Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN.

INTRODUCTION: Smokeless tobacco (SLT) use in low- and middle-income countries (LMICs) has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counselling session for SLT cessation in India. METHODS: We conducted an exploratory, individual parallel two group, randomised controlled trial (RCT), with baseline -and end-point (three months from randomisation) assessments in urban primary health centres in Odisha, India. A total of 250 current (i.e., users in the last three months) SLT users or dual users (i.e., smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomised to either routine care, face-to-face counselling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention. RESULTS: A total seven (77.8%) out of nine primary care centres took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomised [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomised SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at three months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages. CONCLUSIONS: This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counselling for SLT users in Indian primary care in a full randomised trial. IMPLICATIONS: This study found that combining mobile messages with face-to-face counselling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial.The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control groupThere was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users.The findings support the feasibility and acceptability of the intervention signalling the need for a larger clinical trial to test effectiveness of the intervention.

A mixed methods evaluation of the impact of ECHO® telementoring model for capacity building of community health workers in India.

INTRODUCTION: India has the largest cohort of community health workers with one million Accredited Social Health Activists (ASHAs). ASHAs play vital role in providing health education and promoting accessible health care services in the community. Despite their potential to improve the health status of people, they remain largely underutilized because of their limited knowledge and skills. Considering this gap, Extension for Community Healthcare Outcomes (ECHO)® India, in collaboration with the National Health System Resource Centre (NHSRC), implemented a 15-h (over 6 months) refresher training for ASHAs using a telementoring interface. The present study intends to assess the impact of the training program for improving the knowledge and skills of ASHA workers. METHODS: We conducted a pre-post quasi-experimental study using a convergent parallel mixed-method approach. The quantitative survey (n = 490) assessed learning competence, performance, and satisfaction of the ASHAs. In addition to the above, in-depth interviews with ASHAs (n = 12) and key informant interviews with other stakeholders (n = 9) examined the experience and practical applications of the training. Inferences from the quantitative and qualitative approaches were integrated during the reporting stage and presented using an adapted Moore's Expanded Outcomes Framework. RESULTS: There was a statistically significant improvement in learning (p = 0.038) and competence (p = 0.01) after attending the training. Participants were satisfied with the opportunity provided by the teleECHO™ sessions to upgrade their knowledge. However, internet connectivity, duration and number of participants in the sessions were identified as areas that needed improvement for future training programs. An improvement in confidence to communicate more effectively with the community was reported. Positive changes in the attitudes of ASHAs towards patient and community members were also reported after attending the training. The peer-to-peer learning through case-based discussion approach helped ensure that the training was relevant to the needs and work of the ASHAs. CONCLUSIONS: The ECHO Model ™ was found effective in improving and updating the knowledge and skills of ASHAs across different geographies in India. Efforts directed towards knowledge upgradation of ASHAs are crucial for strengthening the health system at the community level. The findings of this study can be used to guide future training programs. Trial registration The study has been registered at the Clinical Trials Registry, India (CTRI/2021/10/037189) dated 08/10/2021.

Validation of Mobile Messages for an mHealth Intervention for Smokeless Tobacco Cessation in India.

BACKGROUND: With the growth in use of mobile messages for behaviour change, the need to incorporate personal needs and cultural characteristics of target users has been promoted. The study aimed to describe the findings of content validation of mobile messages designed to promote smokeless tobacco cessation in primary care. METHODS: This study used a concurrent mixed-method approach with 13 patients who were tobacco users at urban primary care clinics. The clarity and appeal of 32 messages were rated on a Likert scale from 1 to 10. A mean clarity and appeal score per message was generated. A 5-item discussion guide was used for in-depth interviews and data was analysed using framework analysis. RESULTS: Participants found the content of the messages useful, and preferred shorter and audio formatted messages. The clarity scores for the messages ranged from 7.9 to 9.4 with an average score of 8.7 (SD 0.5). The appeal scores ranged from 7.3 to 9.2, with an average score of 8.5 (SD 0.6). CONCLUSIONS: Twenty-six from a total of 32 messages were found appropriate and finalised for use. This methodology can be used when developing contextually relevant mobile message interventions in other low resource settings.

Designing a mobile health smokeless tobacco cessation intervention in Odisha, India: User and provider perspectives.

Objective: There is limited evidence on the development of mobile health (mHealth) interventions for smokeless tobacco (SLT) cessation, despite its widespread use in South Asia. This formative qualitative study explored the perceptions of tobacco users and healthcare providers (HCPs) regarding developing a mHealth intervention for SLT cessation. Methods: This was a qualitative study using in-depth interviews (IDIs) with tobacco users (n = 26) and primary care physicians (PCPs) (n = 5) and focus group discussions (FGDs) with counsellors (n = 2) in four urban primary health centres (UPHCs) in Berhampur, Odisha from February to March 2020. The data were coded and analysed by two researchers using a framework analysis method. The discussion guides and initial codes were developed based on the Transtheoretical Model (TTM) of behaviour change. Results: The results were elaborated under four themes: (1) Current scenario of SLT use; (2) Barriers and facilitators for quitting SLT; (3) Barriers and facilitators for mHealth counselling; and (4) Design and delivery of the proposed intervention. SLT use was prevalent in the community regardless of sociodemographic factors. Peer factors accounted for both tobacco consumption as well as considering cessation. Participants considered mobile message counselling helpful and acceptable. Not having a mobile phone and illiteracy were identified as barriers while ease of access and rising popularity of social media applications were considered facilitators to the use of mHealth for quitting tobacco. Participants preferred messages that were pictorial, short and simple, in the local language, and tailored to individual's needs. Conclusions: This is the first study that provides evidence within the Indian context that the text messaging platform may be used for delivering an SLT cessation intervention. The integration of a theoretical basis and research findings from target users can guide future intervention development.

Evaluation of COVID-19 ECHO training program for healthcare workers in India - A Mixed-Method Study.

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) has severely challenged healthcare delivery systems worldwide. Healthcare Workers were unable to assess and manage the cases due to limited knowledge of treating the virus and inadequate infrastructure. Digital interventions played a crucial role in the training of healthcare workers to get through the pandemic. Project Extension for Community Healthcare Outcomes (ECHO) initiated the COVID-ECHO telementoring program for strengthening the knowledge and skills of healthcare workers. The study aimed at assessing the effects of the ECHO telementoring model in the capacity building of healthcare workers in the context of COVID-19 in India. METHOD: We adopted a mixed-method approach with a parallel combination design. A quantitative survey was used to measure changes in the knowledge and self-efficacy among doctors and nurses. In-depth Interviews were used for qualitative exploration of perceptions and experiences of all the study participants. Student t-test and ANOVA were used to assess significant differences between mean scores across participant characteristics for different themes. Statistical significance was set at p < 0.05. In-depth Interviews were analyzed using Framework Analysis. The evaluation followed the first five levels of Moore's model. RESULTS: The results highlighted the strengthening of knowledge and skills of healthcare workers in the assessment and management of COVID-19 after the ECHO training. Learning and performance ratings were high as 96% reported an increase in knowledge and 98% were able to apply it in their clinical practices. The key challenges identified were technical issues like internet connectivity and lack of interaction due to limited visual connection. The hybrid sessions, use of video camera, feedback mechanism, and inclusion of Continuing Medical Education were recommended by participants to improve the model. CONCLUSIONS: The findings of this study are an important addition to the pre-existing literature supporting the replicability of the ECHO model in the upskilling of healthcare professionals working in underserved and remote areas, not only in the context of COVID-19 but also in other public health domains. To enhance the effectiveness of this ECHO model, the study findings may be used to refine the model and improve the areas of concern.

Patient Satisfaction with Quality of Primary Care Health services-findings from India.

BACKGROUND: Patient satisfaction is an essential indicator for measuring the quality of care. This study assessed patients' satisfaction with primary care services across different public health care system levels. METHODS: The study was a cross-sectional study conducted across three states in India. We adopted a multi-stage stratified random sampling technique to select the districts(n-13) and facilities (n-55). A total of 4650 patients' exit interviews were conducted. Linear regression and analysis of variance was used to test the association. Analyses was performed using Stata software (version 15.0). RESULTS: Patients visiting the primary facilities were more satisfied within the different domains of quality indicators that is, technical, communication, safety and cleanliness, and cost of services. The highest differences were observed on behaviour of other staff (Reg Coefficient 4.1 ± 0.8) and cleanliness of the ward (Reg Coefficient 4.0 ± 0.9). Significant negative association was observed in patient's satisfaction in the state of Kerala with an increase in age and education level. CONCLUSION: Our study suggests higher satisfaction at primary care facilities as compared to secondary and tertiary level facilities in the three states. Development of standardized tool and specific research on patient experience and its relation to the quality of care is needed in low- and middle-income countries.

Exploratory randomised trial of face-to-face and mobile phone counselling against usual care for tobacco cessation in Indian primary care: a randomised controlled trial protocol for project CERTAIN.

INTRODUCTION: Despite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise that mobile phone counselling will be feasible and effective for smokeless tobacco cessation intervention in India. This paper presents the protocol of the development and conduct of an exploratory trial before progression to a full randomised controlled trial. METHODS AND ANALYSIS: An exploratory randomised controlled trial will be conducted in urban primary health centres in the state of Odisha, India. A total of 250 smokeless tobacco users will be recruited to the study (125 in each arm). Participants in the intervention arm will receive routine care together with a face-to-face counselling intervention followed by advice and reminder mobile messages. The control arm will receive routine care, delivered by a primary care physician based on 'Ask' and 'Advice'. All participants will be followed up for 3 months from the first counselling session. The primary outcome of this trial is to assess the feasibility to carry out a full randomised controlled trial. ETHICS AND DISSEMINATION: Ethical approvals were obtained from the Institutional Ethics Committee of Public Health Foundation of India, Health Ministry's Screening Committee, Odisha State Ethics Board and also from University College London Research Ethics Committee, UK. The study findings will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: CTRI/2019/05/019484.