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Trial registered on ANZCTR


Registration number
ACTRN12614001155684
Ethics application status
Approved
Date submitted
8/10/2014
Date registered
31/10/2014
Date last updated
20/02/2019
Date data sharing statement initially provided
20/02/2019
Date results information initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An interdisciplinary model of care for early detection of lung damage, smoking cessation support and management of chronic obstructive pulmonary disease (COPD).
Scientific title
A cluster randomised controlled trial evaluating a novel interdisciplinary community-based intervention aimed at screening, diagnosing and managing COPD in adult long-term smokers in primary care, compared with usual care, to improve health-related quality of life.
Secondary ID [1] 285437 0
Nil
Universal Trial Number (UTN)
U1111-1159-3500
Trial acronym
RADICALS (Review of Airway Dysfunction and Interdisciplinary Community-based care in Adult Long-term Smokers)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 293196 0
Tobacco Smoking 293197 0
Condition category
Condition code
Respiratory 293471 293471 0 0
Chronic obstructive pulmonary disease
Public Health 293472 293472 0 0
Health service research
Mental Health 293624 293624 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants receiving the intervention (i.e. those in the Interdisciplinary Care Group – ICG) will be managed using Wagner’s Chronic Care Model as the guiding framework. All participants in the intervention arm will receive smoking cessation support. Participants with FEV1/FVC <0.7 (diagnosed with COPD) will receive the Lung Foundation of Australia (LFA) booklet ‘Better Living with COPD – A Patient Guide’ and will be managed according to the COPD-X Plan. The intervention will be led by a practice nurse or a research pharmacist, a consultant pharmacist (accredited to undertake medication reviews) and a physiotherapist. These staff will work in collaboration with practice GPs. Health professionals involved in the project will be offered training. ‘Supporting smoking cessation: a guide for health professionals’ and COPD-X will form the basis of all interventions.
The key components of the intervention include intensive smoking cessation support, home-based pulmonary rehabilitation and home medication review. Participants will be followed up for a total of 12 months – the components of the above intervention will be implemented (subject to patient consent) if appropriate and as required throughout this time period.

Smoking cessation support:
Intensive smoking cessation support for participants will be coordinated by the practice nurse/research pharmacist and/or consultant pharmacist. QUIT (Registered Trademark) Resources and the assistance of other staff such as GPs, nurses and dieticians will be used, where appropriate. Pharmacotherapy (over-the-counter and/or prescription) will be recommended, if appropriate. If prescription medications are required to assist smoking cessation, these will be discussed with the GP. The intervention(s) offered will be individually tailored to the patient’s needs and preferences - as such, the duration of the smoking cessation support consultation between the above mentioned study staff (practice nurse/research pharmacist and/or consultant pharmacist) and the participants will vary according to the specific needs of the individual participant. Follow up phone calls to participants will be conducted one week and one month from initial consultation (i.e. at baseline) to re-emphasise the importance of quitting and long-term abstinence, and to discuss issues surrounding relapse and relapse prevention strategies. A standard question asked in the six and 12-month follow-up questionnaire will be utilised to monitor participants’ adherence to the smoking cessation strategies recommended.

Home-based pulmonary rehabilitation:
A home-based pulmonary rehabilitation model will be employed. Key components of this model include one home visit with weekly follow-up telephone calls using a motivational interviewing approach to build confidence and set goals. Home-based pulmonary rehabilitation will be prescribed based on each patient’s exercise capacity. A goal for walking distance will be set and distance will be recorded using a pedometer. Participants will be encouraged to exercise for 30 minutes, five times per week and to record the completion of this activity in a home diary. Resistance training for the arms and legs will utilise daily activities and equipment that is readily available in the home environment (e.g. step-ups on an internal or external step, sit to stand from a standard height chair, water bottles for upper limb weights). Participants will be contacted by a physiotherapist each week by telephone for seven weeks. During the weekly telephone calls, disease specific self management training and exercise progression will be achieved using the principles of motivational interviewing. Exercise goals and health goals will be discussed and documented each week in the home diary. The duration of the home visit and weekly follow-up phone calls will vary between participants as these components are driven by and individually tailored to each participant's needs.

