Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001239550
Ethics application status
Approved
Date submitted
29/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A primary care multi-disciplinary team care approach, including pulmonary rehabilitation, to address uptake and outcomes of comprehensive evidence-based care for Chronic Obstructive Pulmonary Disease (COPD) (MDT-PuRe-Primary Care).
Scientific title
A primary care multi-disciplinary team care approach, including pulmonary rehabilitation, to address uptake and outcomes of comprehensive evidence-based care for Chronic Obstructive Pulmonary Disease (COPD) (MDT-PuRe-Primary Care).
Secondary ID [1] 312667 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MDT-PuRe-Primary Care
Linked study record
This study expands upon the pilot study ACTRN12622001501730, which is the pilot for the PuRe component of the study only.
The pilot study for the m-PR intervention, which is an option presented to participants is ACTRN12619001253190,
This study ACTRN12617001337369 informs the modification of the PuRe component for Aboriginal populations.
This study ACTRN12622000568718 informs the modification of the nurse delivered MDT component.

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 334643 0
Condition category
Condition code
Respiratory 331224 331224 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 331225 331225 0 0
Other physical medicine / rehabilitation
Public Health 331287 331287 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this two by two factorial design trial is to evaluate the implementation, effectiveness, and cost-effectiveness of two new healthcare strategies (services) to improve the provision of evidence-based management for people with COPD compared with usual GP management of COPD. The two new strategies are to:
1) Upskill registered nurses to provide Multi-Disciplinary Team (MDT) care planning with the General Practitioner (GP) for people with COPD
2) Provide access to an 8-week PUlmonary REhabilitation program in Primary Care (PuRe Primary Care) delivered by private Exercise Physiologists (EPs) or Physiotherapists (PTs) in the community.
Patients will be randomised to one of four groups which include combinations of the two implementation strategies.
Arm 1: MDT Care (Strategy 1) & PuRe Primary Care (Strategy 2)
Arm 2: MDT Care (Strategy 1) & Usual PR (Control Strategy 2)
Arm 3: Usual GP Care (Control Strategy 1) & PuRe Primary Care (Strategy 2)
Arm 4: Usual GP Care (Control Strategy 1) & Usual PR (Control Strategy 2)

Strategy 1: MDT Care delivered by a General Practice Nurse (GPN), Nurse Practitioner (NP) or Aboriginal Health Worker (AHW), as determined by the participating health services. The GPN/NP/AHW will conduct a tailored, multi-component self-management program. The GPN/NP/AHW will work with the patient to systematically address patients’ beliefs, perceived benefits of action and barriers to action, self-efficacy (engagement or lack of engagement) and use stimuli (cues to action) to trigger COPD self-management behaviours. The program will be tailored based on patients’ individual demographics, priorities and motivation to ensure that the level of support provided is appropriate to the needs of the participants and engagement in change will be supported using motivational interviewing. The GPN/NP/AHW will deliver the intervention through an initial assessment visit (virtual or face to face) followed by two health coaching sessions (about 45 minutes each) spaced four weeks apart. Following the last session, PNs will provide a summary of the program for the patient and their GP. This is adapted from ACTRN12622000568718.

The patients will attend three visits a month apart. The first visit will be virtual with options for face-to-face in one if preferred, and subsequent visits will be virtual. This strategy has been developed and successfully tested by members of the research team. The first visit will involve developing an individualised COPD plan. Prominent focus topics for said plan include understanding the COPD diagnosis and diseases process, managing COPD symptoms and flare-ups, and long term management of health conditions. In subsequent visits, the GPN/NP/AHW will assess compliance with the plan and provide supportive strategies including motivational intervewing. Session adherence will be collected by the nurse and provided to the research team. No other adherence data will be collected. At the end of the intervention with the GPN, a report based on a care plan will be sent to the GP detailing the care provided. If the GPN / GP prefer, they can also include a verbal handover. Each visit will take approximately 45-60 minutes to complete.

Strategy 2: PuRe Primary Care, patients will be provided with a referral to the Pulmonary Rehabilitation (PR) program provided in primary care in their local area from the research assistant and an appointment booked for the initial assessment. The PR program has been developed from the recommendations from the outcome of the Medical Services Advisory Committee (MSAC) application and is currently being piloted by a PhD student (ACTRN12622001501730). The PR program consists of:
1. An initial assessment which includes an assessment of blood pressure pre and post the exercise capacity test. The exercise capacity test will be either an incremental shuttle walk test (ISWT) and a one sit to stand testfollowing standard protocols. The choice of test will be determined by the space available in the EP/PT practice. The assessment will take approximately 30 minutes. Preliminary data from the pilot PhD project indicate that the ISWT is most frequently used as it requires a smaller space. Prior to conducting an exercise test or exercise session, each participant will have a subjective assessment performed and have baseline observations of blood pressure, heart rate and oxygen saturation conducted. Any contra-indications to exercise will mean that the exercise test or session will not proceed, and the participant will be referred for medical review by their GP as appropriate.

2. The assessor or clinician delivering the intervention will monitor all participants throughout the assessments and intervention exercise sessions. If a participant experiences an adverse event while undertaking any study-related procedures, the safety procedure will be followed at all times and the adverse event documented. During the assessments, patients will be monitored with blood pressure, blood oxygen, and heart rate pre, during and post testing, as well as pre, during and post exercise. Patients will be continually monitored by the clinician by Borg scale to assess breathlessness and fatigue.

3. The PR program will consist of three exercise sessions (one at home) per week for 8-weeks prescribed by private practice EPs/PTs. The exercise program will include endurance exercises and upper/lower limb functional strength exercises prescribed at an appropriate intensity based on a baseline incremental shuttle walk test (ISWT) and will be progressed accordingly during the PR program. Exercise selection will also be determined by the equipment available at the practice. Examples of exercises include treadmill or ground walking, stationary cycling, as well upper and lower limb strengthening exercises using resistance bands or free weights. The exercise sessions will take approximately 1 hour.

4. Patient education will use COPD Online Patient Education (C.O.P.E) https://cope.lungfoundation.com.au/ developed by LFA and/or the education videos developed within the ‘mobile pulmonary rehabilitation program’ (m-PR). C.O.P.E. uses short videos, and interactive sections to lead the patient through several modules, including; Understanding your lungs and COPD, Managing your medicine and symptoms, How you can better help yourself, Physical activity and exercise, and Living with a lung disease. The program finishes with a post-program knowledge questionnaire. Patients will be instructed to complete the education program.

5. There is an additional option for participants to complete the program virtually via Perx m-PR (or a hybrid of face-to-face and m-PR) depending on location and patient preference. The m-PR program has been developed by the researchers and is being tested in a randomised controlled trial in Northern Sydney LHD. If the patient chooses to use the m-PR, their EP/PT will upload their personalised exercise program into the app through the clinician portal. Patients will be able to record their exercise progress in the m-PR app which will be visible to their treating EP/PT. The m-PR clinician portal allows the physical therapist to track each participant’s progress and individualize the participant’s exercise and education program,

6. Maintenance exercise is beyond the scope of this intervention, however clinicians will refer to local maintenance options after completing the PR program, as this is what evidence-based practice encourages. Uptake in maintenance exercise will be encouraged through:
i) Lungs in Action;
ii) m-PR maintenance; or
iii) home exercise prescription.
Intervention code [1] 329194 0
Rehabilitation
Intervention code [2] 329600 0
Behaviour
Comparator / control treatment
Strategy 1 Control: Usual GP Care delivered by their GP and informed by the COPD-X Concise Guide for Primary Care. All GPs with patients participating in the study will be provided with a copy of the latest version. In brief, this comprises confirming the COPD diagnosis and severity, optimising function, preventing deterioration, developing a care plan, managing exacerbations and, where indicated, referral to specialists and PR. The GPs will continue to see their patients as usual.

