ANZCTR - Registration

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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]

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)

Tobacco Smoking

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Public Health

Health service research

Mental Health

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]

Early detection / Screening

Intervention code [2]

Rehabilitation

Intervention code [3]

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]

Change in Health-related Quality of Life (HRQoL) assessed via St George’s Respiratory Questionnaire (SGRQ) in COPD patients

Timepoint [1]

at 6 months from baseline

Secondary outcome [1]

Exhaled CO verified 7-day point prevalence abstinence assessed using a hand-held device (Smokerlyzer Registered Trademark) in all participants

Timepoint [1]

at 6 months from baseline

Secondary outcome [2]

change in anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) of COPD patients

Timepoint [2]

at 6 & 12 months from baseline

Secondary outcome [3]

change in lung function (FEV1) via spirometry testing (using Easy on-PC Registered Trademark) in COPD patients

Timepoint [3]

at 6 & 12 months from baseline

Secondary outcome [4]

change in Health-related Quality of Life (HRQoL) assessed via St George’s Respiratory Questionnaire (SGRQ) in COPD patients

Timepoint [4]

at 12 months from baseline

Secondary outcome [5]

change in Health-related Quality of Life (HRQoL) assessed via the COPD Assessment Tool (CAT) in COPD patients

Timepoint [5]

at 6 & 12 months from baseline

Secondary outcome [6]

change in Health-related Quality of Life (HRQoL) assessed using the EQ-5D questionnaire in COPD patients

Timepoint [6]

at 6 & 12 months from baseline

Secondary outcome [7]

change in dyspnoea assessed via the Modified Medical Research Council (mMRC) Dyspnoea Scale in COPD patients

Timepoint [7]

at 6 & 12 months from baseline

Secondary outcome [8]

change in medication adherence as measured by the Tool for Adherence Behaviour Screening (TABS) questionnaire

Timepoint [8]

at 6 & 12 months from baseline

Secondary outcome [9]

change in Heaviness of Smoking Index score

Timepoint [9]

at 6 & 12 months from baseline

Secondary outcome [10]

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]

at 6 & 12 months from baseline

Secondary outcome [11]

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]

at 6 & 12 months from baseline

Secondary outcome [12]

Exhaled CO verified 7-day point prevalence abstinence assessed using a hand-held device (Smokerlyzer Registered Trademark) in all participants

Timepoint [12]

at 12 months from baseline

Secondary outcome [13]

cost-effectiveness of RADICALS intervention by analysing changes in SGRQ score, EQ-5D and number of individuals abstaining from smoking

Timepoint [13]

at 6 & 12 months from baseline

Secondary outcome [14]

proportion of smokers confirmed to have COPD using spirometry

Timepoint [14]

at baseline

Secondary outcome [15]

patient satisfaction with home medication review assessed using a satisfaction questionnaire designed for the study

Timepoint [15]

after completion of home medication review interview with the consultant pharmacist

Secondary outcome [16]

GP feedback on home medication review obtained using a GP feedback questionnaire designed for the study

Timepoint [16]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/11/2014

Actual

5/03/2015

Date of last participant enrolment

Anticipated

Actual

5/04/2017

Date of last data collection

Anticipated

30/04/2018

Actual

22/01/2018

Sample size

Target

280

Accrual to date

Final

272

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3101 - Kew

Recruitment postcode(s) [2]

3102 - Kew East

Recruitment postcode(s) [3]

3103 - Balwyn

Recruitment postcode(s) [4]

3104 - Balwyn North

Recruitment postcode(s) [5]

3122 - Hawthorn

Recruitment postcode(s) [6]

3123 - Hawthorn East

Recruitment postcode(s) [7]

3124 - Camberwell

Recruitment postcode(s) [8]

3126 - Canterbury

Recruitment postcode(s) [9]

3146 - Glen Iris

Recruitment postcode(s) [10]

3147 - Ashburton

Recruitment postcode(s) [11]

3105 - Bulleen

Recruitment postcode(s) [12]

3106 - Templestowe

Recruitment postcode(s) [13]

3107 - Templestowe Lower

Recruitment postcode(s) [14]

3108 - Doncaster

Recruitment postcode(s) [15]

3109 - Doncaster East

Recruitment postcode(s) [16]

3111 - Donvale

Recruitment postcode(s) [17]

