Access to CKD Care in Rural Communities of India: A Qualitative Study Exploring the Barriers and Facilitators

Introduction Chronic kidney disease (CKD) has become a public health challenge globally, especially in lower- and middle- income countries. The implications of adverse social and economic consequences of CKD are particularly grave in a populous country like India where CKD risk factors like diabetes and hypertension are widely prevalent. Although with early detection and timely initiation of interventions CKD progression can be slowed, huge knowledge-practice gap exists. Moreover, factors that influence access to CKD care at the community level have not been studied previously. This study aimed to explore the experiences and views of key stakeholders to identify factors that influence access to CKD care in rural India. We also sought to discern the current practices and preparedness for CKD, understand the facilitators and barriers to CKD care, and feasibility and acceptability of mobile-technology based clinical decision support system (mCDSS) for CKD care in primary care.Methods Using 15 in-depth interviews and one focus group discussion (n=6), we aimed to explore the experiences and views of different stakeholdres from primary healthcare system in rural India. We employed Lévesque’s framework for access to care, and inductive and deductive approaches in the analysis. The interviews were audio-recorded and transcribed verbatim. Using QSR nVivio 11, coding and thematic analysis was undertaken.Results Our study identified barriers in relation to access to CKD care in rural India. Fore most among them was poor knowledge and lack of awareness to CKD among patients as well as primary care physicians. Health system-level barriers like shortages of skilled healthcare professionals and medicines, fragmented referrals pathways with inadequate follow up care were identified. Increasing awareness of CKD among healthcare providers and patients, provision of CKD related supplies, and a system-level approach to care coordination were key facilitators.Conclusions Lack of awareness and knowledge on CKD among primary care providers and patients, and unprepared


Abstract
Introduction Chronic kidney disease (CKD) has become a public health challenge globally, especially in lower-and middle-income countries. The implications of adverse social and economic consequences of CKD are particularly grave in a populous country like India where CKD risk factors like diabetes and hypertension are widely prevalent. Although with early detection and timely initiation of interventions CKD progression can be slowed, huge knowledge-practice gap exists. Moreover, factors that influence access to CKD care at the community level have not been studied previously. This study aimed to explore the experiences and views of key stakeholders to identify factors that influence access to CKD care in rural India. We also sought to discern the current practices and preparedness for CKD, understand the facilitators and barriers to CKD care, and feasibility and acceptability of mobile-technology based clinical decision support system (mCDSS) for CKD care in primary care.Methods Using 15 in-depth interviews and one focus group discussion (n=6), we aimed to explore the experiences and views of different stakeholdres from primary healthcare system in rural India. We employed Lévesque's framework for access to care, and inductive and deductive approaches in the analysis. The interviews were audiorecorded and transcribed verbatim. Using QSR nVivio 11, coding and thematic analysis was undertaken.Results Our study identified barriers in relation to access to CKD care in rural India. Fore most among them was poor knowledge and lack of awareness to CKD among patients as well as primary care physicians. Health system-level barriers like shortages of skilled healthcare professionals and medicines, fragmented referrals pathways with inadequate follow up care were identified. Increasing awareness of CKD among healthcare providers and patients, provision of CKD related supplies, and a systemlevel approach to care coordination were key facilitators.Conclusions Lack of awareness and knowledge on CKD among primary care providers and patients, and unprepared Introduction Chronic kidney disease (CKD), defined as reduced estimated glomerular filtration rate (eGFR) or presence of albuminuria, is associated with progression to end stage kidney disease (ESKD), needing dialysis or kidney transplant to sustain life, and increased risks of premature mortality from cardiovascular disease (CVD).(1) (2) CKD ranked 17 th and 8 th leading (and one of the most rapidly rising) cause of mortality globally and in India respectively by the Global Burden of Disease Study 2016 (3) About 1 in 5 adults over 30 years suffer from CKD in India. (4,5) Diabetes is the single largest contributor to the CKD/ ESKD burden in India accounting for 31% to 44%, other etiologies include hypertension (13%), glomerulonephritis (14%), and undetermined causes (16%). (6,7) The high burden has serious implications for a country of 1.35 billion, especially in the rural areas (66.4% of total population in India) (8) with infrastructural challenges to deliver quality care. The infrastructure for CKD and ESKD care in India is deficient with only 1850 nephrologists serving 1.3 billion people, with unequal distribution and concentration in urban areas (9). To compound the issues, lack of access to renal services such as replacement therapy (RRT) is limited, and the cost of dialysis is prohibitively expensive at US $64 per session especially as most of it is borne out of pocket (10,11). It is estimated that fewer than 10% of patients with ESKD receive renal replacement therapy. (12) There is strong evidence that development of CVD and progression to ESKD can be prevented by prompt detection of CKD and early institution of non-pharmacologic (13,14) and pharmacologic therapies. (15)(16)(17)(18)(19)(20)(21) Since patients with CKD are asymptomatic during early stages of the disease, screening may improve awareness and health seeking behavior. (22) However, CKD awareness rates are abysmally poor (6%) in India, as in other LMIC. (1,23) Moreover, only a minority of individuals with CKD and diabetes achieve recommended treatment targets for blood pressure control (22%) and glycemic control (33%) in India. (24) Evidence is growing regarding the role of trained non-physician health workers in management of hypertension and diabetes in South Asia. (25)(26)(27) Furthermore, digital platforms are being increasingly used for health promotion, as well as screening and management of non-communicable diseases. (28) However, the factors that influence access to early stage CKD care in rural communities of India and neighboring countries is yet to be studied . (29) Understanding the challenges faced by patients and providers regarding the management of early CKD is critical to designing strategies that are potentially effective for improving outcomes.
The aim of our qualitative study was to explore the experiences and views of key stakeholders (i.e. patients, health workers, and health planners) regarding factors influencing access to care of patients with CKD in rural communities of India. We also sought to discern the current practices and preparedness for CKD, understand the facilitators and barriers to CKD care, and feasibility and acceptability of mobile-technology based clinical decision support system (mCDSS) for CKD care in the primary health care setting.

Study setting and design
Our qualitative study was embedded within the Innovative M-health led Participatory Approach to Comprehensive Screening and Treatment of Diabetes study (IMPACT Diabetes study) which aimed to test the feasibility and acceptability of a comprehensive mCDSS based intervention for community-based screening for diabetes and management in the primary healthcare system in rural areas of Haryana, India. The healthcare delivery system in India, provided through both public and private sector is complex. The public sector plays a substantial role in care delivery in the rural areas, a pyramidal system with primary health centers (PHC) at the base, district level hospitals at the secondary level and the university (teaching) hospitals providing tertiary care. Among urban areas, the private sector is more dominant.
Pilot programs for screening for blood pressure and blood glucose have recently been initiated in some districts of India. Under the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases and Stroke (NPCDCS), at the subcenters of the primary health care centres, the concerned auxillary nurse midwives (ANM) is expected to screen 40% of the target population over 30 years for diabetes and hypertension and by conducting non-communicable disease (NCD) screening camps in their subcenters every week. The individuals are screened for diabetes by using glucometers and for hypertension using blood pressure apparatus, preferably mercury sphygmomanometer in sitting position and taking an average of three to four readings.
The height and weight are recorded, and body mass index calculated. The individuals who are screened positive for diabetes or hypertension or both are referred to their respective PHCs for confirmation of the disease and initiation of the treatment. Irrespective of the disease outcome, the ANM counsels the individuals attending the NCD camps for health promotion by advising them for diet modification, physical activity, stress management, avoidance of tobacco and alcohol, and about the warning signs of cancer. This programme does not cover CKD.
This study was conducted in the PHC areas served by the Pandit BD Sharma University of Health Sciences, Rohtak, Haryana, an adjacent state to Delhi. Four PHCs were selected based on convenience (accessibility of PHC and availability of the PHC physician). Within each PHC, two villages -one big (~6000 population) and other small (~3000 population) were randomly selected from all the villages being served by the PHCs. Stakeholders were selected purposively, and 3-5 individuals in each category of policymakers (district-level officials), physician-in-charge of the basic health unit in each cluster, community health workers (CHWs) and their supervisors, and diabetes CKD individuals identified in the clusters were recruited.
We developed and pre-tested the interview and focus group discussion (FGD) guides with open-ended questions to solicit the participants' experience and views concerning CKD care in rural communities. We adopted the Levesque et al's framework to design our interview guides and collect the data. (30) The guides covered topics such as knowledge and awareness of CKD, current preparedness and practice for the management of CKD, facilitators of and barriers to CKD care, and perceived usefulness of mCDSS in CKD care and management. A total of 15 one-to-one interviews were conducted on healthcare providers (HCPs) which included primary care physicians, nephrologist and community health workers (auxiliary nurse midwives-ANMs & accredited social health activists-ASHAs); diabetes patients with CKD, and district level officials. At initial data analysis of the one-to one interviews, we sensed that data saturation was not reached. Therefore, we conducted one focus group discussion (FGD) with ASHAs (n=6) in the rural areas to complement the data from one-to-one interviews. The moderators followed an interview /FGD guide and asked open-ended questions. Additional file 1 provides a synopsis of interview guides.
The one-to-one interviews lasted between 20 and 30 minutes while the focus group lasted approximately 60 minutes, these were conducted by AT and OJ. All interviews and FGD were conducted in a quiet location at the premises of the healthcare facility or local research office. The interviews were conducted in either local language (Hindi) or in English, audio-recorded and transcribed verbatim. The transcripts in Hindi were subsequently translated into English by bilingual interviewers and reviewed by the research team.

