Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication. METHODS: The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done. DISCUSSION: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment. TRIAL REGISTRATION: The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

Development and effect of a coordinated Community Health Worker (CHW) Intervention (C-CHW-I) model for the stroke survivors in Kerala, South India.

INTRODUCTION: Structured models for secondary prevention of stroke in community settings are scarce. We aimed to develop and evaluate a model for improving medication adherence and enhanced risk factor monitoring. METHODS: We developed a multimodal C-CHW-I model for stroke survivors. Following training, all patients received a minimum of three CHW home visits, and once in 3-month telephone-call and health education for six months by CHWs. Seven blocks from 16 blocks of the study area were randomised to additionally receive an SMS alert for six months to reinforce CHW involvement. The primary outcomes were medication adherence and risk factor monitoring, and the secondary outcome was risk factor control. RESULTS: The mean age of the study population was 64+12 years, 765(85%) had ischaemic stroke. In the overall study cohort receiving the CHW intervention, mean medication adherence significantly improved from 3.56(0.88) at baseline to 3.78(0.61) at 6 months; p<0.001. Overall risk factor monitoring improved from 42.7% to 49.7%, and mean (standard deviation) systolic blood pressure (SBP) significantly reduced from 138(21) mmHg to 132(15) mmHg at 6-months; p<0.001. In patients additionally receiving SMS-based intervention, a statistically significant improvement in medication adherence was seen at 3 months (3.76+0.64 versus 3.61+0.81; p=0.008) however no difference persisted at 6 months. The proportion of smokers and alcohol users reduced in both groups with a trend to greater reduction in the intervention group (smokers:5.9% versus 2.8% (p=0.446) and alcohol users: 1.6% versus 1.4%(p=0.474)). At six months, the SBP did not differ (SBP (132.1(16.2) in the SMS group versus 133.2(15.8) mmHg in the control group, p=0.409). CONCLUSION: Our model improved medication adherence and risk factor monitoring of stroke survivors in community settings, and this can reduce stroke burden in the community.

Stroke awareness among community health workers from rural health blocks of Thiruvananthapuram, India.

Objectives: Secondary prevention of stroke largely depends on risk factor control and lifestyle modification. Optimal secondary prevention strategies are limited in rural settings due to the shortage of primary care physicians and neurologists. Awareness of community health workers (CHWs) regarding stroke and its management remains largely unexplored. The current cross-sectional study aimed at assessing the knowledge, attitude, and practice (KAP) of CHWs regarding stroke care. Materials and Methods: A structured KAP questionnaire was administered among 510 CHWs from randomly selected rural health blocks of Thiruvananthapuram, Kerala, India. Results: Knowledge assessment showed that the CHWs possessed an average knowledge of stroke care. The mean attitude and practice scores were higher, indicating a favorable attitude and good practice. The overall mean (standard deviation) KAP scores of CHWs were 13.54 (4.43) against a total score of 23. The KAP scores were highest among palliative care nurses. The stroke awareness of the accredited social health activists was comparatively lower than other CHWs. Factors such as age and years of work experience were not correlated to the KAP scores. Conclusion: Recurrent strokes remain a major challenge in primary care. Overall, the health workers demonstrated average knowledge, favorable attitudes, and positive practices. The study highlights the importance of training accredited social health activists (ASHAs) and other CHWs in stroke to improve secondary prevention strategies.

Compliance with Medication amongst Persons with Diabetes Mellitus during the COVID-19 Pandemic, Kerala, India: A Cross Sectional Study.

Compliance with medication in persons with diabetes mellitus (DM) has been a challenge during the COVID-19 pandemic, leading to poor glycemic control and higher risk of complications. In the state of Kerala, India, 20−25% of adults have DM. Our cross-sectional study aimed to assess medication compliance and factors associated with poor compliance in DM persons attending selected primary care government facilities in Kerala during the COVID-19 pandemic. Persons registered with DM for >6 months were consecutively interviewed between August and September 2021. Poor compliance was defined as answering "No" to one or more of three questions related to access and intake of medication two weeks prior to and the day before the interview. Factors independently associated with poor compliance were assessed using adjusted prevalence ratios (aPr) and 95% confidence intervals. Of the 560 DM persons included, 209 (37%) exhibited poor compliance. Factors associated with poor compliance were age 19−45 years (aPr 1.4, 1.1−1.9); inability to be blood glucose tested during the COVID-19 pandemic (aPr 3.6, 2.9−4.3); not having COVID-19 (aPr 1.4, 1.0−1.9); and being double vaccinated against COVID-19 (aPr 1.4, 1.1−2.0). Focused attention must be paid to these groups to improve medication compliance and prevent DM complications and severe COVID-19-related disease.

