002/rcr2.70194. eCollection 2025 Jun.

Evaluation of a Digital Health Model of Care for the Management of Adults With Symptomatic Malignant Pleural Effusion

Victor Duong  1   2 , Kirstin Tirant  1 , Urooj Raza Khan  3 , Pierce Marsden  1 , Daniel Steinfort  2   4 , Nicholas Wilsmore  5 , Wasek Faisal  6 , Mani Suleiman  7 , An Tran-Duy  8   9 , Paul Amores  8   9 , Liam M Hannan  1   2   10 , Sanjeevan Muruganandan  1   2
Affiliations
Clinical Trial

Evaluation of a Digital Health Model of Care for the Management of Adults With Symptomatic Malignant Pleural Effusion

Victor Duong et al. Respirol Case Rep. .

Erratum in

Abstract

Background: The management of malignant pleural effusion (MPE) is inconsistent across health services. Many centres do not routinely offer all treatment options for MPE, with indwelling pleural catheter (IPC) being a primary example. This may be due to lack of specialist expertise or nursing capability to support the community-based treatment. New approaches are required to improve access to MPE treatments. This proof-of-concept study examines the feasibility of a virtual model of care for MPE, known as the specialist ambulatory pleural service (SAPS) model of care. This model will be compared with current approaches at other health services in the state, in terms of healthcare utilisation and costs. It will also assess health-related quality of life in individuals with MPE and report patient, carer and nurse experiences with the SAPS model of care.

Methods: A prospective, multi-centre, mixed-methods study will be performed. Participants with symptomatic MPE requiring intervention will be consecutively enrolled. The primary outcome is pleural effusion-related hospitalisation from enrolment to death or end of study participation. Secondary outcomes include: Overall hospitalisation, unplanned pleural effusion-related outpatient and emergency department (ED) visits, pleural-related healthcare costs, adverse events, overall survival, percentage of screened patients recruited, percentage dropped out/lost to follow up, percentage of scheduled home visits carried out, percentage of teleultrasound assessments completed, technical issues, percentage of symptom logbooks completed, quality of life, longitudinal symptom monitoring, participant and nursing attitudes to the SAPS model of care, patient activation measure and a stakeholder interview of the SAPS model of care implementation.

Discussion: Digital health may improve access to MPE treatments by reducing barriers to specialist care and facilitating training and support for community staff. This trial assesses the SAPS model of care, providing data on barriers and facilitators to its implementation, its efficacy, costs and qualitative outcomes. Trial Registration: Australia New Zealand Clinical Trial Registry: ACTRN12623000063617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384448&isReview=true.

Keywords: digital health; malignant pleural effusion; nursing care; patient‐reported outcomes; teleultrasound.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
The proposed SAPS model of care.
FIGURE 2
FIGURE 2
Project overview.
FIGURE 3
FIGURE 3
Pathway for managing MPE‐related concerns under the SAPS model of care.
FIGURE 4
FIGURE 4
Standard operating procedure (SOP) for diagnosing non‐expandable lung.
FIGURE 5
FIGURE 5
Standard operating procedure (SOP) for establishing spontaneous pleurodesis in individuals with IPC.
See this image and copyright information in PMC

Comment in

References

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