To evaluate the incremental cost-effectiveness ratio of these interventions compared to usual care by estimating the proportion of people successfully quitting tobacco use (Phase III).
Settings
The study will be conducted in health centres in the public sector which are designated TB diagnostic centres (as per WHO's definition) in rural and urban settings in two districts in Punjab, Pakistan. This has been the setting of a number of research activities carried out by the investigating team over the last 12 years mainly in tuberculosis. Diagnostic centres, in a typical district in Punjab, are generally:
● Rural health centres - rural settings
● Tehsil headquarter hospitals - urban settings
Centres are typically staffed by one to three doctors, nursing staff, laboratory technician, pharmacist and community health workers. They are also equipped with a basic microbiology laboratory capable of examining sputum for AFB. The outpatient departments are open to the population of the catchment area including referrals from Basic Health Units (a single doctor manned primary care health centre). Patients with suspected tuberculosis once seen are screened with two/three sputum examinations. If diagnosed with TB, they are registered and commenced on anti-tuberculosis therapy.
Participants and Sampling
The sampling frame will consist of all TB diagnostic health centres that are approached for this study and their doctors and other paramedical staff have expressed willingness to participate. Access to these diagnostic centres will be facilitated by one of the investigating partner organisations, ASD, which has been given the responsibility of implementing the DOTS strategy in 18 districts in Punjab. Health centres in the sampling frame will be stratified according to rural (RHC) and urban location (THQ). 11 health centres will be randomly allocated to each of the two intervention arm and the control arms, using computer generated random number lists by an independent scientist.
In each health centre, we will approach adult patients (≥18 years), who cough for 3 or more weeks and are therefore suspected and screened for pulmonary tuberculosis. We would aim to recruit at least 50 patients from each centre over a period of three to six months. Patients will be provided with both verbal and written information about the study and only those who consent will be recruited in the study.
Patients whose condition requires hospital admission or other urgent medical attention will be excluded. Patients will be approached and recruited each day.
Delivery of the intervention
We propose to use a systematic, standardised approach to deliver 'five steps to quit' to make it effective and equitable[
30]. It is envisaged that the intervention will be primary delivered by the TB DOTS facilitator based in the diagnostic centre with the help and under the supervision of the primary care doctor (Table
1). He will assess patients' eligibility for the study and send them to the TB DOTS facilitator for further assessment. All eligible patients will be provided with verbal and written information about the study and invited to participate. Patients who agree to take part will be taken through different components of the 'five steps to quit' programme in two appointments. Patients in intervention arm 1 will also be offered therapeutic option (Bupropion) and such patients will be referred to the primary care doctor for assessing suitability and prescribing Bupropion.
Table 1
Follow up and contacts with health professionals
Intervention 1 (brief psychological intervention + therapeutics) | Assess eligibility at the laboratory | TB DOTS facilitator | TB DOTS facilitator | TB DOTS facilitator | TB DOTS facilitator |
| TB DOTS facilitator | Doctor | Doctor (if necessary) | | |
| Doctor | | | | |
Intervention 2 (brief psychological intervention only) | Recruitment at the laboratory | TB DOTS facilitator | TB DOTS facilitator | | TB DOTS facilitator |
| TB DOTS facilitator | | | | |
Control (usual care + leaflet) | Recruitment at the laboratory | TB DOTS facilitator | TB DOTS facilitator | | TB DOTS facilitator |
| TB DOTS facilitator | | | | |
The TB DOTS facilitators and primary care doctors will be given a training course (using training manual) on the "five steps to quit" programme on the use of desk-guide and focusing on[
30]:
● The scientific basis of the intervention
● Techniques to enquire about the status of tobacco use
● Providing brief advice on the benefits of stopping its use through visual images
● Approaches to assess nicotine dependence and motivation to quit
● Using this motivation to propose various treatment options explaining their pros and cons
● Training in the use of available pharmacotherapies and other cognitive-behavioural strategies
● The procedure for follow-up and other technical and organisational aspects.
● Familiarity with the recording and reporting system such as revised records and new tools
Training of TB DOTS facilitators will also focus on the brief counselling techniques based on cognitive-behavioural model[
32]. A simple desk-guide will be provided with simple algorithms and instructions for health professionals to follow "five steps to quit" programme. This will also include glossy images to support patients in understanding the benefits of stopping smoking. The TB DOTS facilitator, for all eligible patients, will be responsible for:
● Assessment of the status of their tobacco use through a checklist of questions
● Advising on benefits of quitting using visual and written educational material
● Assessment of willingness for inclusion in the study and motivation to quit using a simple scoring card
● Registration and recording of demographics and contact details
● Structured counselling using a desk guide and patient planner
● Giving a quit date after a week
On the subsequent visit in a week's time, TB DOTS facilitator will be responsible for
● assessing the status of their tobacco use
● Sharing their experience of attempting to quit, listen to the difficulties they had and providing supportive counselling to help cope with the difficulties
● Referring them to doctor if the intervention arm includes therapeutic option
● Arranging follow up in a month's time.
At follow ups at week 5 and 25, TB DOTS facilitators will be responsible for
● Reassessing status of nicotine use and recording it in the tobacco use questionnaire/register
● Reviewing treatment and other options
● Rearranging follow up as per desktop guide.
In the intervention arm 1, the primary care doctors, in addition to supervising TB DOTS facilitators, will be responsible for assessing and prescribing therapeutics (Bupropion) to patients who wish to quit and are being referred by the TB DOTS facilitators. All patients on treatment will have an additional follow up visit at week 8. In intervention arm 2, doctors will be only responsible for supervising TB DOTS facilitators. They will be provided with the appropriate training and relevant materials.
Apart from the relevant training and materials, health professionals will not be provided with any other incentive, financial or otherwise. However, treatments packs will be provided from the research budget. The research officer will also organise regular supervisory visits to oversee patient management and data collection procedures. Monthly cluster meetings of the health professionals involved will also be organised to discuss progress and potential problems.
Data collection
Our pilot study will determine the feasibility of our proposed tools to gather patient details and their status of nicotine use at various appointments. The modified tools will include:
1.
'Five steps to quit" intervention cards and register
2.
A separate tobacco use questionnaire/register to record smoking status and motivation to quit
These approaches will allow us to record demographic details including gender, socio-economic status, presence of other smokers in the house and workplace, number of children at home, status of nicotine use, motivation level, type of therapy offered, extent to which therapy was used, adverse events and abstinence at different end points. We would adapt some of the tools already well described in the existing literature[
30].
Patients who are subsequently diagnosed with TB will be followed up regularly for their TB treatment and the outcomes relevant to this study will be recorded during those visits. Trial participants who are diagnosed as not having TB and being given any of the three forms of therapy will be asked to follow up at the intervals specified. Controls not diagnosed with TB and received only usual care and a leaflet will be asked to return at 4 weeks to review their respiratory condition and to assess their status of nicotine use. Attrition is a potential problem. After piloting in phase 2, patients' mobile phone numbers will also be recorded and those who are lost to follow up will be contacted via their mobile phones to assess their status of nicotine use. A high proportion of Pakistanis possess mobile phones irrespective of socio-economic status.
Similarly, at six months in both intervention and control arms, all patients who stopped tobacco use will be contacted either via their mobile phones or landlines to assess their smoking status. According to our estimate this number will approximately be at least 264.
In order to estimate the average time spent by health professionals in delivering 'five steps to quit' intervention, our research officer will spent a day at each centre to measure and record this time.
We will also record the gender and status of nicotine use among all health professionals giving advice and include a column in the above patient record tools to record which health professional delivered which element of the package.