Design and Process of Implementation Mobile Application Based Modular Training on Early Detection of Cancers (M-OncoEd) for Primary Care Physicians in India.

BACKGROUND: Early detection of curable cancers is a cost-effective way to address the cancer care burden of low- and middle-income countries and active engagement of primary care physicians using mobile technology can have a significant impact on cancer outcomes in a short time. AIMS: To describe the process of mHealth study; Oncology Education and Training for Providers using Mobile Phones which developed a mobile application (M-OncoEd) to educate physicians on approaches to early detection of curable cancers. It also aims to describe how the insight gained through qualitative research by the researchers was used in the design and implementation of the project. METHODOLOGY: Qualitative research methods were used in all the phases of the study. Phenomenology was used in the formative phase with three expert meetings, two Focus Group Discussion (FGD) and five In-depth Interviews (IDI), and during the implementation stage with two FGDs, three IDI, and five informal discussions. OBSERVATIONS: The majority of curable cancers are detected at a late stage and poorly managed in India, and active engagement of primary care physicians can have a significant impact on cancer outcomes. There is a lack of knowledge and skills for early detection of cancers among consultants and physicians and this can be attributed to the training gap. M-OncoEd was a need-based well designed engaging learning platform to educate primary care physicians on Breast, Cervical, and Oral Cancer early detection. It was found to be very useful by the beneficiaries and made them more confident for early detection of cancers from the community. CONCLUSIONS: This research study could design a need-based, cost-effective mobile-based learning tool for primary care physicians using the expertise and experience of the experts in cancer care using qualitative methods.

Provision of the Continuum of Care to Noncommunicable Diseases Post-Floods in Kerala, India 2018.

Integrating noncommunicable disease (NCD) in health care delivery during emergency response posed a major challenge post-floods in Kerala. Kerala experienced an abnormally high rainfall during mid-2018 where more than 400 people lost their lives. State health officials and the Disaster Response Team were sensitized about the importance of including NCDs in the response action. More than 80% of patients with hypertension and diabetes were not under control in Kerala. Under the state NCD cell, an NCD expert group was consulted for drafting the treatment and referral strategies. Steps to tackle NCDs during the disaster response were formulated. The state NCD cell decided to integrate NCDs in the response measures. The technical guidance document by the World Health Organization South-East Asia Region was consulted to formulate actions. The activities were implemented in 6 steps: prioritizing of major NCDS, patient estimation and drug stock preparation, standard treatment protocol, mapping of referral facilities, public engagement, and daily reporting of NCD consultations. Prioritizing the continuum of care of NCDs during floods among the program managers and care providers was crucial. The health education and communication campaign was done to sensitize the known NCD patients to seek early care. Daily reporting of consultations was established.

Interventions to Ensure the Continuum of Care for Hypertension During the COVID-19 Pandemic in Five Indian States-India Hypertension Control Initiative.