Home medication review:
A comprehensive home medication review from a consultant pharmacist will identify any medication-related problems and deviations from COPD-X guidelines. Recommendations regarding amendments to drug therapy will be discussed between the GP and consultant pharmacist with changes made as appropriate. The pharmacist will assess medication use of participants, including inhaler technique. Interventions for optimising medication adherence and inhaler use will be offered.
Participants who receive the home medication review will be asked to complete a questionnaire to assess satisfaction with this component of the intervention. GP feedback on each home medication review conducted will also be sought by asking them to complete a questionnaire at the time of submission of the report.
Intervention code [1] 290368 0
Early detection / Screening
Intervention code [2] 290369 0
Rehabilitation
Intervention code [3] 290476 0
Behaviour
Comparator / control treatment
Patient participants in the control arm (i.e. in the usual care group – UCG) will receive usual care and Quitline referral; those with FEV1/FVC <0.7 (diagnosed with COPD) will receive the Lung Foundation of Australia (LFA) booklet ‘Better Living with COPD – A Patient Guide’.

GP participants in the control group practices will receive a copy of the COPD-X Plan and the ‘Supporting Smoking Cessation: a guide for health professionals’.
Control group
Active

Outcomes
Primary outcome [1] 293292 0
Change in Health-related Quality of Life (HRQoL) assessed via St George’s Respiratory Questionnaire (SGRQ) in COPD patients
Timepoint [1] 293292 0
at 6 months from baseline
Secondary outcome [1] 310741 0
Exhaled CO verified 7-day point prevalence abstinence assessed using a hand-held device (Smokerlyzer Registered Trademark) in all participants
Timepoint [1] 310741 0
at 6 months from baseline
Secondary outcome [2] 310742 0
change in anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) of COPD patients
Timepoint [2] 310742 0
at 6 & 12 months from baseline
Secondary outcome [3] 310743 0
change in lung function (FEV1) via spirometry testing (using Easy on-PC Registered Trademark) in COPD patients
Timepoint [3] 310743 0
at 6 & 12 months from baseline
Secondary outcome [4] 310744 0
change in Health-related Quality of Life (HRQoL) assessed via St George’s Respiratory Questionnaire (SGRQ) in COPD patients
Timepoint [4] 310744 0
at 12 months from baseline
Secondary outcome [5] 310745 0
change in Health-related Quality of Life (HRQoL) assessed via the COPD Assessment Tool (CAT) in COPD patients
Timepoint [5] 310745 0
at 6 & 12 months from baseline
Secondary outcome [6] 311023 0
change in Health-related Quality of Life (HRQoL) assessed using the EQ-5D questionnaire in COPD patients
Timepoint [6] 311023 0
at 6 & 12 months from baseline
Secondary outcome [7] 311024 0
change in dyspnoea assessed via the Modified Medical Research Council (mMRC) Dyspnoea Scale in COPD patients
Timepoint [7] 311024 0
at 6 & 12 months from baseline
Secondary outcome [8] 311025 0
change in medication adherence as measured by the Tool for Adherence Behaviour Screening (TABS) questionnaire
Timepoint [8] 311025 0
at 6 & 12 months from baseline
Secondary outcome [9] 311026 0
change in Heaviness of Smoking Index score
Timepoint [9] 311026 0
at 6 & 12 months from baseline
Secondary outcome [10] 311027 0
change in frequency of emergency department presentations of COPD patients (patients’ self-reported number of presentations will be collected and used to assess this outcome)
Timepoint [10] 311027 0
at 6 & 12 months from baseline
Secondary outcome [11] 311028 0
change in frequency of COPD-related unplanned GP visits or hospitalisations in COPD patients (patients’ self-reported number of episodes will be collected and verified against medical records for the assessment of this outcome)
Timepoint [11] 311028 0
at 6 & 12 months from baseline
Secondary outcome [12] 311029 0
Exhaled CO verified 7-day point prevalence abstinence assessed using a hand-held device (Smokerlyzer Registered Trademark) in all participants
Timepoint [12] 311029 0
at 12 months from baseline
Secondary outcome [13] 311130 0
cost-effectiveness of RADICALS intervention by analysing changes in SGRQ score, EQ-5D and number of individuals abstaining from smoking
Timepoint [13] 311130 0
at 6 & 12 months from baseline
Secondary outcome [14] 318696 0
proportion of smokers confirmed to have COPD using spirometry
Timepoint [14] 318696 0
at baseline
Secondary outcome [15] 318697 0
patient satisfaction with home medication review assessed using a satisfaction questionnaire designed for the study
Timepoint [15] 318697 0
after completion of home medication review interview with the consultant pharmacist
Secondary outcome [16] 318698 0
GP feedback on home medication review obtained using a GP feedback questionnaire designed for the study
Timepoint [16] 318698 0
after completion of home medication review by consultant pharmacist

