Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000063617
Ethics application status
Approved
Date submitted
22/09/2022
Date registered
18/01/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
18/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of a digital health model of care for the management of adults with symptomatic malignant pleural effusion
Scientific title
An evaluation of a digital health model of care for the management of adults with symptomatic malignant pleural effusion
Secondary ID [1] 307665 0
None
Universal Trial Number (UTN)
U1111-1280-9442
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Pleural Effusion 327194 0
Condition category
Condition code
Cancer 324331 324331 0 0
Lung - Mesothelioma
Cancer 324332 324332 0 0
Other cancer types
Respiratory 324985 324985 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324134 0
Treatment: Other
Comparator / control treatment
Conventional model (Melbourne Health and Western Health)

Participants (n=57) needing a pleural intervention will be prospectively followed over 6-months or death from study enrolment. Those undergoing indwelling pleural catheter will be managed according to local policy and procedures (this is not based on a specific guideline) by attending outpatient clinics at no set frequency. An audit will be undertaken monthly at the completion of the study to ensure all eligible patient are included in the final analysis. Data will be collected from the Melbourne Health and Western Health medical records, pathology, decision support, and the Centre for Victorian Data Linkage . All patient data will be de-identified and stored electronically (REDCap®) and password protected by the principal investigator on a secured network.
Control group
Active

Outcomes
Primary outcome [1] 332136 0
Pleural effusion-related hospitalisation (length of stay):

Hospitalisation for any causes (except for planned elective admissions non-pleural related issues e.g., chemotherapy, iron infusion, endoscopy etc.) will be recorded for all patients until time of death by review of medical records or participant reported during follow up.

Admission will be analysed as total admission days (and number of episodes) and as effusion-related admissions. The latter will include all hospitalizations for drainage purposes, for pleural related complications such as infection, symptomatic loculation and for removal of the indwelling pleural catheter (IPC) if indicated.

Two independent clinicians will review discharge summaries to determine if hospitalisation during the study period is ipsilateral pleural effusion related. Any disagreement will be resolved with a discussion to arrive to a consensus decision.
Timepoint [1] 332136 0
6 months post-enrolment or to death
Primary outcome [2] 332137 0
Overall Hospitalization % survival time from diagnosis (diagnosis of symptomatic MPE, recurrent MPE or intervention for recurrent MPE)

Length of stay for any cause (apart from elective admissions for chemotherapy) during follow-up period or until death. Data will be collected by review of medical records or participant reported during follow up.
Timepoint [2] 332137 0
6 months post-enrolment or to death
Primary outcome [3] 333517 0
Unplanned pleural effusion-related outpatient and Emergency Department (ED) visits:

Unscheduled clinic or ED visits for drainage purposes and IPC-related adverse events will be captured by review of medical records or participant reported during follow up.

Two independent clinicians will review outpatient and clinical documentation to determine if unplanned outpatient or ED visits are ipsilateral pleural effusion related. Any disagreement will be resolved with a discussion to arrive to a consensus decision.
Timepoint [3] 333517 0
6 months post-enrolment or to death
Secondary outcome [1] 412319 0
Survival:

Survival of all patients will be recorded from date of enrolment to death or end of study follow-up.

Data will be collected by review of medical records or participant reported during follow up.
Timepoint [1] 412319 0
6 months post-enrolment or to death.
Secondary outcome [2] 412322 0
Adverse events:

• Unplanned pleural related ED presentation
• Unplanned pleural related outpatient clinic visits
• Outpatient visits due to failure of home visits

Data will be collected by review of medical records or participant reported during follow up.
Timepoint [2] 412322 0
6 months post-enrolment or to death
Secondary outcome [3] 412323 0
Longitudinal health related quality-of-life using EQ-5D-5L, capability measure (ICECAP-A):
The EQ-5D-5L and the 100mm VAS-QoL has been successfully used in prospective MPE RCTs1,3,4 to assess quality of life measures in the monitoring of individuals with MPE. They will be measured at enrolment, prior to discharge and every 4 weeks until the end of follow-up or death.

