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

Abstract

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.

Fig. 1

Study design demonstrating the stepped-wedge process. The stepped-wedge design involves the sequential roll-out of an intervention over periods of time; by study completion, all participating health centres will have received the intervention, for a 15-month period

Fig. 2

Programme theory. The programme theory (or project strategy) uses the six themes of the Chronic Care Model (health system, delivery system design, decision support, clinical information systems, self-management support and community supports) as the scaffold for activities to implement within the study intervention. A cascade of potential outcomes arising from these activities is shown, ultimately leading to increased adherence and thence, reduction in acute rheumatic fever recurrence rates

Fig. 3

Evaluation framework. The central panel of this summarised schematic of the theory-driven evaluation framework illustrates the interplay between implementation (delivery of the intervention to clients, intervention (the agents of change that affect determinants), determinants (change mechanisms) and outcomes (improved adherence). Underpinning theories shown in the right hand panel are action theory (the intervention’s power to affect determinants), and conceptual theory (the determinant’s ability to affect outcomes). External moderators to be accounted for (the environment, organisation factors and team factors) are shown in the left hand panel