Eligibility
Key inclusion criteria
Current and ex-smokers of at least 10 packs years, including those with an existing diagnosis of COPD, aged 40 years or older, who had 2 or more visits to the practice in the previous 12 months. Those with an existing diagnosis of COPD but no smoking history will also be eligible.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a terminal illness (anticipated survival <12 months), those unable to provide informed consent (e.g. cognitive impairment), those with pre-existing interstitial lung disease, unstable cardiovascular status, comorbidities preventing participation in an exercise training program or contraindications to spirometry (including abdominal/thoracic/neuro-/ocular surgery in past 6 weeks, pneumothorax in past 6 weeks, haemoptysis of unknown origin, open pulmonary TB, thoracic/abdominal/cerebral aneurysms, angiogram in previous 24 hours, recent pulmonary embolus and those listed in the ATS/ERS 2005 guidelines). Those patients who have completed a pulmonary rehabilitation program in the previous 24 months will also be excluded from the study.

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)
1. Recruitment of practices and practice staff: Primary care clinics will be invited to participate in the study through advertisements and consultation with Medicare Locals/Primary Health Networks (PHNs) and key informants. Other methods of recruitment such as direct approach may be employed if necessary. Both group and solo primary care practices that have a practice nurse/pharmacist or are willing to accommodate a practice nurse / research pharmacist will be targeted.

2. Cluster Randomisation: General Practice/primary care clinics will be block randomised to control (Usual Care Group = UCG) or intervention (Interdisciplinary Care Group = ICG). Randomisation at the practice level will avoid contamination (i.e. the same practice managing patients from both control and intervention groups). A web-based randomisation program managed by an independent agency will be utilised for this allocation process.

3. Recruitment of participants: The General Practice’s clinical database will be searched to identify eligible patients, who will then be invited to participate in the study. Practice receptionists may be trained in identifying eligible patients. Other methods of recruitment such as GP referrals may be employed if necessary. Signage and pamphlets will also be used within clinics to encourage participation. Letters with an Expression of Interest (EOI) form will be sent from the practice to eligible patients formally inviting them to take part in the study. A toll-free number will also be set-up and made available for interested patients to call and obtain further information regarding the study if desired. Those interested in the study will be asked to return the completed form to the practice nurse/research pharmacist in a reply-paid envelope. Non-respondents will be sent up to two reminders at two-weekly intervals. Following receipt of the EOI, each potential participant will be contacted, inclusion/exclusion criteria applied, a meeting with the practice nurse/research pharmacist will be organised, written informed consent obtained and baseline data collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster Randomisation:

General Practice/primary care clinics will be block randomised to control (Usual Care Group = UCG) or intervention (Interdisciplinary Care Group = ICG). Randomisation at the practice level will avoid contamination (i.e. the same practice managing patients from both control and intervention groups). A web-based randomisation program managed by an independent agency will be utilised for this allocation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size:
Change in SGRQ score from enrolment is the primary efficacy end point. A difference of at least 4 points between treatment arms is considered clinically significant. Assuming a conservative standard deviation of 10 points, 99 participants per group (80% power and p < 0.05) will be required. Adjusting for clustering by practice (intra-class correlation=0.01 and cluster size 10), the required sample is 108 per arm. Allowing for attrition of 20% after enrolment, we will continue recruiting until 280 (140 in each arm) participants have entered the trial. Therefore, 28 primary care practices will be recruited and 14 each randomised to ICG and control. From each practice, 50 smokers will be screened to identify 10 with COPD (FEV1/FVC <0.7). A sample of 1400 smokers would allow the proportion of COPD patients to be estimated to be within +/-2% approximately with a 95% confidence interval from 18% - 22%. 700 smokers in each arm would allow a difference of 6% points in abstinence rates to be detected (e.g. 12% in control versus 18% in intervention) with 86% power and p < 0.05 significance level.

Statistical Analyses:
The mean change in SGRQ from enrolment in each treatment group will be estimated. Difference between groups and 95% confidence interval will be determined. Multiple linear regression analyses will be used to compare continuous outcomes between the two groups. Binary outcomes will be analysed using multiple logistic regression. All regression analyses will be adjusted for clustering, prognostic variables and potential confounders (e.g. socio-demographics, comorbidities). All primary analyses will be conducted using the intention to treat principle. Participants who are lost to follow-up will be deemed to have relapsed smoking at that point. Per protocol analysis will also be undertaken to provide a measure of reliability of the primary analyses.

