Provider experiences of the implementation of a new tuberculosis treatment programme: A qualitative study using the normalisation process model

Globally, over two million people die from tuberculosis (TB) each year [1]. In South Africa, the incidence rate of TB is one of the highest in the world (approximately 960 per 100000 in 2007), but it is estimated that only 70% of patients are successfully treated [1], despite the widespread use of directly observed therapy (DOT) to maintain treatment adherence. It is also estimated that approximately 73% of TB patients in South Africa are infected with HIV [1]. Providing integrated treatment for TB and HIV could result in the more efficient use of human resources and more convenient and effective care for people living with these illnesses. The differing models of treatment used for these two diseases do not, though, facilitate easy solutions to integrating treatment at community level, suggesting that a change in treatment models is needed to improve their compatibility.

The ART community treatment model, which is based on intensive treatment counselling and preparation; self-supervised therapy; community-based lay treatment support; and regular follow-up by health professionals [2] may have potential for the delivery of TB treatment. In South Africa, ART programmes achieve higher treatment adherence in selected settings (over 80% at six months [3, 4]) than DOT programmes (approximately 60% in South Africa overall [5]). Some of the reasons for poor adherence to TB treatment could include access to health care services; treatment side effects; beliefs about treatment and motivations to take it; conflicting priorities, for example the need to earn a living; discrimination and stigma; and social pressures not to take medication [6]. In addition, systematic reviews have contested the effectiveness of DOT for both TB [7] and ART [8], although a recent trial shows some benefits of the approach for ART [9]. While both TB and ART programmes use lay health workers, there is a stronger focus in the ART programme on patient rights, treatment preparation, motivation and social support [10], sometimes referred to as an 'empowerment approach'. While the need to change treatment models and to better integrate care delivery for TB and HIV/AIDS is discussed widely, the focus is generally on the health care system as a whole, and much less on the experiences or attitudes of the staff who need to implement such programmes in their clinics or communities. As in many settings, providers in South Africa are already under considerable pressure in their workplace - clinics are often crowded and understaffed, have scarce resources, and there is insufficient time for communication with patients [11‐13]. This may affect providers' responses to new initiatives.

The City of Cape Town in South Africa recently piloted a new programme, based on the ART model, with the aim of improving TB treatment adherence. The aim of this paper was to explore provider perspectives of the implementation of the new TB treatment adherence model, the Enhanced Tuberculosis Adherence (ETA) programme, using the normalization process model as an analytic framework [14].

Table 5 provides a summary of the overall results, organised according to the constructs of the NPM (see table 3 for explanation) [14].

We found a number of issues that could have promoted or inhibited the normalisation of the intervention in these clinics. The two main issues were the lack of an empowerment approach and the extent to which teamwork was embraced. These issues need to be addressed before the programme is implemented more widely.

The poor internalisation of the empowerment approach seemed to be one of the largest implementation barriers. There seemed to be a general cautiousness among health care providers regarding buying in to the programme's principles. While there have been longstanding calls for TB services to focus more on the needs of clients [21, 22], previous research has indicated that patient centred care is difficult to entrench in TB clinics [23‐25]. There is some evidence that provider training can improve the patient centeredness of care [26], but it is likely that the training for this intervention was too short to effect a change in approach.

There is also some evidence from systematic reviews that an empowerment approach may have benefits for patient care [26, 27], and HIV treatment based on this approach appears to achieve good outcomes [3, 4]. In this setting, however, distrust and power differentials between patients and staff remained important. Discussions with patients indicated that patients may not have become active participants in the treatment process, as intended by the programme [16]. The intervention's limited effect on empowerment is also not surprising given the difficulties in relationships between TB patients and providers documented extensively elsewhere [6, 28]. However, despite not achieving patient empowerment to a great degree, the programme did achieve outcomes that were not significantly different from the more coercive DOT approach [15]. It is also possible that after a longer period of training and intervention, and proof of positive impacts, the empowerment approach would be easier for staff to embrace.

Though teamwork was a major positive influence on programme implementation at some clinics, it was often tempered by hierarchical relationships [29]. As in previous research, treatment supporters felt undermined and maltreated [30] and while team members all shared a common goal, power differences remained. This hierarchy may have its roots in the hierarchy present in medicine in general [13] and may be difficult to modify. Problems with teamwork have been reported previously in similar settings [13, 31].