Strategy 2 Control: Usual PR, patients will not be provided with a referral to local private practice EP/PT PR by the study team. GPs and GPN/NP/AHW will be provided with the HealthPathways information about local PR options. This will be updated if necessary to ensure referral information is current.
Control group
Active

Outcomes
Primary outcome [1] 339058 0
Health status will be measured using the COPD Assessment Test (CAT) which measures the impact of COPD on a person’s life.
Timepoint [1] 339058 0
Baseline, 6 months (primary timepoint) and 12 months post-intervention commencement
Secondary outcome [1] 438421 0
The severity of a range of symptoms common to both depression and anxiety in the participant will be measured via the Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 438421 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [2] 438422 0
The participants self-rated health is will be measured through the EuroQol-5 Dimensions-5 Levels tool (EQ-5D5L)
Timepoint [2] 438422 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [3] 438423 0
The severity of dyspnea will be stratified in the Modified Medical Research Council Dyspnea scale (mMRC)
Timepoint [3] 438423 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [4] 438424 0
Health impairments, including symptoms, activity and impacts will be measured as a composite outcome through the St George’s Respiratory Questionnaire (SGRQ)
Timepoint [4] 438424 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [5] 438425 0
COPD-X care provided (including referral to PR)
Timepoint [5] 438425 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [6] 438426 0
Health service utilisation
Timepoint [6] 438426 0
Baseline, 6 months and 12 months post intervention commencement
Secondary outcome [7] 438427 0
Health service utilisation (data linkage)
Timepoint [7] 438427 0
12 months post intervention commencement
Secondary outcome [8] 438428 0
Assessment of the value of crucial elements of each strategy to individual patients and clinicians using a new survey based on Multi Criteria Decision Analysis (MCDA)
Timepoint [8] 438428 0
For participants, 6 months post intervention commencement,
For health professionals, 2-4 weeks of the last participant has completed the program.

Eligibility
Key inclusion criteria
For the PuRe Primary Care strategy, EP/PT practices will be eligible if:
i) their practice is in one of the study geographical areas,
ii) there is commitment from at least one EP/PT in the practice to be involved, and
iii) there is space and equipment suitable to provide a small group (max. 5) exercise program.
All EPs/PTs/AHAs/AHWs participating in the trial will be required to maintain a current cardiopulmonary resuscitation certificate for the duration of the study.
A research team member will meet with the interested practices and clinicians to provide information and answer questions before they provide their informed consent.
For the MDT strategy, we will identify at least three registered nurses for each of the geographical areas to work in partnership with the local GPs. These clinicians will be employed by the partner organisations and will be registered nurses including GPNs.
Patients will be eligible if they are:
i) aged 40 years and over,
ii) have a diagnosis of COPD recorded,
iii) had no exacerbations in the previous 2 weeks, and
iv) have a mobile device with Internet access for the online education program or the mPR app if they opt to use this
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if:
i) they are unable to participate in a community exercise program due to
a. serious medical condition(s) and/or
b. physical co-morbidities as identified in the screening assessment, and
ii) if they require an interpreter.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised in a de-identified manner using a central randomisation process by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be stratified by geographical location and severity as measured by the mMRC. Randomisation will be conducted using REDCap and the research assistant dedicated to this task will inform patients and clinicians of group allocation to maintain the blinding of the research team members collecting outcome data and the analysing statistician. It will not be possible to blind the patients and clinicians
Patients will be randomised after the baseline assessment using a computer-generated randomisation program, in permuted blocks of four, developed by an independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample Size:
The primary outcome measure is the CAT and the secondary outcome is uptake of PR. We will require 125 per group (power 80%, alpha less than 0.05) to detect a change in health status of 2.5 in the CAT (SD 7.2) which is greater than the minimum clinically important difference of 2. To allow for a 20% loss to follow-up at 12-months, we will recruit 150 per arm which is 600 in total. To detect a 25% increase in PR referral (power 80%, alpha less than 0.05) 80 patients per group (total 320) will be required.
In 2020/21 the rate of hospitalisations for COPD per 100,000 population was 273 for Western NSW LHD and 130 for SWSLHD which indicates relatively high levels of poorly controlled COPD in the study areas.

