Among the 3 stakeholder groups (N=72 participants), we interviewed 38 physicians (mean age: 56± 7.8 years, 88% men), 14 non-physician health workers (38± 4.2 years, 38% men), 4 health administrators or policy maker, 100% men with mean age: 54.4 ± 5.2 years, and 16 patients (52.4 ± 6.4 years, and 62% men) and their caregivers (32.4 ± 9.5 years, and 52% men). Two physicians and a patient refused to participate in the interview due to personal reasons. Physician- and hospital-level characteristics are summarized in Table 1. Most (88%) of these participants were men, and cardiologists (78%) with >10 years of experience in practicing cardiology. On average, physicians provided care for 550 patients per month, spending 15 minutes with patients at their initial visit, and 5-10 minutes in follow-up visits. One-third of health facilities had a reminder system for clinic visit. Nearly half of health facilities had an electronic medical record keeping system and a physician performance feedback system, but these did not include audit and feedback reports for providers focusing on patient-level outcomes.
Challenges for Implementing Quality (Needs assessment)
We found major gaps in existing care that provided strong motivation to develop and implement the C-QIP strategy in patients with CVD. Salient barriers to chronic care of CVD from the patient, provider, and health system perspectives are presented in Table 2, along with illustrative quotes. Most cardiologists (80%) identified high patient volume, time-constraints, and low health literacy among patients to be greatest challenges for providing optimal CVD care. In addition to their administrative duties, 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...be it listening to their problems... then assessing and as I said because of the sheer volume we are not able to spare maybe 5-10 minutes for each patient. Sometimes we also feel that one particular patient needs more time than the other, but we are always in the rush, finishing the rounds, coming here for the OPD (outpatient department), doing ECHO (echocardiography) procedure, then the CATH (catheterization) lab, then again rounds, so I feel it is the shortage of time (greatest barrier to chronic care of CVD)”
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 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 the patient. Healing requires both preventive as well as therapeutic (efforts).” This idea of remedial approaches explicitly was common, as many recognized that lack of focus on prevention efforts such as tobacco cessation and management of other CVD risk factors such as hypertension and diabetes. This was recognized as an attitude problem: “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.” (physician).
Lack of robust communication systems within the healthcare and poor referral linkage were emphasized as barriers to provide collaborative care as described by a health administrator: “Firstly, I think there is lot of misguidance to the patient, as to how, when and where they should approach which specialty. That is the thing that is not fixed in our country.” Another challenge was paucity of electronic health records in most hospitals as one physician quoted “There is no mechanism where we monitor the follow-up of the patient. If there is a lot to follow-up, we do not remember also because nothing is computerized, no entries are made like that so sometimes they (patients) come for the follow-up”.
Two-thirds of physicians recognized that poor adherence to medications, polypharmacy and mixed recommendations from other traditional health practitioners limited quality care across diverse healthcare settings. Adherence to prescribed therapy is an important aspect of patient self-care to achieve CVD risk factor targets and to reduce the risk of cardiovascular mortality and disability. Complex factors at multiple levels affect medication adherence, such as perceived side effects of multiple drugs, low awareness and knowledge of CVD, and managing multiple pills to be taken at different time. For example, a physician stated: “One is the patient's financial condition, his intellectual condition, his understanding about the disease (that affects adherence to therapy).” Another clinician explained, “The secondary prevention (of CVD) in whom we advise them to continue medicines lifelong, but good number of them tend to stop their medicines 3 to 6 months from the time of the index event thinking that they are normal and even if after an angioplasty where it is mandatory that they have a few medicines lifelong quite a good number of them, especially on the governmental schemes get procedures done, tend not to continue medicines.”
Affordability of CVD treatment is a major consideration in low-income economies from patients’ perspectives. Particularly for those belonging to the lower socio-economic groups, including among individuals with low educational attainment, high cost of treatment and low knowledge/awareness about CVD were important concerns. On the other hand, people who are highly educated were thought to be susceptible to unreliable information from online sources. Nearly half of providers expressed concern that the misinformation epidemic circulating on WhatsApp and other social media platforms misleads patients with CVD. For example, one physician stated: “There are lot of misinformation campaign goes on WhatsApp ... Because of that, lot of mistrust has arisen in patients and they just keep on changing doctors… many of the highly literate patients who are computer savvy, they are...what I call them is misinformed... of this misinformation because of this misinformation going on in various social media, so that misinformation epidemic has to be controlled so sometimes that takes lots of time”.
Lack of patient counsellor as an interface between patients and providers was cited as another challenge, which otherwise enables patients to communicate more frequently and more clearly about their concerns with a patient counsellor. Difficulties in maintaining lifestyle changes, which includes heart healthy diet, exercise and tobacco cessation, and misconceptions around dietary and exercise habits were identified as major barriers at the patient-level. “I had consulted one place, there the doctor said like you should not walk. So, can we do walking?” (patient)
Opportunities for Facilitating Quality
The qualitative data analyzed from the lens of the Consolidated Framework for Implementation Research [19], which offers a comprehensive approach encompassing intervention characteristics, individuals involved, inner and outer settings, and the process of implementation are reported below and in (Figure 1).
Intervention Characteristics
Evidence strength and quality: Multifactorial strategies combining clinical decision support, audit-feedback reports, task-sharing, e/mHealth, and text messages are demonstrated to be more effective than single interventions in improving cardiovascular risk factor control as well as reducing death and readmission rates [21]. However, data on effectiveness and implementation of the C-QIP strategy that features EHR-DSS, NPHW support, and text messages for healthy lifestyle among patients with established CVD are lacking in Indian context. Despite limited exposure to the C-QIP strategy, when the conceptual collaborative care model and intervention components were described to the stakeholders, they perceived several relative advantages to the existing care. Physicians perceived that an EHR-DSS could help to better organize their workplace, standardize treatment protocols followed by different care teams within and among specialties, likely to reduce the time of (in)action, and reduce medication errors by busy practitioners. The mechanisms of these actions would be through timely and accurate DSS prompts, based on evidence-based guidelines, and action, which could potentially save time in patient care. “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.” [cardiologist] An EHR-DSS can encourage the prescription of generic drugs, which may reduce out-of-pocket treatment costs and improve adherence to prescribed therapy. EHR-DSS may offer additional value when used at the outpatient clinic because patient data can be used for to improve clinical care and outcomes, including patient-reported outcomes and measures of experiential quality. For example, physicians could be supported by NPHWs who will assist in collecting initial patient data on complaints, anthropometrics, and entering patient data into the EHR; this could allow for more consultation time with patients. “If you [researcher] are providing us, it [NPHW] is worthwhile, it is beautiful activity, it should be given. 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." [Health administrator]
Text message-based reminders could increase patients’ retention in care through follow-up visits as well as improve adherence to prescribed pharmacotherapy. Due to wider availability and penetration of mobile phones across age, gender, socio-economic position, and geographic subgroups, most providers and patients perceived that text message-based reminders for clinic visits, lab appointments, and healthy lifestyle would be useful and acceptable. "(E)ven a person in village today has a mobile, he (patient) has a WhatsApp, who is capable of reading anything in it." [Nurse]
“It (text messages) will be very helpful. It will be like a reminder, so I don’t think it will add on any burden…So, if I get morning message that you will have to take care of your health, I will feel very good.” [Patient]
However, physicians raised concerns about the feasibility and adoption of EHR-DSS given the diverse patient groups, CVD manifestations, and prognostic factors across different healthcare settings. Also, some respondents expressed concerns that EHR-DSS may not be successful if assistance from NPHWs were not provided to the physicians. "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." [Cardiologist]
Some respondents expressed concerns regarding the disconnect between EHR-DSS developers and end users (i.e., health care 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, and they have not used. Their [software developers] advisors are not the real-time doctors, and they have not sat through in the clinic." [Cardiologist]
Complexity: The C-QIP strategy was perceived as a complex intervention because it involves multi-level implementation strategies, actors, and integration of different disciplines. 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. Figure 2 illustrates potential benefits and concerns of the C-QIP strategy.
Individuals Involved
Knowledge and beliefs about the C-QIP strategy: Patients had limited knowledge about CVD risk factors and reported that the C-QIP strategy could enhance their self-care management and improve doctor-patient relationship. Physicians had mixed views about the EHR-DSS usability 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: "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." [Cardiologist] Technology-averse attitudes of some physicians, slow typing speed, and less familiarity with computer interface were cited 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, so it is mind set, so there is a barrier within my own learning thought process."
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.
Inner Setting
Culture, readiness for implementation and structural characteristics: The inner setting is recognized as an active, interacting facet in implementation research. Key stakeholders at all levels openly expressed about what works and what does not to improve quality of CVD care. The 4 hospitals selected for the C-QIP trial are large, tertiary care teaching hospitals with a mix of 2 government (All India Institute of Medical Sciences, and GB Pant Hospital, New Delhi, India) and 2 private hospitals (Sir Gangaram Hospital, New Delhi and SDM Hospital, Karnataka, India). CVD management teams at these 4 sites included the senior consultants (n=2-4), and professors in cardiology (n=2-4), associate professors in cardiology (n=4), senior residents (n=6-8), staff nurses (n=10), and physician assistants (n=2). Physicians and nurses served on rotational basis across both inpatient and outpatient settings. All 4 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. To improve the usability and acceptability of text messages, key informants suggested to make it available in the local language. Physicians raised concerns about obtaining legal permission, patient confidentiality, and data privacy issue with the introduction of EHR-DSS:"(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 will take away the human angle/touch from the care system.. so, it is very difficult to manage and convince the “so called” CEO of this system with several stakeholders that is the biggest challenge(to) implementing it" [Cardiologist]
Most participants 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
Patients’ needs and resources: Almost all providers and administrators were of the opinion that the C-QIP strategy should address patient barriers (e.g., low health literacy, cost of care, and poor adherence to pharmacotherapy) and should provide patient choices about various services part of the C-QIP strategy. 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.
External policy: Given the epidemic proportion of CVD burden in India, the evidence-practice gaps in implementation of effective interventions, as well as heterogeneity in access and care delivery, the proposed multifaceted C-QIP strategy complements the existing infrastructure and activities emanating from the national program for prevention and management of CVD in India.
Process of Implementation
Physicians and health administrators were willing to change and adopt the C-QIP strategy as they believed it will mitigate several structural and systemic barriers to quality care, such as lack of patient counsellors, poor referral linkages, lack of monitoring systems, and low health literacy among patients. This formative, qualitative study is part of a multi-step exploration and preparation process that included a scoping review, multi-stakeholder interviews, and expert consultation meeting to inform the development and implementation of the C-QIP strategy. Costs associated with this new care delivery model is important to inform feasibility and adoption of the C-QIP because for most patients in India treatment cost is a primary concern over the continuity of care (i.e., routine clinic visits or testing). Public-private partnerships may be explored in future to scale-up if C-QIP strategy is proven successful. Some providers’ and administrators’ concerns include: "it (C-QIP strategy) should be cost effective, (and) it should not increase the cost of the care." (Physician)
“I think the government will have to take help from private groups to do this (scale-up). Programs which are primarily driven by government doesn’t work usually (to scale-up a program), but if they are public-private partnership will work…So basically, the government has the bandwidth and the ability to have lot of things in place, they have the hospitals, people but they don’t have trained personnel.” (Health administrator)