Longitudinal HRQoL using EQ-5D-5L, capability measure (ICECAP-A) will be measured at baseline and during follow up that will occur at 2 weeks, 4 weeks and then monthly thereafter from diagnosis of MPE. The data will be collected via a prewritten case report form (CRF) at regular home visits.
Timepoint [3] 412323 0
Baseline, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 (post-enrolment)
Secondary outcome [4] 417387 0
Visual analog scale (VAS) for breathlessness and pain:

A logbook that contains a 100mm VAS will be used. This allows the patient to record their severity of breathlessness daily for 28-days. The VAS breathlessness is validated in the MPE population and has been successfully used in prospective MPE RCTs1-4.

The data will be collected via a prewritten case report form (CRF) at regular home visits.
Timepoint [4] 417387 0
Baseline, daily up to day 28 via log book (post-enrolement). This will be checked by the pleural nurse during follow up.
Secondary outcome [5] 417388 0
Pleural effusion-related hospital, nursing, and IPC resource utilisation - Frequency, duration, and cost-evaluation of nursing and medical contacts:

Resource use associated with IPC drainage, including drainage kits and drainage time by community and pleural nurse, will be recorded.

Data will be captured from local department coding data and community-based costs from patient data.

Healthcare utilisation which are pleural related will be obtained from hospital records and patient self-report, the latter at patient review sessions using a pre-specified questionnaire. Inpatient/outpatient management of complications will also be either captured in hospital records or obtained from patient self-report and will include treatments (e.g., antibiotics), diagnostic imaging and other interventions related to the adverse events.

For every study visit or additional home visit, the SAPS nurse will keep a record of the following:

1) distance travelled
2) hours on the road (time to destination and back to hospital)
3) cost of petrol
4) time spent with patient
5) any consumable used during home visits
Timepoint [5] 417388 0
Healthcare costs will be calculated from hospital records, data obtained from the Centre for Victorian Data Linkage and/or patient self-report at the conclusion of the follow up period.
Secondary outcome [6] 417389 0
Participant's Experience Using SAPS Digital Model of Care - Patient Activations Measure:

The Patient Activation Measure (PAM) is a validated tool measuring a patient’s skill, knowledge, and confidence in self-management. There are 4-levels of activation residing along an empirically derived, equal interval 100-point scale. The value of a single point change in PAM score is significant and well understood, as is the shift between levels.

The data will be collected via a prewritten case report form (CRF) at regular home visits.
Timepoint [6] 417389 0
PAM will be measured in all participants at enrolment, prior to discharge and at 3-months post-enrolment.
Secondary outcome [7] 417390 0
Participant's Experience Using SAPS Digital Model of Care - Survey to gather usability experience of this digital model of care:

This survey is based on the Health Information Technology Usability Evaluation Scale (Health-ITUES)22, a customisable questionnaire scale to measure usability of mobile health interventions. These questions are in 4 categories: Impact, Perceived Usefulness, Perceived ease of use and User control. It consists of 20 items rated on a five-point Likert scale from strongly disagree to strongly agree. A higher scale value indicates higher perceived usability of the technology. The overall Health-ITUES score is the mean of all the items with each item weighted equally. Survey will be developed online using REDCap® platform and conducted using a tablet during the home visits with participants.

The data will be collected via a prewritten case report form (CRF) at regular home visits.
Timepoint [7] 417390 0
Baseline, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 (post-enrolment)
Secondary outcome [8] 417391 0
Participant's Experience Using SAPS Digital Model of Care - Semi-structured qualitative interview to understand patient experience:

Semi-structured interviews will be undertaken with consecutive study participants invited to participate at the intervention site (NH) unless there is an exclusion criteria. In total, it is anticipated that 12-16 participant interviews of an expected duration of one hour will be performed to determine patient experience at 4-weeks after a definitive procedure. Interviews will be performed by a research clinician trained in interviewing who are not otherwise involved in the patient’s care. One interviewer will perform all the interviews to ensure consistency of approach.

A patient interview guide has been developed and will be followed to ensure all relevant survey factors are explored to understand their experience using this model of care. The questions in this guide are developed using Health Information Technology Usability Evaluation Model (Health-ITUEM), a validated usability evaluation model for mobile health Interventions, that explores User Satisfaction, Perceived Ease of Use, Perceived Usefulness, Efficiency and Effectiveness factors. It is an Integrated model of multiple theories as a comprehensive usability evaluation framework. Also included within this patient interview guide is a Distress Protocol explaining how interviewers will react if an interview participant experiences distress during an interview.

Participants recruitment for interviews will cease once theme saturation has occurred (anticipated to be n=12-16). Additional participants will be invited to participate in the interviews if theme saturation is incomplete. Interviews will be audio-recorded, transcribed verbatim by a trained independent investigator conducting the interviews, anonymised, and analysed independently using framework method for the analysis of this multidisciplinary qualitative data. Framework analysis uses the following five stages to analyse qualitative data: familiarisation, identification of themes, indexing (coding), charting and summarising, interpretation/ mapping.28
The interview guide analysis will focus on the key benefits, risks, and barriers to expansion of the SAPS model around the following areas:

o Impact / Health service (SAPS model-of-care) experience
o Accessibility support from the medical/ nursing team
o Quality of life and symptom monitoring
o Understandability of education regarding the management of MPEs

The data will be collected via a prewritten case report form (CRF) at this interview.
Timepoint [8] 417391 0
4-weeks after definitive procedure.
Secondary outcome [9] 417392 0
SAPS Nurse Experience in Digital Model of Care:

• Survey

This survey is based on the Health Information Technology Usability Evaluation Scale (Health-ITUES), a customisable questionnaire scale to measure usability of mobile health interventions. These questions are in 4 categories: Impact, Perceived Usefulness, Perceived ease of use and User control. It consists of 20 items rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). A higher scale value indicates higher perceived usability of the technology. The overall Health-ITUES score is the mean of all the items with each item weighted equally.22 A nurse version of this survey is in Appendix 6.
Survey will be developed online using REDCap® platform and conducted using a tablet post-home visits with participants.

• Semi structured interview

Semi-structured interview will be conducted with the SAPS nurse to understand the experience in using the SAPS model of care at the intervention site (NH). Interview guide is available in and has two parts to it:

1. Comfort and training experience:
A demographic form consisting of six questions (gender, training level, nursing certification, pervious ultrasound experience, years of prior ultrasound experience and years of prior nursing experience) and a five-point Likert scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree) survey consisting of five questions describing perception of the training experience and comfort level obtaining point of care ultrasound (POCUS) images post-training.
Questions:
1) Prepared to perform ultrasound given training received
2) Ultrasound experience considered positive
3) Comfortable using ultrasound prior to training
4) Comfortable using beside ultrasound after training

2. Usability Experience in using digital care pathway (SAPS model of care):
Semi-structured interview of the SAPS nurse will be conducted by a research clinician trained in interviewing who is not otherwise involved in the participant’s care. It will be conducted to reflect the experience being involved with the SAPS model-of-care at the intervention site (NH). An interview guide has been developed and will be followed to ensure all relevant survey factors are explored to understand their experience using this model of care over the study period. The questions in this guide are developed using Health Information Technology Usability Evaluation Model (Health-ITUEM), a validated usability evaluation model for mobile health interventions, that explores user satisfaction, perceived ease of use, perceived usefulness, efficiency, and effectiveness factors. It is an integrated model of multiple theories as a comprehensive usability evaluation framework.

The interview guide will also focus on the key benefits, risks, and barriers to expansion of the SAPS model around the following areas:
a. Health service (SAPS model-of-care) experience
b. Accessibility support from the medical team
c. Home visits and patient monitoring
d. Understandability of education regarding the management of MPEs.
Timepoint [9] 417392 0
The survey and interview on the SAPS nurse’s experience, comfort, usability and training experience will be completed at baseline (prior to enrolling the first patient) and after the enrolment of the 5th patient.

Usability experience with the SAPS model of care will be done monthly collection and tracking of survey data to help understand nurse experience with this digital care pathway over a period of 6-months.
Secondary outcome [10] 417393 0
Evaluation of Digital Care Pathway Implementation by Expert Panel and Document review:

• Expert Panel
Discussion and reporting of this digital model implementation experience against criteria of WHO mobile health (mHealth) evidence reporting and assessment (mERA).

• Document Review
Analyse and compile nurses and patients' experiences (interviews and survey) with expert panel report to understand evaluation of this model of care.
Timepoint [10] 417393 0
Expert panel session will be conducted in the 6th month of data collection.

