None listed
Conditions
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
Interventions
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
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed