Background
Operational research studies have recently demonstrated the feasibility of large scale ART programs within public sector, based on satisfactory clinical outcomes such as survival and treatment success [
1‐
3]. While population health
outcomes are a natural focus of health services research seeking to determine the effectiveness of a public health intervention, they are determined by multiple factors classified under “quality of process” and “quality of structure” [
4]. Quality of
process relates to the actual delivery of care, including adherence to proven standards of care (diagnostic and treatment testing algorithms and guidelines) and the ability to communicate and build trust with patients [
5]. Quality of
structure relates to physical characteristics (facilities and equipment, how they are organized and managed, the operating hours of the facility etc.) and human characteristics (skills and qualifications of the staff and their level of motivation and job satisfaction) of the organizational environment within which care is delivered. The structure-process-outcome framework [
4] relates these components to final patient outcomes.
Motivated by chronic human resource shortages in rapidly growing HIV treatment programs in sub-Saharan Africa [
2], health services researchers have followed two broad lines of inquiry into quality of care. First, recent studies have measured structural factors of service delivery such as worker satisfaction and motivation [
6‐
9] and have uncovered a number of predictors of dissatisfaction. These include public vs. private sector employment, workload, availability of resources, salaries [
10], and low levels of staffing, management support and control over their practice [
11]. Second, other studies have documented the gap between desired and actual quality of care along structure, process or outcome dimensions [
12‐
14]. However, few studies have examined whether structural and organizational factors are determinants of quality of care in these resource-limited settings.
Research from developed countries, focusing on surgical procedures in acute care settings, suggests that motivation and burnout levels of staff can contribute significantly to differences in quality of care [
15,
16]. However, specific components of that can impact the quality of care vary across different settings [
17]. In developed countries, these include complexity of medical technology, number of chronic non-communicable diseases and expensive and fragmented healthcare delivery systems [
5,
18,
19]. In developing countries, additional factors that have been suggested include weak physical infrastructure, poor professional working environment and healthcare worker shortages [
17,
20].
This study seeks to address a gap in the literature by exploring the relationship between structural factors and quality of process in the context of HIV care and treatment delivery in Zambia. We investigate how physical space, level of staffing, staff burnout, staff absenteeism, staff experience and facilities’ experience with ART provision are associated with levels of adherence to clinical protocol (in this case national guidelines requiring certain laboratory tests) as part of Zambian HIV care and treatment program.
Program description: HIV care and treatment
In Lusaka, Zambia, a large-scale public sector HIV care and treatment program has been run by the Zambian Ministry of Health (MOH) since April 2004. Clinical care, patient tracking, and outcomes monitoring for the Lusaka program are standardized across all primary healthcare facilities aligned with national guidelines for adult HIV treatment [
3,
21]. Within each facility, ART departments are usually staffed by two to six nurses and supported by two to five lay healthcare workers. This is comparable to the number of healthcare professionals in typical maternal and child health departments, but higher than that in the outpatient departments in the same clinics. At enrollment, patients undergo physical examination to determine WHO stage of HIV infection. This, with the patient’s CD4 count and other investigations, determines the extent of immune suppression and the eligibility to start antiretroviral therapy. Other blood tests are done during follow-up visits as required by national guidelines.
In the clinics in this study, nursing staff collected all samples on-site. Samples were labelled and collected according to a twice-daily schedule, and transported to the Centre for Infectious Diseases Research in Zambia (CIDRZ) central laboratory for processing. All results were processed before being printed in hard copy and returned to clinics using the same twice-daily transport schedule between 5–10 working days. Hard copy results were then entered electronically in patients’ files by on-site data entry clerks and finally filed in patients’ medical files by registry staff. Availability of tests including commodities in Lusaka was extremely reliable, and there were no financial barriers for testing. Provision of all care and treatment in the ART clinics was free, including all laboratory investigations. However, logistical breakdowns in the labelling and transport of specimens, the return of results and their entry into the patient database should be considered as limitations in our causal analysis.
Discussion
This, to our knowledge, is the first study regarding the association of structural and organizational factors with quality of HIV care in resource-limited settings. Specifically, we investigate the drivers for variation in adherence to laboratory testing protocol by health care workers across facilities. Adherence to these tests is critical to ensure good patient outcomes because WHO staging and CD4 count at initial visit are critical inputs to initiation of ART. In the presence of resource constraints, adherence to protocol and making right decisions also has implications at the population level. For instance, initiating an ineligible patient on ART without conducting all the tests also implies not initiating another eligible patient on ART. Similarly, not conducting certain tests for monitoring can have undesired consequences, especially if the frequency of these tests is low.
Our results indicate that health workers adhere to similar aspects of treatment protocol more strictly during initial visit than follow-up visits. This could be because the initial visit is more standardized whereas follow-up visits are more customized depending on the patient’s health status. Also, initial assessment can be construed as more critical since it determines treatment eligibility. Moreover, there are significant differences in the associations of organizational factors with adherence to protocol in initial versus follow-up visits.
The importance of physical space in ensuring quality of care in resource-limited settings has been mentioned before in the literature [
20] and overcrowding has been cited as one of the primary drivers of inadequate care in emergency rooms [
24,
25]. However, ours is the first study that provides empirical support for this notion. The procedure of taking blood requires time, space and privacy, which might explain why increased space was associated with higher odds of ordering and conducting repeat CD4 test. In addition, limited physical space creates a situation of crowding, convoluted patient flow, which can aggravate and confuse staff and patients leading to compromised quality of care.