Document review will be conducted during data analysis.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size:
This study will be powered to detect a difference of 6-days or more spent in hospital between the groups (80% power; a=.05) based on the AMPLE-1 study led by CI-Lee, with the estimated mean in the control group considered to be 12 (SD,12) days based on a one-sided test. There is no established minimal clinically important difference for this end point, but a reduction in the mean days of 50% is considered as the difference to detect underlying this sample size calculation. A total sample size of N=114 will be required (n=57 per group). The overall recruitment target of 114 allows for a lost-to-follow-up rate of approximately 10%. Specialised ambulatory pleural unit led by PI-Muruganandan sees four individuals with malignancy pleural effusion a month. Approximately 75% of them will fulfil the inclusion criteria allowing recruitment to complete in 18-months.

Statistical methods:
a) Statistical analysis
Data analysis is on an intention-to-treat basis overseen by Mr Mark Tacey. The primary outcome will be analysed using a Mann-Whitney (rank-sum) test with subsequent non-parametric regression analyses to adjust for any noted characteristic or clinical differences between the intervention and control group. For the secondary outcomes, the difference between the groups will initially be examined using two sample t-tests if normally distributed, via Mann-Whitney (rank-sum) tests considered for non-normally distributed variables, or using Fisher’s Exact tests if categorical.
b) Health-economic analysis
The economic evaluation will be a cost-effectiveness analysis comparing differences in costs and quality adjusted life years (QALYs) between the groups over the duration of the trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2023
Actual
5/09/2023
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
114
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22878 0
The Northern Hospital - Epping
Recruitment hospital [2] 22880 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 26724 0
Eastern Health - Box Hill
Recruitment hospital [4] 26725 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 38183 0
3076 - Epping
Recruitment postcode(s) [2] 38185 0
3050 - Parkville
Recruitment postcode(s) [3] 42765 0
3128 - Box Hill
Recruitment postcode(s) [4] 42766 0
3350 - Ballarat Central

Funding & Sponsors
Funding source category [1] 311934 0
Charities/Societies/Foundations
Name [1] 311934 0
HCF Research Foundation
Country [1] 311934 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper Street
Epping
Victoria
3076
Country
Australia
Secondary sponsor category [1] 313415 0
None
Name [1] 313415 0
Address [1] 313415 0
Country [1] 313415 0
Other collaborator category [1] 282374 0
Commercial sector/Industry
Name [1] 282374 0
Rocket Medical Pty Ltd
Address [1] 282374 0
Rocket Medical Pty Ltd
Suite 6, 157 Gordon Street,
Port Macquarie.
NSW 2444. Australia
Country [1] 282374 0
Australia
Other collaborator category [2] 282375 0
Commercial sector/Industry
Name [2] 282375 0
Philips Healthcare Australia
Address [2] 282375 0
Philips Healthcare Australia
65 Epping Rd
Macquarie Park
NSW 2113
Country [2] 282375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311367 0
Human Research Ethics Committee - Royal Melbourne Hospital
Ethics committee address [1] 311367 0
Ethics committee country [1] 311367 0
Australia
Date submitted for ethics approval [1] 311367 0
27/09/2022
Approval date [1] 311367 0
01/06/2023
Ethics approval number [1] 311367 0
2022.290

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120850 0
Dr Sanjeevan Muruganandan
Address 120850 0
Northern Health
185 Cooper St
Epping
3076
Victoria
Country 120850 0
Australia
Phone 120850 0
+61 03 84052446
Fax 120850 0
Email 120850 0
sanjeevan.muruganandan@nh.org.au
Contact person for public queries
Name 120851 0
Sanjeevan Muruganandan
Address 120851 0
Northern Health
185 Cooper St
Epping
3076
Victoria
Country 120851 0
Australia
Phone 120851 0
+61 03 84052446
Fax 120851 0
Email 120851 0
sanjeevan.muruganandan@nh.org.au
Contact person for scientific queries
Name 120852 0
Sanjeevan Muruganandan
Address 120852 0
Northern Health
185 Cooper St
Epping
3076
Victoria
Country 120852 0
Australia
Phone 120852 0
+61 03 8405 2446
Fax 120852 0
Email 120852 0
sanjeevan.muruganandan@nh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.