Background: Hypertension is the leading risk factor for cardiovascular disease in India, but less than 10% of the estimated people with hypertension have blood pressure under control. The India Hypertension Control Initiative (IHCI) was implemented to strengthen hypertension management and control in public sector health facilities. Since late March 2020, lockdown due to the COVID-19 pandemic limited healthcare access and disrupted the provision of essential health services. IHCI quickly implemented adaptive interventions to improve access to medications. Objectives: To estimate the availability of antihypertensive drugs in peripheral public sector facilities during the lockdown and the proportion of patients who received drugs through community drug distribution, i.e., through Health and Wellness Centers (HWCs)/Sub-Centers (SCs), the most peripheral public sector health facilities for primary care, and home delivery. Methods: We collected data from 29 IHCI districts of 5 states (Kerala, Madhya Pradesh, Maharashtra, Punjab, and Telangana) during April-May 2020. The population included individuals diagnosed with hypertension and enrolled under IHCI in all public sector primary care health facilities. We contacted a convenience sample of more than one-third of the functional HWC/SC and analyzed the proportion of facilities and patients who received drugs. We also contacted a convenience sample of patients telephonically to estimate their self-reported availability of drugs. Conclusion: Of the 4245 HWC/SC, more than one-third were contacted telephonically, and 85-88% had received antihypertensive medications for community-level distribution. Among 721,675 patients registered until March 2020, 38.4% had received drug refills through HWC/SC or home delivery by frontline workers during the lockdown. We demonstrated the feasibility of community-level drug distribution for patients with hypertension during the COVID-19 lockdown in India. The adaptive strategy of community-based drug distribution through HWC/SC and home delivery appears feasible and may help improve access to hypertension care during the COVID-19 pandemic and beyond.

Burden of Diabetic Retinopathy amongst People with Diabetes Attending Primary Care in Kerala: Nayanamritham Project.

BACKGROUND: The burden of diabetic retinopathy (DR) in people attending the public health sector in India is unclear. Thirty percent of the population in India is reliant on public healthcare. This study aimed to estimate the prevalence of DR and its risk factors in people with diabetes in the non-communicable disease registers who were attending the family health centres (FHCs) in the Thiruvananthapuram district in Kerala. METHODS: This cross-sectional study was conducted over 12 months in 2019 within the framework of a pilot district-wide teleophthalmology DR screening programme. The age- and gender-adjusted prevalence of any DR and sight-threatening DR (STDR) in the whole sample, considering socio-demography, lifestyle and known clinical risk groups, are reported. RESULTS: A total of 4527 out of 5307 (85.3%) screened in the FHCs had gradable retinal images in at least one eye. The age and gender standardised prevalence for any DR was 17.4% (95% CI 15.1, 19.7), and STDR was 3.3% (95% CI 2.1, 4.5). Ages 41-70 years, males, longer diabetes duration, hyperglycaemia and hypertension, insulin users and lower socio-economic status were associated with both DR outcomes. CONCLUSIONS: The burden of DR and its risk factors in this study highlights the need to implement DR screening programs within primary care to reduce health inequality.

Acceptability, Utility, and Cost of a Mobile Health Cancer Screening Education Application for Training Primary Care Physicians in India.

PURPOSE: Mobile health (mHealth)-based oncology education can be a powerful tool for providing cancer screening knowledge to physicians, as mobile technology is widely available and inexpensive. We developed a mobile application (M-OncoED) to educate physicians on cancer screening and tested the acceptability, utility, and cost of two different approaches to recruit physicians. METHODS: M-OncoED was designed to perform pre- and postlearning assessments through the in-built quizzes; present case studies and educational materials for cervical, breast, and oral cancer screening; collect responses to interactive queries; document module completion; send reminders and alerts; and track user metrics, including number of sessions to complete each module and time spent per session. We tested two recruitment approaches: a broad-scale recruitment group, for which we relied on e-mails, messaging apps (e.g., WhatsApp), and phone calls, and the targeted recruitment group, for which we conducted a face-to-face meeting for the initial invitation. RESULTS: Overall, about 35% of those invited in the targeted group completed the course compared with about 3% in the broad-based recruitment group. The targeted recruitment approach was more cost-efficient ($55.33 vs. $109.43 per person). Cervical cancer screening knowledge increased by about 30 percentage points, and breast cancer screening knowledge increased by 10 percentage points. There was no change in knowledge for oral cancer scorings. CONCLUSION: This study has demonstrated the feasibility and utility of using an mHealth app to educate physicians. A more intensive hands-on recruitment approach is likely required to engage physicians to download and complete the app. Future studies should assess the impact of mHealth tools on physician behavior and patient outcomes. IMPLICATIONS FOR PRACTICE: Mobile health (mHealth)-based oncology education can be a powerful tool for providing cancer screening knowledge to physicians, as mobile technology is widely available and inexpensive. This study has demonstrated the feasibility and utility of using an mHealth app to educate physicians and illustrates the type of recruitment approach (face-to-face) that is likely required to incentivize physicians to download the app and complete the training.

