Aboriginal children and penicillin injections for rheumatic fever: how much of a problem is injection pain?

OBJECTIVE: To explore young Aboriginal people's and clinicians' experiences of injection pain for the 10 years of penicillin injections children are prescribed to prevent rheumatic fever recurrences. METHODS: Aboriginal children on the penicillin regimen and clinicians were purposively recruited from four remote sites in Australia. Semi-structured interviews and participant observations were conducted. Views were synthesised and thematically analysed. RESULTS: A total of 29 Aboriginal children and 59 clinicians were interviewed. Sixteen participants appeared to become accustomed to the injection pain, eight did not find pain an issue, and five found injection pain difficult. A further five believed the injections made them unwell. Patients expressed varying abilities to negotiate with clinicians about the use of pain reduction measures. Clinicians revealed good knowledge of pain reduction measures, but offered them inconsistently. All clinicians found administering the injections distressing. CONCLUSION: Repeated painful procedures in children necessitate well-planned and child-focused care. Current practices are not in line with guidance from the Royal Australasian College of Physicians about effects of repeated painful procedures on children. Initiating the long-term injection regimen for rheumatic fever is a special event requiring expert input. A newly reported finding of a subset of young people feeling unwell after receiving the injection requires further investigation. Implications for public health: Improvement of local and jurisdictional guidelines on use of pain reduction measures for children who have been prescribed repeated painful injections for rheumatic fever is needed.

Improving Delivery of Secondary Prophylaxis for Rheumatic Heart Disease in a High-Burden Setting: Outcome of a Stepped-Wedge, Community, Randomized Trial.

BACKGROUND: Health system strengthening is needed to improve delivery of secondary prophylaxis against rheumatic heart disease. METHODS AND RESULTS: We undertook a stepped-wedge, randomized trial in northern Australia. Five pairs of Indigenous community clinics entered the study at 3-month steps. Study phases comprised a 12 month baseline phase, 3 month transition phase, 12 month intensive phase and a 3- to 12-month maintenance phase. Clinics received a multicomponent intervention supporting activities to improve penicillin delivery, aligned with the chronic care model, with continuous quality-improvement feedback on adherence. The primary outcome was the proportion receiving ≥80% of scheduled penicillin injections. Secondary outcomes included "days at risk" of acute rheumatic fever recurrence related to late penicillin and acute rheumatic fever recurrence rates. Overall, 304 patients requiring prophylaxis were eligible. The proportion receiving ≥80% of scheduled injections during baseline was 141 of 304 (46%)-higher than anticipated. No effect attributable to the study was evident: in the intensive phase, 126 of 304 (41%) received ≥80% of scheduled injections (odds ratio compared with baseline: 0.78; 95% confidence interval, 0.54-1.11). There was modest improvement in the maintenance phase among high-adhering patients (43% received ≥90% of injections versus 30% [baseline] and 28% [intensive], P<0.001). Also, the proportion of days at risk in the whole cohort decreased in the maintenance phase (0.28 versus 0.32 [baseline] and 0.34 [intensive], P=0.001). Acute rheumatic fever recurrence rates did not differ between study sites during the intensive phase and the whole jurisdiction (3.0 versus 3.5 recurrences per 100 patient-years, P=0.65). CONCLUSIONS: This strategy did not improve adherence to rheumatic heart disease secondary prophylaxis within the study time frame. Longer term primary care strengthening strategies are needed. CLINICAL TRIAL REGISTRATION: URL: www.anzctr.org.au. Unique identifier: ACTRN12613000223730.

Qualitative Evaluation of a Complex Intervention to Improve Rheumatic Heart Disease Secondary Prophylaxis.

