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

Abstract

BackgroundHealth system strengthening is needed to improve delivery of secondary prophylaxis against rheumatic heart disease.Methods and ResultsWe 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).ConclusionsThis 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: http://www.anzctr.org.au. Unique identifier: ACTRN12613000223730.

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

“…During the transition and intensive phases of the trial (15 months), 252 action items were proposed for implementation by healthcare providers 4. Of these, 109 (43%) were completed (Tables 2 and 3, Figure 4).…”

“…NT Aboriginal community clinics were invited to participate; 10 sites (sites A–J) consented, providing 304 clients 4. The required sample size was 300 clients 3.…”

“…Project officers presented clinics with quarterly data in simple graphics at face‐to‐face workshops throughout the intensive phase. To reach improved targets, each clinic developed and implemented a set of activities or action items 3, 4. Action items were compiled into action plans , aligned with the streams of the CCM, that would help the clinic to deliver the penicillin injections more effectively.…”

“…Key findings from the RHDSP trial, reported in detail elsewhere,4 indicated that there was high variation in delivery of penicillin prophylaxis for ARF and/or RHD between sites, and the intervention did not improve penicillin adherence; in fact, adherence was slightly lower during the intensive phase of the trial (126/304 [41%] receiving the target of ≥80% of scheduled injections) compared with baseline (141/304 [46%], not a statistically significant difference). Adherence at baseline was already better than expected at 46%, compared with ≈23% previously (M. Fittock, Registered Nurse, NT RHD Control Program, unpublished data, 2011).…”

“…To improve delivery of ARF/RHD secondary prophylaxis, a comprehensive health‐system–strengthening strategy was developed and evaluated in a stepped‐wedge, community, randomized trial in 10 sites in Australia's NT between 2013 and 2016 (RHDSP [Rheumatic Heart Disease Secondary Prophylaxis] trial) 3, 4. The trial was powered to detect doubling of the proportion of clients getting ≥80% of scheduled penicillin injections from 20% to 40%.…”