Complex interventions to implement a diabetic retinopathy care pathway in the public health system in Kerala: the Nayanamritham study protocol.

INTRODUCTION: Using a type 2 hybrid effectiveness-implementation design, we aim to pilot a diabetic retinopathy (DR) care pathway in the public health system in Kerala to understand how it can be scaled up to and sustained in the whole state. METHODS AND ANALYSIS: Currently, there is no systematic DR screening programme in Kerala. Our intervention is a teleophthalmology pathway for people with diabetes in the non-communicable disease registers in 16 family health centres. The planned implementation strategy of the pathway will be developed based on the discrete Expert Recommendations for Implementing Change taxonomy. We will use both quantitative data from a cross-sectional study and qualitative data obtained from structured interviews, surveys and group discussions with stakeholders to report the effectiveness of the DR care pathway and evaluation of the implementation strategy.We will use logistic regression models to assess crude associations DR and sight-threatening diabetic retinopathy and fractional polynomials to account for the form of continuous covariates to predict uptake of DR screening. The primary effectiveness outcome is the proportion of patients in the non-communicable disease register with diabetes screened for DR over 12 months. Other outcomes include cost-effectiveness, safety, efficiency, patient satisfaction, timeliness and equity. The outcomes of evaluation of the implementation strategies include acceptability, feasibility, adoption, appropriateness, fidelity, penetration, costs and sustainability. Addition of more family health centres during the staggered initial phase of the programme will be considered as a sign of acceptability and feasibility. In the long term, the state-wide adoption of the DR care pathway will be considered as a successful outcome of the Nayanamritham study. ETHICS AND DISSEMINATION: The study was approved by Indian Medical Research Council (2018-0551) dated 13 March 2019. Study findings will be disseminated through scientific publications and the report will inform adoption of the DR care pathway by Kerala state in future. TRIAL REGISTRATION NUMBER: ISRCTN28942696.

Secondary prevention of stroke by a primary health care approach: An open-label cluster randomised trial.

BACKGROUND AND AIM: Increasing stroke burden in developing countries necessitates measures to strengthen health systems. We aimed to evaluate whether a Community Health Worker (CHW) based educational intervention will improve risk factor control among stroke survivors and enhance behavior change communication. METHOD: An open-label, cluster-randomized trial was conducted in rural area of Thiruvananthapuram district, Kerala from December 2017 to December 2018. A CHW-based educational intervention in addition to standard of care was provided in intervention arm and compared to standard clinical care in the control arm with follow-up at three and six months. The primary outcome measures were risk factor control and quality of behavior change communication provided by CHWs. RESULTS: Of the 234 Stroke/TIA survivors enrolled, the mean age (SD) was 59.43 (11.07) years. At 6-month follow up, all patients with smokeless tobacco consumption had quit in the intervention arm (5 at baseline and 0 at six months) and no relapse in smoking was found (as compared to control arm wherein 9 at baseline and one at 6 months). The control of hypertension and diabetes was not significant at 3 months and 6 months in both intervention and control groups. Home visits as well as health education on risk factors by CHWs in the intervention arm were significantly higher. CONCLUSION: Community health worker-based intervention is feasible in resource constrained settings for secondary stroke prevention. Training of CHW on risk factor control and lifestyle modifications for stroke survivors enhances quality of health education provided by health services.