BACKGROUND: Rheumatic heart disease is a high-burden condition in Australian Aboriginal communities. We evaluated a stepped-wedge, community, randomized trial at 10 Aboriginal communities from 2013 to 2015. A multifaceted intervention was implemented using quality improvement and chronic care model approaches to improve delivery of penicillin prophylaxis for rheumatic heart disease. The trial did not improve penicillin adherence. This mixed-methods evaluation, designed a priori, aimed to determine the association between methodological approaches and outcomes. METHODS AND RESULTS: An evaluation framework was developed to measure the success of project implementation and of the underlying program theory. The program theory posited that penicillin delivery would be improved through activities implemented at clinics that addressed elements of the chronic care model. Qualitative data were derived from interviews with health-center staff, informants, and clients; participant observation; and project officer reports. Quantitative data comprised numbers and types of "action items," which were developed by participating clinic staff with project officers to improve delivery of penicillin injections. Interview data from 121 health-center staff, 22 informants, and 72 clients revealed barriers to achieving the trial's aims, including project-level factors (short trial duration), implementation factors (types of activities implemented), and contextual factors (high staff turnover and the complex sociocultural environment). Insufficient actions were implemented addressing "self-management support" and "community linkage" streams of the chronic care model. Increased momentum was evident in later stages of the study. CONCLUSIONS: The program theory underpinning the study was sound. The limited impact made by the study on adherence was attributable to complex implementation challenges.

A Comprehensive Needs Assessment Tool for Planning RHD Control Programs in Limited Resource Settings.

Rheumatic heart disease (RHD) is an important cause of disability and death in low- and middle-income countries. However, evidence-based interventions have not been implemented systematically in many countries. We present a RHD Needs Assessment Tool (NAT) that can be used at country or regional levels to systematically develop and plan comprehensive RHD control programs and to provide baseline data for program monitoring and evaluation. The RHD NAT follows a mixed-methods approach using quantitative and qualitative data collection instruments. Evidence is mapped to a conceptual model that follows a patient through the natural history of RHD. The NAT has 4 phases: 1) situational assessment; 2) facility-based assessment of epidemiology and health system capacity; 3) patient and provider experience of RHD using ethnographic methods; and 4) intervention planning, including stakeholder mapping and development of a monitoring and evaluation framework. The RHD NAT is designed to paint a comprehensive picture of RHD care in an endemic setting and to identify the major gaps to disseminating and implementing evidence-based interventions.

Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial.

BACKGROUND: Rheumatic heart disease (RHD), caused by acute rheumatic fever (ARF), is a major health problem in Australian Aboriginal communities. Progress in controlling RHD requires improvements in the delivery of secondary prophylaxis, which comprises regular, long-term injections of penicillin for people with ARF/RHD. METHODS/DESIGN: This trial aims to improve uptake of secondary prophylaxis among Aboriginal people with ARF/RHD to reduce progression or worsening of RHD. This is a stepped-wedge, randomised trial in consenting communities in Australia's Northern Territory. Pairs of randomly-chosen clinics from among those consenting enter the study at 3-monthly steps. The intervention to which clinics are randomised comprises a multi-faceted systems-based package, in which clinics are supported to develop and implement strategies to improve penicillin delivery, aligned with elements of the Chronic Care Model. Continuous quality improvement processes will be used, including 3-monthly feedback to clinic staff of adherence rates of their ARF/RHD clients. The primary outcome is the proportion of people with ARF/RHD receiving ≥ 80% of scheduled penicillin injections over a minimum 12-month period. The sample size of 300 ARF/RHD clients across five community clusters will power the study to detect a 20% increase in the proportion of individuals achieving this target, from a worrying low baseline of 20%, to 40 %. Secondary outcomes pertaining to other measures of adherence will be assessed. Within the randomised trial design, a mixed-methods evaluation will be embedded to evaluate the efficiency, effectiveness, impact and relevance, sustainability, process and fidelity, and performance of the intervention. The evaluation will establish any causal link between outcomes and the intervention. The planned study duration is from 2013 to 2016. DISCUSSION: Continuous quality improvement has a strong track record in Australia's Northern Territory, and its use has resulted in modest benefits in a pilot, non-randomised ARF/RHD study. If successful, this new intervention using the Chronic Care Model as a scaffold and evaluated using a well-developed theory-based framework, will provide a practical and transferable approach to ARF/RHD control. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613000223730. Date registered: 25 February 2013.