Cost-effectiveness Analysis (CEA):
CEA of the study will be conducted according to the good research practices of CEA alongside clinical trials. A cost-utility analysis will also be undertaken utilising EQ-5D.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8762 0
3101 - Kew
Recruitment postcode(s) [2] 8763 0
3102 - Kew East
Recruitment postcode(s) [3] 8764 0
3103 - Balwyn
Recruitment postcode(s) [4] 8765 0
3104 - Balwyn North
Recruitment postcode(s) [5] 8766 0
3122 - Hawthorn
Recruitment postcode(s) [6] 8767 0
3123 - Hawthorn East
Recruitment postcode(s) [7] 8768 0
3124 - Camberwell
Recruitment postcode(s) [8] 8769 0
3126 - Canterbury
Recruitment postcode(s) [9] 8770 0
3146 - Glen Iris
Recruitment postcode(s) [10] 8771 0
3147 - Ashburton
Recruitment postcode(s) [11] 8772 0
3105 - Bulleen
Recruitment postcode(s) [12] 8773 0
3106 - Templestowe
Recruitment postcode(s) [13] 8774 0
3107 - Templestowe Lower
Recruitment postcode(s) [14] 8775 0
3108 - Doncaster
Recruitment postcode(s) [15] 8776 0
3109 - Doncaster East
Recruitment postcode(s) [16] 8777 0
3111 - Donvale
Recruitment postcode(s) [17] 8778 0
3113 - Warrandyte
Recruitment postcode(s) [18] 8779 0
3114 - Park Orchards
Recruitment postcode(s) [19] 8780 0
3115 - Wonga Park
Recruitment postcode(s) [20] 8781 0
3148 - Chadstone
Recruitment postcode(s) [21] 8782 0
3149 - Mount Waverley
Recruitment postcode(s) [22] 8783 0
3150 - Glen Waverley
Recruitment postcode(s) [23] 8784 0
3166 - Oakleigh East
Recruitment postcode(s) [24] 8785 0
3167 - Oakleigh South
Recruitment postcode(s) [25] 8786 0
3168 - Clayton
Recruitment postcode(s) [26] 8787 0
3170 - Mulgrave
Recruitment postcode(s) [27] 8788 0
3800 - Monash University
Recruitment postcode(s) [28] 8789 0
3125 - Burwood
Recruitment postcode(s) [29] 8790 0
3127 - Surrey Hills
Recruitment postcode(s) [30] 8791 0
3128 - Box Hill
Recruitment postcode(s) [31] 8792 0
3129 - Box Hill North
Recruitment postcode(s) [32] 8793 0
3130 - Blackburn
Recruitment postcode(s) [33] 8794 0
3131 - Forest Hill
Recruitment postcode(s) [34] 8795 0
3131 - Nunawading
Recruitment postcode(s) [35] 8796 0
3132 - Mitcham
Recruitment postcode(s) [36] 8797 0
3133 - Vermont
Recruitment postcode(s) [37] 8798 0
3151 - Burwood East

Funding & Sponsors
Funding source category [1] 290042 0
Government body
Name [1] 290042 0
National Health and Medical Research Council (NHMRC) Partnership Project grant APP1076255
Address [1] 290042 0
16 Marcus Clarke Street, Canberra City, ACT 2600