The first state-level public health program for obstructive airway disease in India: An early field-level evaluation.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the second leading cause of mortality in India; however, there are no programs for COPD in India at primary care level. Kerala became the first state in India to implement a program at primary care for COPD, called the Step Wise Approach to Airway Syndrome program. OBJECTIVE: The objective of the study was to evaluate and document the implementation status of a program for obstructive airway disease (OAD) in Trivandrum district of Kerala state in India and compare the treatment characteristics of patients with OAD seeking care from the centers implementing and not implementing this program for OADs. METHODS: A cross-sectional study was done as early evaluation of a program for OAD implemented in Kerala state, India, from October 2018 to February 2019. RESULTS: A reflection of the health-seeking behavior due to better facilities at the FHCs. There was no difference in the hospital visits or emergency department visits between the two groups. However, there was a statistically significant difference in the average number of visits per patient to health center for taking injectable drugs and visits for nebulization. Forty-nine (94%) of the COPD and 36 (100%) of the asthma patients underwent spirometry from implementing center itself. A higher proportion of patients receiving care from implementing centers (30.9%) never had to buy inhalers from outside. CONCLUSION: This is the first time that a public health programme for chronic respiratory disease management at primary care level was evaluated in India. The study has provided valuable insights on the need for strengthening the training for health care providers as well as patient education in bringing about a change in patient attitudes.

Lung Health Care pilot project trims patient pill load and antibiotic prescription in primary health care settings in Kerala, India.

INTRODUCTION: Kerala, the southern Indian state piloted Lung Health Care Project (LHCP) which is a locally adopted version of WHO recommended Practical Approach to Lung health (PAL). The current study assessed the impact of the project on the prescribing practices of doctors and consumption of antibiotics and other drugs. METHODS: This study compared performance of primary health care institutions with regard to drug prescriptions and consumptions before and after the implementation of the project. Chronic respiratory disease (CRD) patients in institutions implemented the project were interviewed in the OPD at exit and their prescriptions were documented at baseline and after six months. Focus group discussions were conducted with doctors to explore the reasons behind changes in drug consumption pattern. RESULTS: In the project implementing institutions, mean number of drugs prescribed for CRDs was 3.88 (SD 1.50) and 2.73 (SD 1.18) at baseline and after six months respectively (p < 0.001). Adjusted odds ratio for prescribing an antibiotic and injection to a CRD patient during impact assessment at institutions implementing project was 0.34 (95% CI 0.15-0.75 p 0.008) and 0.39 (95% CI 0.20-0.74 p 0.004) respectively, as compared to baseline. The factors which helped in reducing antibiotic and injection use as felt by the doctors were presence of a protocol, good quality trainings, supportive supervision and monitoring, availability of alternate drugs and good participation of staff nurses especially in-patient education. CONCLUSION: Strict adherence to diagnostic and management algorithms of Lung health care project in a primary health care setting in India helped in reducing pill burden to patients and prescription of antibiotics and injections.

Improving Access and Quality of Palliative Care in Kerala: A Cross-sectional Study of Providers in Routine Practice.

BACKGROUND: Expanding access and improving quality of palliative care in low-middle income countries is a pressing priority. OBJECTIVE: The objective of the study was to describe structure and processes of care across government (GO) and non-GO (NGO) palliative care providers (PCPs) in Kerala, India. DESIGN: This was a cross-sectional telephone survey. SETTING/SUBJECTS: This study consisted of 200 randomly selected PCPs across Kerala. The survey explored organizational structure, patient assessment, opioid availability, and explored elements considered essential to palliative care delivery in the Indian context. RESULTS: One hundred GO and 100 NGO PCPs agreed to participate (100% response rate). The annual median number of new patients was 183 and 159 in GO and NGO PCPs, respectively. The median number of annual home visits in GO PCPs was 1398 and in NGO PCPs was 979. Median number of outpatient visits in GO PCPs was 600 and in NGO PCPs was 520. Only 24% (47/200) of the PCPs had full-time physicians with training in palliative care; 60% of GO PCPs had no full time physician with training in palliative care. Patient-reported pain was routinely documented by 21% (21/100) and 65% (65/100) of the GO and NGO sites, respectively (P < 0.001). None of the GO and only 36% (36/100) of NGO PCPs were able to prescribe oral morphine. Psychosocial and spiritual issues were documented routinely in only 4% (4/100) and 48% (47/99) of the GO and NGO PCPs, respectively (P < 0.001). CONCLUSIONS: Caution is needed against potential challenges to quality care in any new initiative. Kerala has achieved remarkable success in the coverage of palliative care through hundreds of locally active NGOs through GO machinery involving every primary health center. Yet, there are gaps such as absence of full-time physicians. This study highlights the need for periodic review to identify gaps in care.