Effectiveness of a multifaceted prevention programme for melioidosis in diabetics (PREMEL): A stepped-wedge
Pornpan Suntornsut1, Prapit Teparrukkul2, Gumphol Wongsuvan1
1Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Background:
Melioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.
Methodology/Principal Findings:
From April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46-1.99, p = 0.66).
Conclusions/Significance:
Clear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed.
Trial Registration:
This trial is registered with ClinicalTrials.gov, number NCT02089152.
Insights
A prevention program for melioidosis in diabetics in Thailand showed no significant reduction in melioidosis cases. However, adherence to the program was linked to fewer infectious disease hospitalizations and lower mortality rates.
Area of Science:
- Infectious Diseases
- Public Health
- Tropical Medicine
Background:
- Melioidosis, a fatal infectious disease caused by Burkholderia pseudomallei, is prevalent in tropical regions.
- Diabetes mellitus and environmental exposure are key risk factors for melioidosis.
- Northeast Thailand has a high incidence of melioidosis among diabetic patients.
Purpose of the Study:
- To evaluate the effectiveness of a multifaceted prevention program for melioidosis in diabetic patients in northeast Thailand.
- To assess the impact of behavioral support on reducing melioidosis incidence and related hospitalizations.
Main Methods:
- A stepped-wedge cluster-randomized controlled trial was conducted in 116 primary care units from April 2014 to December 2018.
- The intervention involved behavioral support group sessions promoting protective behaviors like wearing rubber boots and drinking boiled water.
- Outcomes included hospital admissions for infectious diseases and culture-confirmed melioidosis, with yearly follow-ups for 9,056 diabetic patients.
Main Results:
- The intention-to-treat analysis showed no significant association between the intervention and primary outcomes.
- Per-protocol analysis indicated lower incidence rates of infectious disease hospitalizations (IRR 0.89) and all-cause mortality (IRR 0.54) among patients receiving the intervention.
- However, the incidence rate of culture-confirmed melioidosis was not significantly reduced (IRR 0.96).
Conclusions:
- The multifaceted prevention program did not demonstrate clear benefits in reducing melioidosis incidence.
- Improved patient engagement, modified behavior change techniques, and increased intervention frequency may be necessary for greater effectiveness.
- While not reducing melioidosis directly, the intervention showed promise in lowering infectious disease hospitalizations and mortality in diabetic patients.