3113 - Warrandyte

Recruitment postcode(s) [18]

3114 - Park Orchards

Recruitment postcode(s) [19]

3115 - Wonga Park

Recruitment postcode(s) [20]

3148 - Chadstone

Recruitment postcode(s) [21]

3149 - Mount Waverley

Recruitment postcode(s) [22]

3150 - Glen Waverley

Recruitment postcode(s) [23]

3166 - Oakleigh East

Recruitment postcode(s) [24]

3167 - Oakleigh South

Recruitment postcode(s) [25]

3168 - Clayton

Recruitment postcode(s) [26]

3170 - Mulgrave

Recruitment postcode(s) [27]

3800 - Monash University

Recruitment postcode(s) [28]

3125 - Burwood

Recruitment postcode(s) [29]

3127 - Surrey Hills

Recruitment postcode(s) [30]

3128 - Box Hill

Recruitment postcode(s) [31]

3129 - Box Hill North

Recruitment postcode(s) [32]

3130 - Blackburn

Recruitment postcode(s) [33]

3131 - Forest Hill

Recruitment postcode(s) [34]

3131 - Nunawading

Recruitment postcode(s) [35]

3132 - Mitcham

Recruitment postcode(s) [36]

3133 - Vermont

Recruitment postcode(s) [37]

3151 - Burwood East

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Partnership Project grant APP1076255

Address [1]

16 Marcus Clarke Street, Canberra City, ACT 2600

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Boehringer Ingelheim Pty Ltd (BI)

Address [2]

78 Waterloo Road, North Ryde, NSW 2113

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of New South Wales

Address [1]

UNSW Australia, UNSW Sydney, NSW 2052

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

La Trobe University

Address [2]

La Trobe Melbourne, La Trobe University, Bundoora, VIC 3086

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

University of Newcastle

Address [3]

University Drive, Callaghan, NSW 2308

Country [3]

Australia

Other collaborator category [4]

Other

Name [4]

Eastern Melbourne Primary Health Network (EMPHN)

Address [4]

Corporate Office
216-218 Lower Heidelberg Road, Ivanhoe East, VIC 3079

Country [4]

Australia

Other collaborator category [5]

Charities/Societies/Foundations

Name [5]

Lung Foundation Australia (LFA)

Address [5]

Level 2, 11 Finchley Street, Milton QLD 4064

Country [5]

Australia

Other collaborator category [6]

Commercial sector/Industry

Name [6]

Boehringer Ingelheim Pty Ltd (BI)

Address [6]

78 Waterloo Road, North Ryde, NSW 2113

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

Monash University, VIC 3800, Australia Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/05/2014

Ethics approval number [1]

CF14/1018 – 2014000433

Ethics committee name [2]

La Trobe University Human Ethics Committee

Ethics committee address [2]

Research Integrity Unit/Research Services, La Trobe University Bundoora, Victoria 3086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/06/2014

Ethics approval number [2]

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

Dr Johnson George

Address

Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052

Country

Australia

Phone

+61 3 9903 9178

Fax

+61 3 9903 9629

[email protected]

Contact person for public queries

Name

Miss Jenifer Liang

Address

Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052

Country

Australia

Phone

+61 3 9903 9178

Fax

+61 3 9903 9629

[email protected]

Contact person for scientific queries

Name

Dr Johnson George

Address

Centre for Medicine Use and Safety,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade, Parkville
VIC 3052

Country

Australia

Phone

+61 3 9903 9178

Fax

+61 3 9903 9629

[email protected]

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Baseline data findings: Liang J, Abramson MJ, Z... [More Details]
Conference abstract	No		Interim results/study progress results were submit... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Diagnosing COPD and supporting smoking cessation in general practice: Evidenceepractice gaps.	2018	https://dx.doi.org/10.5694/mja17.00664
Embase	Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: Study protocol for a cluster randomised controlled trial.	2017	https://dx.doi.org/10.1136/bmjopen-2017-016985
Embase	Interdisciplinary COPD intervention in primary care: A cluster randomised controlled trial.	2019	https://dx.doi.org/10.1183/13993003.01530-2018
Dimensions AI	A smoking cessation intervention in Australian General Practice: secondary analysis of a cluster randomised controlled trial	2021	https://doi.org/10.3399/bjgp.2020.0906

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically