Design

This qualitative study was designed to inform development and implementation of the C-QIP strategy (consisting of EHR-DSS, NPHW, and text messages) to ensure that it addressed the myriad factors that can facilitate, as well as impede, collaborative care programs in India for patients with CVD. A prospective feasibility randomized controlled trial (RCT) will assess the effectiveness and acceptability of C-QIP strategy involving 400 patients with CVD attending four diverse public and private hospitals in India [19]. Since our goal was to standardize outpatient care delivery models for patients with CVD, we drew insights through semi-structured interviews with care providers, health administrators, patients, and caregivers in India. We drew upon key informants’ experiences from several clinics from different parts of India and focused on what worked and what did not within and around the QI strategies for CVD care. Further, we used qualitative interviews to capture how people perceived CVD management using QI strategy (such as use of EHR-DSS, NPHW, and patient-facing text messages to encourage healthy lifestyles), in their everyday lives from various perspectives, including at the provider, health administrators, patient, and caregiver levels. The data collected can inform implementation of the C-QIP strategy to address clinical quality, including related to patient-reported experiential measures – like feeling included or heard, being included and respected, and being recognized as a central or peripheral feature of the collaborative care – which may facilitate or impede success. The study was approved by the Institutional Ethics Committee of the Public Health Foundation of India. Before conducting the interview, informed consent was obtained from the participants, and interview data were deidentified to ensure confidentiality.

Setting and participants

This study was conducted among three different groups of stakeholders: 1) health care providers, 2) health administrators, 3) patients, and their caregivers. Health care providers constituted physicians, cardiologists, nurses, community health workers, and pharmacists engaged in providing care for patients with CVD. We used a purposive sampling frame to select an initial sample of participants who had diverse roles and experiences in the care of patients with CVD ranging from cardiologists and physicians to cardiac care unit nurses, pharmacists, community health workers to health administrators and policy makers. We then used a snowballing sampling technique based on the in-depth interviews to recruit additional participants with increasing variability until we achieved theoretical saturation, the point at which no novel concepts seemed to emerge. The four hospitals selected for the C-QIP trial are large [19], tertiary care teaching hospitals with a mix of two government (All India Institute of Medical Sciences, and GB Pant Hospital, New Delhi, India) and two private hospitals (Sir Gangaram Hospital, New Delhi and SDM Hospital, Karnataka, India). The health care administrators, patients, and caregivers were interviewed from these four hospitals in Delhi and Karnataka. Figure 1 depicts the location of four hospital sites for the Feasibility RCT, and other key informants interviewed in this study.

Current practices and challenges to CVD care in India

Table 2 summarizes salient barriers to chronic care of CVD from the provider’s and patient’s perspectives. Most physicians expressed high patient volume, time-constraints, and low health education among patients to be greatest challenges for providing quality CVD care. Physicians found insufficient time to provide care in the first place. One cardiologist explained, ‘Volume is too high that we are not able to spend time with each patient in a proper way.’ Further, there are too few specialists and too many patients that need specialty care. One out of every three providers identified ‘physician burnout’ to reflect, what they called, a ‘cultural syndrome’, described by one provider as when clinicians ‘are no longer interested to be actively involved in patient management’ because ‘the load is so much, every person has overloaded system, so in an overloaded system a single doctor cannot treat so many cases.’ He went on to explain, ‘most of the time is going in treating the patient and not in healing. Healing requires both preventive as well as therapeutic (efforts).’ This idea of remedial approaches was common, as many recognized that there is a lack of focus on prevention efforts such as tobacco cessation. This was recognized as an attitude problem of physicians: ‘The attitude needs to be changed. We wait for the disease to develop and all the efforts of all the corporate hospitals and everybody is just for the disease to occur so that now they can be rectified. There is nobody interested in preventing the disease.’ Lack of robust communication and referral systems, including paucity of electronic health records, emerged as barriers to quality CVD care as described by a health administrator: ‘I think there is lot of misguidances to the patient, as to how, when and where they should approach which specialty.’ Another physician added ‘There is no mechanism where we monitor the follow-up of the patient’, emphasizing a gap in care coordination.

Further, most physicians recognized that poor patient adherence to medications, polypharmacy and mixed recommendations from other traditional health practitioners influenced chronic care of CVD. For example, a physician stated:

‘The secondary prevention (of CVD) in whom we advise to continue medicines lifelong, but good number of them (patients) tend to stop their medicines three to six months from the time of the index event thinking that they are normal, especially (those patients) on the governmental schemes get procedures done, tend not to continue medicines.’

Affordability of CVD treatment emerged as a greatest challenge from patients’ perspectives. Particularly for those belonging to the lower income groups, including among individuals with low educational attainment, high cost of treatment and low knowledge/awareness about disease were major barriers. On the other hand, people who are highly educated were thought to be susceptible to unreliable information from online sources according to physicians. The care providers expressed concern that the misinformation epidemic circulating on WhatsApp and other social media platforms mislead patients with chronic conditions. For example, one physician stated: ‘There is lot of misinformation campaign goes on WhatsApp … Because of that, lot of mistrust has arisen in patients, and they (patient) just keep on changing doctors, so that misinformation epidemic has to be controlled…that takes lot of time.’ Difficulties in maintaining lifestyle changes, and misconceptions around dietary and exercise habits also emerged as barriers from patient perspectives.

Barriers and enablers of implementing C-QIP strategy

Figure 2 illustrates perceived benefits and concerns around implementing the C-QIP strategy. Further, we mapped the barriers and enablers of implementing the C-QIP strategy using CFIR domains to inform an implementation research logic model depicting the determinants, implementation strategies, hypothesized mechanisms and desired outcomes (Figure 3). The key determinants that influenced the implementation strategies to be evaluated in a prospective feasibility RCT were synthesized using the five domains postulated by CFIR and is discussed further in the following.

Intervention characteristics

The C-QIP strategy combines clinical decision supported electronic health records, task-sharing via trained NPHW, and patient-facing text messages with healthy lifestyle advice to improve CVD care quality. Physicians thought that implementing the C-QIP strategy would standardize treatment protocols and reduce medication errors as they will receive alerts or clinical decision support prompts for timely treatment modification. This was best summarized by a cardiologist, ‘So, given the busy clinic we (physician) miss out on certain essential prescription drugs which need to be there for heart failure patients for example. This DSS prompt can be an alert for the physician if something is missed in the prescription.’

EHR-DSS may offer additional value as it will endorse prescription of generic drugs, which can reduce out-of-pocket medical expense, and electronically stored patient data can be used for research purpose (e.g., big data analytics) to inform clinical decision making. Further, physicians supported the use of NPHWs to facilitate care for patients and assist in collecting/recording patient data into the EHR, thus allowing more consultation time with patients as described by a physician health administrator, ‘it (C-QIP) is worthwhile, it is a beautiful activity. I strongly recommend that. 90% of your problems and recurrence will be stopped if you are able to modify the lifestyle, motivate them (patients) to modify their lifestyle.’

The disconnect between EHR-DSS developers and end users (i.e., health care providers) emerged as a major deterrent to the use of EHR-DSS by the providers. One physician stated: ‘Majority of them [EHR-DSS] are designed by non-medicals and they are designed in the IT lead offices who have really not visited the doctors. Their [software developers] advisors are not the real-time doctors, and they have not sat through in the clinic.’ Further, few physicians had concerns about the fidelity of physicians’ use of the EHR-DSS given the varied CVD manifestations, and prognostic factors. Assistance from NPHWs for patient intake and entry into EHR was deemed critical for the success of C-QIP strategy as stated by a physician: ‘Although some hospitals have introduced all this [EHR-DSS] in the outstation, I believe these physicians just do not use the computer, because to just enter all this data, it takes so much time, I am not going to do it.’

Text message-based reminders were thought to be useful and acceptable to both providers and patients as it may increase patients’ retention in care through follow-up visits as well as improve adherence to prescribed therapy. This was best supported by a nurse: ‘[E]ven a person in village today has a mobile, he [patient] has a WhatsApp, who is capable of reading anything in it.’ And, a patient described that, ‘If I get morning message that you will have to take care of your health, I will feel very good.’ To improve the usability and acceptability of text messages, key informants suggested to make it available in the local language.

Inner setting

All four study sites selected for the feasibility trial lack an EHR-DSS system at baseline, use NPHWs in a minimal capacity, and do not use text messages to support patients’ self-care and management. Physicians had concerns about obtaining legal permission, patient confidentiality, and data privacy issue with the introduction of EHR-DSS as described by a cardiologist: ‘it is very difficult to manage and convince the “so called” CEO (health administrators) of this system with several stakeholders that is the biggest challenge (to) implementing it.’

However, most key informants described that the hospital leadership strongly supports clinic change efforts to improve quality and will provide necessary support in terms of financial resources, training, staffing, equipment, and materials to cater to patients’ needs and improve quality of care.

Outer setting

Almost all providers and administrators believed the C-QIP strategy should address patient barriers (e.g., low health literacy, cost of care, and poor adherence to pharmacotherapy) and provide patient choices about various services in response to patient needs as a part of the C-QIP strategy. Stakeholders emphasized that to increase the acceptance of NPHW facilitated care, a cultural shift and sensitization along with policy-level changes related to NPHW scope of practice regulations are needed. Physicians reported understanding the needs of their patients. as expressed by a private clinic physician: ‘typically, even today patients and relatives do expect the medical doctors to do this job (counselling) for them.’ Another private practitioner reflecting on known barriers to patient care stated, ‘There could be certain barriers because the patient and his family may not like it (NPHW delivered care). But maybe, we can make it change (by cultural shift) and that should be the way.’ If the C-QIP strategy is found to be effective, it can complement the existing infrastructure and activities emanating from the national program for prevention and management of CVD in India.

Characteristics of individuals

Providers had mixed views about the EHR-DSS adoption and effectiveness but strongly believed in the involvement of NPHWs to provide patient counselling/education and text messages for chronic care of CVD. A few senior consultants also opposed the use of EHR-DSS as quoted by a cardiologist, ‘Decision support systems are something for people who don’t have their own algorithms in their own mind. For most of the people who have grey hair, they will actually reject them.’

Technology-averse attitudes of some physicians, slow typing speed, and less familiarity with computer interface were quoted as barriers to the wider acceptability and adoption of EHR-DSS as concerned by a physician: ‘They (physicians) would be so resistant to use computers [EHR-DSS] because it takes time for learning.’ Health administrators expressed that dedicated human resources (i.e., NPHWs) and information technology and administrative support would be necessary to effectively implement the C-QIP strategy.

Process of implementation

This formative, qualitative study is part of a multi-step exploration and preparation process that included a scoping review, multi-stakeholder interviews, and an expert consultation meeting to inform the development and implementation of the C-QIP strategy. The C-QIP strategy was perceived as a complex intervention because it involves multi-level implementation strategies, implementation actors, and integration of different disciplines. The complexity of the intervention drives the need for a clear plan to engage all implementation actors, educate them about the intervention, and encourage the adoption of the C-QIP strategy, as captured by a cardiologist:

‘(In) tertiary care system where there is a lot of disbelief for newer strategies while some people are very forthcoming to the top technologies, there are some who are absolutely against it because that (technology) will take away the human angle from the (health) care system…’

To reduce the complexity of the C-QIP strategy, key informants suggested to provide standard operating procedures and have uniformity in data collection, entry, and execution of DSS plan. The coupling of policy change and the use of NPHWs as intervention champions was perceived as one way to help create an environment that facilitates implementation of the C-QIP strategy. As quoted by a physician administrator:

‘I sincerely hope that because we have introduced DSS in the National program (for CVD, Diabetes, and Hypertension) so I hope it takes up, but I think there is a lot of push back from physicians to such systems…we need physician assistant to help with that work (manage EHR-DSS) that will help bring these things in a more structured way and address CVD burden more efficiently.’

Physicians, health administrators and patients were willing to change and adopt the C-QIP strategy as they believed it will mitigate several structural and systemic barriers to CVD care, such as lack of patient counsellors, poor referral linkages, lack of monitoring systems, and low health literacy among patients.

Strengths and limitations

Through the analysis and interpretation of in-depth interviews with multiple stakeholders, we have provided insights into the current practices, challenges, and opportunities around CVD care in a low resource setting such as India. Further, our results shed light on how the interaction of different CFIR domains (intervention characteristics, inner setting, outer setting, characteristics of individuals) could guide the successful implementation of C-QIP strategy. In particular, the findings of this study described the barriers and facilitators to implementing the C-QIP strategy. A unique strength of this study is that it does not focus on providers and health administrators’ perspective but also include experiences of patients and care givers.

This study has few limitations. First, we focused on a breadth of views from diverse health system stakeholders across diverse settings as opposed to studying a single clinical setting. Because providers and patients in these setting face different challenges, the diluting of context within or across clinical settings may cause us to overlook certain facilitators or barriers to a program that might be seen when focusing explicitly on a smaller number of clinical settings. Second, patients, caregivers, and health administrators were selected from the four participating sites in the C-QIP feasibility trial, which might introduce the selection and social desirability biases. However, we utilized a purposive sampling frame to recruit key informants to achieve diverse representation and glean different perspectives on enablers and facilitators of the C-QIP strategy in India. Third, our findings are based on in-depth interviews with little observation using ethnographic methods, which could have provided insights into the actual clinic flow, dynamic interactions between clinicians, nurses, pharmacists, and patients, and process of care measures, so this study is largely based on the self-reported participants’ views and experiences.