Exploratory randomised trial of face to face and mobile phone counselling against usual care for tobacco cessation in Indian primary care

Smoked and smokeless tobacco use is a major cause of heart disease, cancer and lung diseases and it is one of the leading cause of ill health and death in India. Services that promote stopping the use of tobacco is best delivered best in Indian primary health care since it is the first point of public access to the health care system. Over a third of people attending primary care in Rajasthan use smoked or smokeless tobacco and the cost to the state of Rajasthan (where this development work will be conducted) attributed to this behaviour is estimated at 1160 crores (i.e. £1.3 billion) rupees. There is hence an urgent need to improve the evidence to reduce the use of tobacco amongst people seen in Indian primary care. The evidence from high income countries suggest that treatments delivered by health professionals, counsellor and through the mobile phones can be effective. The co-PI in the UK (Irwin Nazareth) has already worked on two major RCTs on smoking cessation in UK primary care and the co-PI in India (Rajmohan Panda) has developed tobacco cessation interventions in India that use online and face to face interventions for delivery in primary care clinics. Some of his early work suggests that Indian primary care physicians do not have the time to offer tobacco cessation counselling session and hence this should be delivered by dedicated counsellors as is done in the UK. Mobile phone interventions are widely used for healthcare in the developed world and research in the field of smoking cessation suggest that they can increase the chance of quitting tobacco by 25-50%. Even though the WHO has advocated the use of such interventions in low and middle income countries (LMIC), to date there have been no evaluations of its effectiveness. There is hence, an urgent need to test the use of mobile phone call and messages for tobacco cessation in Indian primary care.

Our overarching aim is to conduct a randomised trial designed to evaluate the effectiveness as measured by tobacco cessation and overall cost value of a face-to-face counselling intervention coupled with a mobile phone call and messaging intervention delivered to smoking and smokeless tobacco users visiting Indian primary care clinics in addition to routine care provided by the primary care professional. In order to do this we need to do early development work that finalises the intervention and tests whether it is acceptable and feasible to test it in a small randomised trial.

In this development grant we will initially finalise the development of the two components of a complex intervention which are a single 10 minute face to face counselling session delivered by a tobacco cessation counsellor and a mobile phone intervention that offers regular calls and messages every three weeks over six month. The first component has already been developed by the Indian co-PI (RP) and the mobile phone component will be developed as a part of this study. The details of how these treatments are delivered within the trial will be written into a study manual that will be used by the professionals involved. This will then lead to the testing of the intervention within a small feasibility trial in which people will be randomly given either the intervention or usual care. We will assess how many tobacco users in the study centres who are asked to take part in the study agree to be randomised. We will also assess how many of them will then agree to be followed up at six months so as to allow us to assess the outcome of these treatments. We will recruit 250 users from 10 primary care clinics in the state of Rajasthan, India. Successful development of the intervention, adequate recruitment to the trial and follow up at six months will be the main success measures of this development grant. This will then allow us to apply to the MRC and any other relevant funders for the next stage of this research which will be the conduct of a full randomised trial.

Smoked and smokeless tobacco use is a major cause of cardiovascular disease, cancer and COPD and is one of the leading causes of morbidity and mortality in India. About, 35-50% of Indian primary care attenders are tobacco users. Evidence from the developed world suggest that interventions delivered by health professionals and counsellor are effective. Mobile phone interventions used for smoking cessation can increase the chance of quitting tobacco by 25-50%. There is an urgent need to assess the effectiveness of these interventions in Indian primary care.

Our eventual plan is to conduct a RCT designed to evaluate the clinical and cost effectiveness of a complex intervention of a face-to-face counselling intervention coupled with a mobile phone call and messaging intervention delivered to smoking and smokeless tobacco users visiting Indian primary care clinics in addition to routine care. In order to do this we need to do conduct early development work that finalises the detail of the intervention and test the acceptability and feasibility of its evaluation in an exploratory randomised trial. We will in this development grant finalise the two components of the intervention, a single 10 minute counselling session delivered by a cessation advisor and a mobile phone intervention offering regular calls and messages every three weeks over six month. The first component has been developed and the mobile phone component will be developed as a part of this study. The intervention will then be tested in a randomised trial designed to assess the feasibility of recruitment and the follow up of tobacco users to the study. We will recruit 250 users from 10 primary care clinics in the state of Rajasthan, India. Successful development of the intervention, adequate recruitment to the trial and follow up at six months will be the main success of this development grant. This will facilitate the next stage of this research, the conduct of a full randomised trial.

Even though the key target audience of this research will be service providers working in primary care and patients who are tobacco users visiting primary health care facilities, this work will also impact on other stakeholders as listed below:

1) The health care providers will benefit from the proposed research through an improved understanding of the low-cost intervention models for tobacco cessation which can be integrated in primary care. The delivery of comprehensive, person-focused primary care behavioral interventions and mobile phone health technology will provide pathways for understanding low-cost long term prevention intervention in tobacco cessation and non-communicable diseases (NCDs).
2) The second group to benefit from this work will be researchers and academics planning similar studies in India as well as in other developing countries. The evidence generated from this study will provide insights to researchers for designing similar studies and appropriate interventions in Tobacco Cessation and NCDs. Since there is little research in this area in LMIC, this work will provide an impetus for researchers working in the area of Tobacco Cessation to generate new studies. They will be in a position to adapt the methodologies employed by us and utilise the tools developed and piloted in this study. Engagement with researchers and academics will occur through standard academic channels in addition to some non-standard methods. This will be done through personal interactions as well as scheduled dissemination meetings. The study methodology and the study results will be published in peer-reviewed journals. Press-releases will provide further exposure through the scientific news media. The results of the proposed research will be made available for open access download from the PHFI's website.
3) This study will also strengthen the capacity of PHFI researchers in designing and implementing complex randomised control trials in primary care. This project will also foster stronger collaborations with leading research and training institutes in the UK namely the University College London PRIMENT Clinical Trial Unit and PHFI. The PRIMENT UK mission is to conduct high quality randomised control trials in primary care. We believe the findings of this grant will promote this mission to conduct larger multi-centric trials across geographical boundaries. PHFI and University College London have strong links with health advisors in numerous international developmental and research agencies. Members of the research team will work on these links to advocate the findings of the trials for more resources to fund complex trials in primary care.
4) The research team has already engaged with the government in Rajasthan on this research to ensure that it will be nested within ongoing efforts made by the government to improve health system response to Tobacco Control and NCDs. The research emerging from the final trial has the potential to influence health outcomes and will hence inform health planners on the service delivery of tobacco cessation interventions. Policy briefs emanating from such future work will be circulated to the various State Ministries of Health and Family Welfare and through PHFI's wide network of contacts in India. The outputs from future research can hence have a substantial impact on government policy in the long term.