Some seemingly counterintuitive findings could be related to the design of clinical protocols with some staff cadres permitted to perform specific activities but not others. For instance, nurses are required to double-check the ordering of blood tests during FUP visits to minimize the impact of clinician oversight. This potentially explains the findings that burnout
increases the odds of conducting CD4 test during FUP visits. It is plausible that burnout amongst clinicians, who tend to be the most overloaded and therefore most stressed, may be (over) compensated for by less burnt out nursing staff [
11].
Similarly, the result that greater staff experience decreased and higher staff turnover increased the odds of conducting tests appears counterintuitive from a developed country perspective. However, we believe that this is plausible in a high workload setting with protocolized care. For example, less experienced staff members tend to adhere better to protocols and newly introduced staff may want to demonstrate their performance to supervisors by being more compliant with protocols. This effect may wane over time as workers become complacent with attention to protocol details. More experienced staff and those who have worked at a clinic for more time may therefore put less emphasis on following protocol, relying more on personal experience or clinical judgment. This study suggests that turnover might be beneficial if it facilitates the replacement of demotivated and burnt out staff at the facility.
The results also demonstrate that some explanatory variables influence different outcomes differently. Due to the highly protocolized nature of ART and the step-by-step nature of healthcare delivery in this setting, responsibility for certain tasks often lies with different personnel in different parts of the clinic. One of the results of this style of care is that responsibility for certain tasks is atomized, making these ‘outcomes’ susceptible to different variables. For example, some outcomes are highly dependent on the staff member responsible for registering /enrolling clients, and that staff member is often different (including potentially having different training) to those responsible for WHO staging, or for those responsible for drawing blood to follow-up on test orders.
Another plausible reason for these different effects is that faced with time constraints, the staff members might prioritize their cognitive efforts on some tasks over others based on what they believe is more important. For instance, CD4 count at the time of enrolment is considered very important for all future treatment decisions. As a result, despite heavy workload and high levels of burnout, the staff members tend to not overlook this test.
Based on the authors’ programmatic experience, noncompliance to protocols is likely to be more common amongst Clinical Officers (COs) than nurses, due to the acute bottlenecks experienced at the point of patient screening, which promoted a culture of ‘clearing’ patients as quickly as possible. Nonetheless, nurses and COs working in ART maybe more compliant to protocols compared to other departments due to more a rigorous and continuous system of quality assurance checks.
The strengths of this study include the availability of electronic clinical and laboratory data on a large numbers of patient visits. We also had access to architectural data on physical space and information on levels of health care worker burnout, which was conducted in this setting.
However, there are limitations arising from the fact that the data were not originally collected for this study. The limited scope of the study prevented us from collecting data on additional measures pertinent to our objective. One such measure is leadership of nurse in-charge. Programmatic experience of authors in Zambia strongly suggests that facility-level leadership often plays an important role in adherence to protocolized care in weak health systems. However, creating a leadership index would require conducting a survey among nurses, which was beyond our scope. Future studies should develop and/or refine existing methodologies and collect prospective data to investigate this link.
Our measure of staffing was derived from administrative (payroll) database. This almost certainly results in some overestimation of the actual level of staffing in the clinic, due to unannounced absences from the facility and the practice of getting paid for the shifts but not being physically present in the clinic. Anecdotal evidence indicates that both practices were widely prevalent among clinic staff during the study period. Our measure of absenteeism was self-reported, based on the 2007 survey of healthcare workers and it did not account for unplanned absences. Our measure of experience (number of years in a particular grade) also partly captures the effect of age of the health care worker, particularly since the ART program started only 3–4 years before the survey. Thus, our results could be interpreted to imply that younger workers are more likely to adhere to the protocol because either they are open to clinic management ideas or because their education is structurally different than their old counterparts or because they are less tied to conventional ways of doing things.
There was limited variation on some of our predictor variables such as absenteeism, burnout and turnover, which may have limited the statistical power to detect significant effects. Similarly, almost all facilities performed very well on WHO staging with very little variation across facilities. These factors might explain the lack of statistically significant results for many associations. Also, the number of patients in WHO stage IV disease was very low across all facilities, potentially explaining the lack of significant associations for laboratory investigations done.
Without access to data on outcomes at the level of individual health care workers, we are unable to comment on what factors differentiate some workers from others in being more or less adherent to protocols. Moreover, we note that the results cannot be used to assess the absolute quality of care provided at the study facilities. This is because of the lack of external benchmark on what constitutes good quality care in these resource-limited settings and because the study was not designed to answer this question. Because of imperfect patient adherence to visits, we had to allow sufficient time buffer (+/− 4 weeks) in constructing our quality measures.
Our choice of urban facilities in Lusaka, Zambia’s capital, limits the generalizability of our results in other locations, especially rural regions of the country. However, these results suggest similar assessments in other resource-limited settings attempting rapid scale-up of HIV care and treatment are necessary (particularly in sub-Saharan Africa) to ensure that the relationship between structure, process and outcomes in settings utilizing protocolized healthcare delivery are understood adequately by policy makers, donors and implementers.
Competing interests
The authors declare that they have no competing interest.
Authors’ contributions
SD conceived the study, designed the analysis plan, interpreted the data, and wrote the manuscript. AOW provided data management and conducted statistical analyses. ST, AOW, MMC, CSW, MM, SR contributed to the data interpretation and provided critical revisions of the manuscript for intellectual content. All authors approved the final version for submission.