In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses’ role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses’ capacity to manage NCDs.
Methods and Findings
In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses’ expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up.
Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa.
The trial is registered with Current Controlled Trials (ISRCTN20283604)
In a cluster-randomized trial done in South Africa, Lara Fairall and co-workers investigate the effectiveness of a clinical management tool for non-communicable diseases in primary care.
Why Was This Study Done?
Non-communicable diseases (NCDs) are the leading cause of deaths worldwide, even in low- and middle-income countries (LMICs) that continue to battle to control communicable diseases like HIV and tuberculosis (TB).
Effective and affordable treatments prevent complications from NCDs like heart attacks and strokes, but access is limited by the variable availability and limited capacity of primary care health workers to detect and effectively manage these conditions. In many LMICs, non-physicians such as nurses provide primary care for NCDs.
Over the past 16 years, we have developed, evaluated, and refined integrated clinical management tools and training programmes that employ problem-based approaches to common symptoms like cough and priority health conditions including TB, HIV, asthma, and emphysema. We have shown them to be effective in improving the quality and outcomes of care for communicable diseases.
We have expanded this programme to include almost all NCDs and mental health. This study evaluated the impact, both benefits and harms, of introducing the expanded programme, called Primary Care 101 (PC101), in terms of the quality of primary care for four common chronic diseases: hypertension, diabetes, chronic respiratory disease, and depression.
What Did the Researchers Do and Find?
We compared the care offered to patients with one of these four chronic diseases in 18 clinics in which primary care health workers were trained in the use of PC101 with that in 18 clinics where nurses continued to use the predecessor tool, which focused on communicable diseases.
The trial had a pragmatic design, meaning it was conducted under usual conditions of health system operational constraints. Clinics in urban and rural areas serving people living in socio-economically deprived areas of South Africa were selected.
We enrolled 4,393 patients with one or more of the NCDs of interest and followed them up for 14 mo after introduction of PC101 at the intervention clinics. The primary outcome of interest was intensification of treatment (or diagnosis, in the case of depression) for the four NCDs, analysed separately.
The results confirmed very high rates of multimorbidity (patients having more than one condition at a time), under-diagnosis, under-treatment, and poor disease control.
Introducing PC101 did not result in intensification of treatment for the four NCDs, but neither was there evidence of harm from the nurses’ expanded scope of practice.
What Do These Findings Mean?
The trial confirmed that multimorbidity and poor detection and control of NCDs and depression are common in this setting. Interventions are necessary to limit the impact of these conditions on people’s health and quality of life.
PC101 offered a practical and acceptable tool to help expand the scope of practice of non-physician clinicians to include NCD care, but we were not able to show improvements in care, as we have previously done for communicable diseases.
The study illustrates the limitations of trials designed to study the effects of complex system interventions in real life, where even small changes across many endpoints, as seen in our study, may be useful to decision-makers under pressure to respond constructively to the rise of multimorbidity and NCDs.
PC101 has been adopted for country-wide implementation in primary care clinics in South Africa.