Data analysis
We employed both grounded theory approach and conceptual modelling underpinned by Levesque et al's framework (30) to collect and analyse the data. We analysed all the interview and FGD transcripts thematically. (31) The search for themes began by reading and immersing within a single transcript to draw preliminary interpretations. A list of emerging themes and their relationships allowed the themes to be grouped together as master themes. A code was assigned to each theme using QSR NVivo 11 software. The list of emerging themes was then compared to those generated through the remaining transcripts. This process allowed themes and explanations to arise inductively from the data. All themes were simultaneously mapped against the Levesque et al's framework to denote data alignment with the framework's conceptual elements and identify new themes developed inductively. Two research team members (CR, SY) independently coded a subset of data and compared coding. Consensus was reached through discussion and iterative review of codes and categories. This involved a process of constant comparison of between-and within-categories, and refining and recoding of the text until an array of interlinking themes was elicited. All codes were then reviewed together by the research team (THJ, CR, OJ, AT, BC HLQ, SY, VJ) to ensure that common themes reflected a shared understanding among participants of the phenomena under investigation. In addition, quality assessment checks for coding were performed on 20% of randomly selected transcripts by THJ. Data saturation was achieved, with no new themes were emerging from the data (see Additional file 2 for the Consolidated Criteria for Reporting Qualitative Research-COREQ).

Conceptual framework
Our conceptual framework is based on Levesque et al's access to care model, (30) and enables us to understand factors influencing access to care at the confluence of health systems and populations. The dimensions and the corresponding abilities related to five key elements of the framework are 1) approachability (ability to perceive); 2) acceptability (ability to seek); 3) availability and accommodation (ability to reach); 4) affordability (ability to pay); and 5) appropriateness (ability to engage). Moreover, the different set of dimensions interact with each other, and needs to be accounted when planning to operationalize the framework.

Results
A total of 21 stakeholders participated in the study. More than half of participants (62%) were females. Among 14 healthcare providers (HCPs), 11 were community health workers (included ANM and ASHA). Five patients and two district-level officials also participated ( Table 1). The key themes as per Levesque et al. access to care framework dimensions are presented in Figure 1.
Five themes and 13 subthemes identified inductively, and construed as barriers and facilitators are detailed in Table 2.

Approachability and ability to perceive: Stakeholders' awareness & knowledge
'Approachability and ability to perceive' refers to the healthcare providers' and patient opportunities to identify some form of CKD services that exists and can be reached (30).
Tied to this approachability concept is awareness, which relates to knowledge and influences the ability to perceive the need for care. The important barriers identified in this domain were poor knowledge and awareness of CKD among healthcare providers and patients, low risk perception among patients with delayed diagnosis and inadequate patient-provider communication. Increasing awareness of CKD among healthcare providers and patients was deemed to be a key facilitator for improving access to CKD care.

Poor knowledge & awareness of CKD among HCPs and patients
A common theme across participants' accounts was poor knowledge and awareness of CKD. As one nephrologist reported, there was a general "lack of awareness among patients and even doctors." The main issues are lack of awareness among the people and even doctors-they [doctors] are not screening for kidney disease among those with diabetes, hypertension. Physician

3, male
Primary care physicians reported that they had limited knowledge and confidence in managing early CKD. For example, although primary care physicians were familiar with terminologies such as urea and creatinine, they did not screen for CKD or were involved in managing CKD patients, and tended to refer cases to specialist centres.
Likewise, CKD awareness among CHWs was low in terms of not only general understanding of CKD, but also diagnosis, risk factors, associated complications and knowledge of patient management to prevent CKD progression. Since the CHWs' existing job scope centred on mother and child health and communicable diseases, it further constrained the CHWs from providing CKD-related services. Many CHWs had misconceptions that CKD diagnosis required multiple tests that would not be available in primary care setting.

Low risk perceptions among patients resulting in delayed diagnosis
Overall, most stakeholders perceived a progressive increase in CKD burden in the community. Patients expressed that CKD had increased over the years and "many people around them are suffering from the disease." Many healthcare providers reported an increasing prevalence of diabetes "even in the villages." Nonetheless, perceived increase in the prevalence of diabetes did not translate into the uptake of the screening as patients were not aware that diabetes was a major cause of CKD. The lack of motivation for screening and management could be explained by the absence of symptoms and hence low risk perceptions of CKD. Acceptability and ability to seek: Cultural norms 'Acceptability and ability to seek' refers to the cultural factors that influence how populations accept the aspects of services provided (30), and are usually shaped by cultural norms. An important cultural barrier to the ability to seek care was selfmedication and use of informal medicines.

Self-medication and use of informal medicines
Healthcare providers reported challenges when patients' cultural beliefs and norms were at odds with clinical recommendations. They noted the use of alternative medicines by patients to treat diabetes and CKD as a barrier to care. Indeed, patient participants reflected on self-medication or seeking non-traditional treatments from complementary medicine practitioners to treat their chronic health conditions. The following is a quote from a patient who reported taking indigenous medicines as well as allopathic medications for chronic conditions. Availability and ability to reach: Resources for CKD care at primary care level 'Availability and ability to reach' refers to the existence of health services for CKD (30) and is shaped by the availability of facilities and health resources in rural communities.

Home visits by trained community health workers for CKD care
A theme running through the data was task shifting and the potential for AHSA's role to facilitate CKD care in rural communities. The AHSA is commonly believed to be the "key person" in the rural communities and "backbone" for any program. Because ASHAs were well known in the rural communities, villagers tended to "listen to them." Patients commonly felt that home visits by ASHAs for CKD care will have "advantages", such as minimizing the inconvenience of traveling long distances and having regular blood and sugar levels checked in their homes. However, some expressed "bit of fear" since they had no prior experience with CKD while others were worried about "increase in workload" and "lack of time." Primary care providers and government officials suggested the need for "skills training" for ASHAs.
ASHAs were largely acceptable to the idea of vocational training, which, they felt, would empower them to provide relevant advice to patients.

We hope to learn everything to able to tell people how this disease [CKD] happens, what will happen if patient has this disease, what should be eaten or should not be eaten, what
is the symptom associated. One should know which doctor he/she has to see. Community health worker (FGD Participant), female

Affordability and ability to pay: Cost of medicines and treatment
'Affordability and ability to pay' refers to the economic capacity of people to spend resources and time (30). With respect to CKD, a major barrier for rural communities was cost.

Financial burden due to CKD
Some HCPs believed that due to the patients' fear of high cost, timely preparation for RRT was not feasible. It was commonly perceived that the poor are "unable to afford" treatment, and that "financial problems [associated with treatment] would break down poor man". One patient undergoing dialysis voiced the need for financial support.
Patients should get financial support. The patients should not leave their dialysis, should take a high protein diet, be physically active, and working is very important. By doing work, they will be able to earn money, and their mind will also be diverted alongside.

Patient 5, male
Appropriateness and ability to engage: Continuity of care 'Appropriateness and ability to engage' refers to the fit between services available and patient needs (30). Tied to this domain are adequacy, quality and system integration which ensure continuity of services, and influence the ability to engage. workers for screening, only a few will be diagnosed and the rest will not come out. I feel the primary health care center will do more in this case rather than accessory appliances.
Government official 2, male Table 3 provides summary of themes, subthemes and illustrative quotes.

Discussion
This qualitative study identified key barriers and facilitators for access to CKD care among rural communities of India which if addressed effectively could potentially avert several negative health, social and economic consequences associated with advanced CKD.
Foremost among them was poor knowledge and lack of awareness to CKD among patients as well as primary care physicians. . Patients lacked awareness that CKD could be detected in early stages, and healthcare providers had misconceptions that screening for CKD includes a battery of complex investigations. Low risk perception due to asymptomatic nature of early stage disease contributes to dealyed CKD diagnosis when patients were symptomatic. Other barriers influencing access to CKD care were unprepared primary health systems infrastructure (healthcare professionals, diagnostic supplies and medications), unorganized CKD referral and poor follow up pathways. We reported similar patient related factors -knowledge, attitude and geography, and physician related factors -availability, access, knowledge and attitude as barriers to optimal kidney disease care in South Asia (34).
The participants in our study identified shortage of medications and supplies as a barrier to CKD care in rural India. This is unsurprising as the ISN survey showed that only 30% of LMIC had access to health technologies like measurement of serum creatinine and urine albumin testing, none of the low income had access to eGFR and quantitative estimation of albuminuria, and low availability of essential medications for kidney disease. (36,37) Our findings underscore the need for making the very basic diagnostic supplies for CKD (urine protein dipsticks and measurement of serum creatinine), and anti-hypertensive, glucose lowering and lipid lowering medications accessible to patients with CKD. This approach would be consistent with universal health coverage, and assist with achieving the Sustainable Development Goal 3.4. Further, our findings highlights the need for creating efficiencies in the referral process, and introduce strategies for patient activation and empowerment. Patient activation could potentially help improve self-management behaviors and health outcomes. (38) In the US, the Kidney Early Evaluation Program (KEEP)-a targeted community screening program for CKD in individuals with high risk of CKD (those with diabetes or hypertension, or a first-degree relative with diabetes, hypertension, or kidney disease) has been shown to improve awareness of CKD with can improve health seeking behavior.(39) Screening for CKD has been shown to be cost effective in diabetes in HIC. (40) Similar evidence is needed from low-and middle income countries.
Preventive strategies centered on non-physician health workers have been shown to be effective for control of hypertension and diabetes. (25,41) Innovative models of collaborative care with primary care physicians and training non-physician health workers in CKD care could improve quality of services, continuity of care and address the shortage of nephrology workforce in rural areas in LMIC.