Status differentials and hierarchical relationships within the clinic may also have contributed to high attrition rates for treatment supporters [32], and therefore have complicated programme implementation. Other possible contributors to attrition include the working conditions as well as the loss of older lay health workers, who did not satisfy the entry criteria for the new project. While the lay health workers employed in the ETA were more literate, they may have been more likely to leave in search of other employment [33]. Also, the older lay health workers may have been more skilled in maintaining caring relationships and providing the other intangible forms of support [34] that are important to patients [35].

Irregular payments to treatment supporters further contributed to difficulties in intervention implementation, and would need to be addressed if the programme were implemented more widely. Steady payments, and possibly hiring lay workers as formal employees of the health service, might assist in retaining staff. Other work suggests, though, that payment per se may be less important in reducing attrition and improving performance than ensuring that the expectations of both lay workers and programme managers, including with regard to incentives, are in alignment [36]. Investments should also be made in other areas of lay health workers' work experience, for example in their personal safety.

The normalisation of the intervention into routine clinic care may have been further hampered by the challenge of embedding an empowerment-oriented approach and by problems with teamworking, which may have resulted in dilution of the original intervention or diversions from its original aims. However, other factors also could have impacted on the normalisation of the intervention, specifically those related to the performance, execution and realization of the programme. Though staff generally coped with the impact of the programme on their work, they all identified training needs and highlighted day-to-day challenges, especially in terms of the high attrition rates for lay health workers and space constraints within the clinics. All staff also noted their difficulties in managing issues related to HIV/AIDS that were raised by patients during consultations. Not surprisingly in a context with a high rate of TB-HIV co-infection [37], patients do not compartmentalize the two diseases in the way that the health system does [38] and staff encounter issues related to HIV when discussing TB treatment. Ensuring that one carer manages both diseases could also help alleviate human resource constraints [39], and reduce duplication of effort. A positive influence to implementation was the introduction of a project manager, to whom staff turned when in need of training, stationery or general support. However, it is not clear whether the resources to employ a highly skilled manager would be made available in a wider roll-out of the programme. Overall, our data highlight the need for mentoring and supervision of staff at clinic level [40].

Overall, the NPM [14] assisted in identifying factors that affected the embedding of the programme within the clinics. The model provides a categorisation of the issues involved, which enables the development of recommendations for similar interventions. The challenge of implementing the NPM is that many of the categories within it overlap, and issues emerging from the interviews and FGDs may be closely interrelated and so may be difficult to assign to a single category. In addition, not all of the parts of the NPM could be addressed from the interview and focus group discussion data available; for example, nurses did not mention many issues related to the execution of the programme, possibly because they were not aware of decisions made at a higher managerial level. Observations therefore were used to supplement the model. Further work to develop tools and methods to assist in the use of the NPM would be helpful. It is also important to keep in mind that staff may have used the interviews and focus group discussions as an opportunity to raise their concerns regarding the new intervention programme, and so data on promoting factors may have been less forthcoming than data on inhibiting factors. However, the critical views of the programme expressed during data collection suggest that most participants were comfortable in expressing their opinions to the researcher.

Although staff highlighted many challenges, it is interesting to note that all clinics opted to continue with the ETA programme after conclusion of the pilot, suggesting that staff had formed positive opinions of the new approach. Further research needs to be conducted, however, to establish whether the effects of the programme are sustainable without the intensive monitoring systems used in the pilot. While these results have been obtained from a specific setting in South Africa, the implications of the findings could be applied more widely in settings with similar conditions. Table 6 includes a number of recommendations for further implementation.

Given the high rate of TB-HIV co-infection, the use of a more empowerment oriented community approach instead of DOT may assist in providing more patient centred treatment and paving the way for the better integration of TB and HIV care. Our results emphasise the need to plan carefully a major programme shift such as this. The NPM has assisted in categorising the issues impacting on efforts to shift TB treatment support from DOT to a patient centred programme. Though the intervention under study experienced a number of challenges, it may, with more development, training and attention to teamwork, present a treatment support option for TB that could be integrated more easily with the ART model.

SA has a PhD in international health and was employed at the South African Medical Research Council at the time of this study. SL has a PhD in medical sociology and is employed at the South African Medical Research Council and the Norwegian Knowledge Centre for the Health Services. KCR has a PhD in social medicine and is employed as a professor of public health at the Nordic School of Public Health, Sweden. AT is a medical doctor and has a PhD in global health and is employed at Karolinska Institute, Sweden. SA, SL and AT have a longstanding interest in tuberculosis treatment models.