Qualitative Interviews
We will use qualitative descriptive methods to explore the acceptability and sustainability of the intervention from both the clinician and patient perspective. We will complete semi-structured interviews with up to 12 clinicians and 30 patients who received MDT Care or PuRe Primary Care to explore their experiences. The final number of interviews will be determined by data saturation. Semi-structured interviews with clinicians will be undertaken by the study co-ordinator when they have finished delivering their PR and MDT programs and with patients within two weeks of the 6-month follow-up assessment. Purposive sampling will be used to achieve maximum variation in key characteristics such as location, gender, ethnicity and age, and for patients, the number of comorbidities and COPD severity. Interviews will be audio-recorded and professionally transcribed using a professional transcription service. Once transcribed, the transcription will be checked against the audio file. Once checked the audio file will be deleted. All data will be stored on the University of Sydney secure research data server.

Complementing the qualitative study will be an assessment of the value of crucial elements of each strategy to individual patients and clinicians using a new survey based on MCDA. From these data, it will be possible to measure the value that individuals place on the potential costs and benefits associated with the different strategies and how they are ranked in terms of importance.

Data Analysis:
The primary outcome is COPD-related health status measured by the CAT. The mean value of the CAT total score will be compared between the four groups using independent t-tests. The change in PR referral will also be compared using independent t-tests. All tests will be two-sided. Overall, p values less than 0.05 will be considered statistically significant. Binary outcome variables will be analysed using Chi-square test and logistic regression. Transcripts of the qualitative interviews with clinicians and patients will be coded using NVivo and then analysed thematically and informed by the Theoretical Domains Framework, RE-AIM and PRISM to understand factors influencing adoption, implementation and maintenance.

Health economic analysis:
The cost-effectiveness of the new COPD strategies will be evaluated from the perspective of the health system using CAT and EQ-5D-5L. Analysis of resource use will focus on healthcare resources associated with the intervention arms including cost of training (clinician time, training materials developed and used), time costs of all healthcare professionals seen by patients during the study, laboratory costs, hospitalisations and ED presentations associated with COPD, GP visits, allied health visits (additional to the intervention), and prescribed treatments. Resource use data will be collected using a combination of questionnaires, diary cards, and data Unit costs will be obtained from published datasets: Australian-Refined Diagnosis Related Groups (ARDRG) cost weights, the Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) unit costs. Bootstrapping techniques will be used to calculate incremental cost-effectiveness ratios (ICERs) and confidence intervals. Differences in costs and health outcomes between treatment arms will be presented on the incremental cost effectiveness plane with relevant thresholds added to assess costs. Sensitivity analysis will be undertaken. Patterns in, and determinants of, healthcare utilisation, costs, and health outcomes over time will also be examined using various econometric methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317103 0
Government body
Name [1] 317103 0
Department of Health and Aged Care - Medical Research Future Fund Primary Health Care Grant (2023/MRF2032002)
Country [1] 317103 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319418 0
None
Name [1] 319418 0
Address [1] 319418 0
Country [1] 319418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315852 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315852 0
Ethics committee country [1] 315852 0
Australia
Date submitted for ethics approval [1] 315852 0
31/05/2024
Approval date [1] 315852 0
28/08/2024
Ethics approval number [1] 315852 0
2024/ETH01147

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

Contacts
Principal investigator
Name 135994 0
Prof Sarah Dennis
Address 135994 0
Level 7, Susan Wakil Health Building, University of Sydney, NSW, 2006
Country 135994 0
Australia
Phone 135994 0
+61 459898398
Fax 135994 0
Email 135994 0
[email protected]
Contact person for public queries
Name 135995 0
Jordan Kidd
Address 135995 0
Level 7, Susan Wakil Health Building, University of Sydney, NSW, 2006
Country 135995 0
Australia
Phone 135995 0
+61 423640435
Fax 135995 0
Email 135995 0
[email protected]
Contact person for scientific queries
Name 135996 0
Sarah Dennis
Address 135996 0
Level 7, Susan Wakil Health Building, University of Sydney, NSW, 2006
Country 135996 0
Australia
Phone 135996 0
+61 459898398
Fax 135996 0
Email 135996 0
[email protected]

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.