The World Health Organization Package of Essential Non-communicable Disease
Interventions promises hope for CKD prevention. To be fully effective, such strategies should focus on those at high risk of developing CKD, such as those with diabetes, hypertension, family history of CKD or exposure to environmental factors, such as manual work in hot and humid environments (heat stress nephropathy) (42), or local customs, such as consumption of traditional medicines and over the counter use of painkillers or non-steroidal anti-inflammatory drugs. These should be followed by providing guidelinebased care to those who screen positive, reducing non-adherence to therapy, and institution of quality improvement programs. Comprehensive control of CKD would involve a collaborative model of care starting from screening and identification of early stage disease, continuing through to end-of-life support for those with advanced disease. (43) Novel m-health tools for care support, endorsed as beneficial, acceptable and feasible will help strengthen health services delivery for non-communicable diseases, and such tools need further evaluation for use in resource-limited settings.

Strengths and Limitations
To our knowledge, this is the first qualitative study from rural India exploring factors that influence access to early CKD care. A key strength of this study was its inclusion of a wide range of stakeholders in the health system spanning health system leaders, community care workers and patient, which enabled us to explore various experiences and perspectives regarding CKD care in rural communities of India. The inclusion of various stakeholders not only brought greater clarity to the factors influencing CKD care, it also allowed triangulation of data grounded in stakeholders' experiences. In addition, drawing on the Lévesque's framework (30), we employed both inductive and deductive approaches to generate a nuanced understanding of the access to CKD care and how these challenges can be addressed. Our analysis has demonstrated that various dimensions of the Levesque's framework were highly relevant to holistically understanding access to CKD care in low resource settings.
Notwithstanding these strengths, findings from this study should be viewed in light of a few limitations. The small sample size in each group of stakeholders may have diluted the views of the stakeholder group. Due to the shortage of physicians in rural communities, only three physicians participated in the study. It is therefore possible that limited representation of different cadres of health professionals may have influenced the themes and suggestions generated in this study. However, this limitation was counteracted by purposively recruiting more CHWs to ensure that the results of the study represent the perspectives and inputs from healthcare providers working in the field. Similar surveys among larger sample of primary care physicians in India and other South Asian countries is needed.
Furthermore, only patients with CKD due to diabetes were included. However, diabetes is the commonest (44%) cause of ESKD in India (7), and the challenges faced in accessing care are expected to be similar for patients with other causes of CKD. Moreover, since our participants were recruited from a few selected villages in North India, findings may not be generalised to all rural communities of India. However, similar findings regarding poor awareness and weak healthcare services have been reported for hypertension management from other countries like Bangladesh, Pakistan, and Sri Lanka.(44) Thus we believe our findings on CKD would be generalizable to other countries in South Asia, and possibly many LMIC.

Conclusions
This qualitative study demonstrates poor awareness and knowledge on CKD among primary care providers and patients and unprepared primary care infrastructure to be the key barriers for access to CKD care in rural communities in India. There is an urgent need to address the system-level barriers to CKD care by increasing the awareness among primary care physicians and patients, engaging community health workers, improving supplies for diagnostics and medications for CKD in the primary care clinics, and creating efficient referral pathways. Further research incorporating m-health tools to enhance and support CKD care in diabetes could be evaluated. Such strategies could provide an opportunity to address the gaps and strengthen health services delivery in CKD care. Declarations Ethics approval and consent to participate Ethical clearance was obtained from an independent ethical review committee at Centre for Chronic Disease Control, Gurgaon, India and from the institutional review board (IRB) at National University of Singapore, Singapore. Written informed consent was obtained from all participants before each Interview and FGD. The participants were assured about the confidentiality of their responses.

Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors report no conflict of interest in this work.

Funding
The qualitative study was supported by a research grant from Duke Global Health Institute, Duke University, Durham, NC, USA. The IMPACT Diabetes study was supported by a research grant from the European Foundation for Studies in Diabetes (EFSD). The funders had no role in study design, data collection and analysis, and decision to publish, or preparation of the manuscript.  Additonal file 1_Summary of interview guides.pdf Additional file 2_COREQ checklist.pdf