Country [1] 290042 0
Australia
Funding source category [2] 290043 0
Commercial sector/Industry
Name [2] 290043 0
Boehringer Ingelheim Pty Ltd (BI)
Address [2] 290043 0
78 Waterloo Road, North Ryde, NSW 2113
Country [2] 290043 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
381 Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 288733 0
None
Name [1] 288733 0
Address [1] 288733 0
Country [1] 288733 0
Other collaborator category [1] 278167 0
University
Name [1] 278167 0
University of New South Wales
Address [1] 278167 0
UNSW Australia, UNSW Sydney, NSW 2052
Country [1] 278167 0
Australia
Other collaborator category [2] 278168 0
University
Name [2] 278168 0
La Trobe University
Address [2] 278168 0
La Trobe Melbourne, La Trobe University, Bundoora, VIC 3086
Country [2] 278168 0
Australia
Other collaborator category [3] 278169 0
University
Name [3] 278169 0
University of Newcastle
Address [3] 278169 0
University Drive, Callaghan, NSW 2308
Country [3] 278169 0
Australia
Other collaborator category [4] 278170 0
Other
Name [4] 278170 0
Eastern Melbourne Primary Health Network (EMPHN)
Address [4] 278170 0
Corporate Office
216-218 Lower Heidelberg Road, Ivanhoe East, VIC 3079
Country [4] 278170 0
Australia
Other collaborator category [5] 278171 0
Charities/Societies/Foundations
Name [5] 278171 0
Lung Foundation Australia (LFA)
Address [5] 278171 0
Level 2, 11 Finchley Street, Milton QLD 4064
Country [5] 278171 0
Australia
Other collaborator category [6] 278172 0
Commercial sector/Industry
Name [6] 278172 0
Boehringer Ingelheim Pty Ltd (BI)
Address [6] 278172 0
78 Waterloo Road, North Ryde, NSW 2113
Country [6] 278172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291752 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 291752 0
Monash University, VIC 3800, Australia Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton
Ethics committee country [1] 291752 0
Australia
Date submitted for ethics approval [1] 291752 0
Approval date [1] 291752 0
19/05/2014
Ethics approval number [1] 291752 0
CF14/1018 – 2014000433
Ethics committee name [2] 291753 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 291753 0
Research Integrity Unit/Research Services, La Trobe University Bundoora, Victoria 3086
Ethics committee country [2] 291753 0
Australia
Date submitted for ethics approval [2] 291753 0
Approval date [2] 291753 0
12/06/2014
Ethics approval number [2] 291753 0
CF14/1018 - 2014000433

Summary
Brief summary
RADICALS is an interdisciplinary model of care that brings together the expertise of different health professional groups to provide a solution for a major public health problem, chronic obstructive pulmonary disease (COPD). This community-based model mainly surrounds interdisciplinary collaboration to deliver intensive smoking cessation support, COPD management according to COPD-X guidelines, home medication review and a home-based exercise/self-management program.
This study aims to evaluate the effectiveness and cost-effectiveness of the RADICALS program in reducing the burden of smoking and COPD through:

(a) increasing the detection of COPD among long-term smokers,
(b) improving the effectiveness of smoking cessation care provided in general practices; and
(c) improving health-related quality of life (HRQoL) of people with COPD.

It is hypothesised that:

(a) A general practice-based screening program among smokers will result in early identification of COPD
(b) Interdisciplinary care will result in higher abstinence rates at 6 months than ‘Quitline referral’ among smokers; and
(c) Among people with COPD, interdisciplinary care will maintain HRQoL better than usual care at 6 months
Trial website
Pending
Trial related presentations / publications
None
Public notes
Target sample size:
1400 smokers to give 280 participants with COPD

Recruitment postcodes:
Study participants not limited to the listed postcodes – recruitment from other postcodes may occur if required.

Contacts
Principal investigator
Name 51878 0
Dr Johnson George
Address 51878 0
Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052
Country 51878 0
Australia
Phone 51878 0
+61 3 9903 9178
Fax 51878 0
+61 3 9903 9629
Email 51878 0
Johnson.George@monash.edu
Contact person for public queries
Name 51879 0
Miss Jenifer Liang
Address 51879 0
Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052
Country 51879 0
Australia
Phone 51879 0
+61 3 9903 9178
Fax 51879 0
+61 3 9903 9629
Email 51879 0
jenifer.liang@monash.edu
Contact person for scientific queries
Name 51880 0
Dr Johnson George
Address 51880 0
Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052
Country 51880 0
Australia
Phone 51880 0
+61 3 9903 9178
Fax 51880 0
+61 3 9903 9629
Email 51880 0
Johnson.George@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1418 0
Baseline data findings:

Liang J, Abramson MJ, Zwar N, Russell G, Holland AE, Bonevski B, Mahal A, Phillips K, Eustace P, Paul E, Wilson S, George J. Diagnosing COPD and supporting smoking cessation in general practice: evidence-practice gaps. Med J Aust 2018;208(1):29-34. doi:10.5694/mja17.00664
Attachments [1] 1418 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1419 0
Conference abstract
Citation/DOI/link/details [1] 1419 0
Interim results/study progress results were submitted as conference abstracts to TSANZSRS Annual Scientific Meetings 2016 - 2019. These conference abstracts are published in Respirology.
Attachments [1] 1419 0
Results – basic reporting
Results – plain English summary