Prescriber and Patient-Oriented Behavioural Interventions to Improve Use of Malaria Rapid Diagnostic Tests in Tanzania: Facility-Based Cluster Randomised Trial

"In a geographical area where previously in some areas over 90% of patients who were prescribed an antimalarial did not have malaria, this study has demonstrated that a combination of prescriber and patient behavioural interventions can, by incremental steps, take this down close to zero."

Affordable and reliable rapid diagnostic tests for malaria (RDTs) are a potentially important tool to address a public health problem - the overdiagnosis of malaria in febrile patients in Africa and Asia - yet overprescription of antimalarials even when test results are negative persists. With this background, and noting that the reasons for overprescription (and neglect of non-malaria causes of fever) depend on prescriber perceptions including of patient expectations, researchers from the ACT Consortium carried out the Targeting Artemisinin Combination Trial (TACT). This 3-arm stratified cluster-randomised trial was conducted between September 2010 and March 2012 in 36 primary care facilities (clusters) within 2 predominately rural districts where malaria transmission has been declining, Muheza in the Tanga region and Moshi Rural in the Kilimanjaro region, in northeast Tanzania. The goal was to study prescriber and patient-oriented behavioural interventions to improve adherence to national and World Health Organization (WHO) malaria diagnosis and treatment guidelines and to improve case management of non-malarial fever.

The design of interventions was guided by formative mixed-methods research that took an evidence-based approach to a design comprising 5 key stages: 1) focus group discussions and in-depth interviews with health workers and community members to understand the existing scenario of malaria diagnosis and antimalarial use; 2) a review of evidence and engagement in behaviour change theory to guide choice of intervention strategies; 3) a structured project workshop to bring together findings from previous stages into a draft outline of intervention activities and key messages; 4) design of the intervention materials; and 5) piloting and pre-testing of the intervention materials.

Specifically, the 3 arms of the trial were: 1) the standard training arm (termed control); 2) the health worker (HW) intervention arm; and 3) the health worker plus patient-oriented (HWP) intervention arm. The final multi-level intervention targeting individual prescribers at the trial facilities as well as their interaction with patients included: small group workshops, feedback and motivational mobile-phone text messages (SMS) to all prescribers in the intervention facilities and patient leaflets and clinic posters to the HWP facilities (see Table 1 and Figure 2). A total of 44,121 eligible patients, 14,217 in the control arm, 15,931 in the HW arm, and 13,973 in the HWP arm, provided consent to participate in the study from the beginning of the trial are included in the analysis.

In addition to the standard RDT training, prescribers from facilities randomised to the HW and HWP arms received further training through 3 interactive workshops 4 to 6 weeks later. These were of approximately 2 hours with a small group of 4 to 8 prescribing colleagues from neighbouring facilities, led by a group moderator from the project. Workshops followed 3 pre-written modules based on 3 stages of a change process: preparing, experimenting, and consolidating prescribing change. The first module aimed to sensitise prescribers to the TACT trial and the rationale for the change in policy for management of febrile illness in order that individuals and peers consider if and how to change practice. The second module aimed at providing prescribers with confidence when using RDTs - in particular, the capacity to communicate effectively, including negotiating with patients who disagree with the prescribed clinical management. The final module was aimed at sustaining the change in practice by using challenging role-plays to practice integration of RDTs and demonstrate the capacity to problem solve a RDT logistical challenge. The groups were encouraged to share experiences and to work together to identify solutions.

Prescribers in the HWP arm also received a supply of patient leaflets and clinic posters designed to influence prescribers through encouraging demand for RDTs and adherence to results as best practice by patients, following action research with community members and several rounds of pretesting. These were to be displayed and distributed at the facilities for the duration of the trial. Patients were not asked or expected to make any particular response to the prescriber, although the prescriber could use the leaflets to explain their decision making if they wished to do so.

Approximately 5 months after the interactive workshops until the end of the trial, prescribing staff in both intervention arms were sent a series of SMS to reinforce the aims of the workshops; namely, to build prescribers' motivation, skills, and confidence to implement the strategy of RDTs in the realities of their own practice. Initially, they provided a feedback summary to prescribers of their previous month's performance on the use of RDTs (proportion of eligible patients who were tested) and treatment prescribed based on RDT results (proportion of patients with a negative test treated with an antimalarial drug). These were then followed by motivational SMS twice a day over a 15-day period with a message on malaria case management alternated with a motivational proverb.

Standard RDT training reduced pre-trial levels of antimalarial prescribing, which was sustained throughout the trial. Incorrect prescribing of an antimalarial for non-malarial illness was lower in the two intervention arms after the introduction of each component of the intervention package (Table 4). After the introduction of the standard RDT training, prescribing of a recommended antimalarial was low in all arms and there was a trend towards increased benefit of introducing feedback and motivating SMS to reinforce the training that had been received. There did not appear to be a waning of the effect of the standard RDT training.

Both interventions significantly lowered incorrect prescribing of recommended antimalarials from 8% (749/8,942) in the standard training arm to 2% (250/10,118) in the HW arm (adjusted risk difference (aRD) 4%; 95% confidence interval (CI) 1% to 6%; P = 0.008) and 2% (184/10,163) in the HWP arm (aRD 4%; 95% CI 1% to 6%; P = 0.005). The peer group workshops, the feedback SMS and the motivational SMS each appear to have contributed incremental improvements to the point where overuse of antimalarials was nearly eliminated after the maximum intervention was received. The prescriber and prescriber plus patient-oriented interventions significantly reduced the proportion of RDT negative patients receiving an antimalarial from 19% in the control to 6% in the HW arm (aRD = 10%; 95% CI 3% to 17%; P = 0.01) and 4% in the HWP arm (aRD = 10%; 95% CI 4% to 16%; P = 0.002). There was no evidence, however, of a significant increase in the proportion of RDT positive patients receiving an ACT in the intervention arms (80% in the control, 83% in the HW arm (aRD = -13%; 95% CI -45% to 19%), and 77% in HWP arm (aRD = -4%; 95% -25% to 17%)). There was no evidence of a difference in the prescribing of antibiotics between the control and HW arms but there was evidence that the HWP interventions significantly reduced the proportion of patients with non-malarial illness receiving an antibiotic (aRD 0.14; 95% CI -0.01 to 0.29; P = 0.06).

Reflecting on the communication strategies specifically, the researchers note that the small-group training was a strategy that builds on the finding that perceived peer pressure is one of the reasons for malaria misdiagnosis and the observation that change in RDT use has occurred through informal group discussion and experimentation. "Formalising such a process of change requires skilled facilitators and success requires motivated health workers. These elements are often not present in resource poor settings, but our results do suggest that a measurable improvement is possible with only three attendances, which is achievable. As such, peer group training may provide a future model for in-service education beyond malaria case management, and may be useful to employ, for example, as medical practice moves from a scenario of simple guidelines with few diagnostic resources to a scenario where a wider range of diagnoses are considered and supported by more diagnostic resources." Furthermore, the sending of SMS to prescribers appears a low-cost addition. The intervention in which prescribers received patient leaflets and clinic posters as well as the interactive workshops required intensive development and pretesting with end users. Further research would be required to establish the independent effects of each intervention component.

The researchers conclude that small group training with SMS was associated with an incremental and sustained improvement in prescriber adherence to RDT results and reducing over-prescribing of antimalarials to close to zero. "Trials of behavioural interventions often suffer from a lack of sufficient formative qualitative research; a strength of the current study was an in-depth formative period. A novel feature of the trial was targeting prescribers and patients (who may influence prescribers) simultaneously." These types of interventions may become increasingly important to cope with the wider range of diagnostic and treatment options for patients with acute febrile illness in Africa.

The ACT Consortium is funded through a grant from the Bill & Melinda Gates Foundation to the London School of Hygiene & Tropical Medicine.