The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial

Objectives

This study aims to intensively evaluate the effectiveness of mindfulness-based intervention (MBI) on mental illness risks (including psychological distress, prolonged fatigue, and perceived stress) and job strain (job control and job demands) for employees with poor mental health.

Methods

A longitudinal research design was adopted. In total, 144 participants were randomized to the intervention group or the control group. The intervention group participated in MBI for eight weeks. Measurements were collected for both groups at five time points: at pre-intervention (T1), at mid-intervention (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight weeks after intervention (T5). Data were analyzed according to the intention-to-treat principle. A linear mixed model with two levels was employed to analyze the repeated measurement data.

Results

Compared with the control group, the intercepts (means at T3) for the intervention group were significantly lower on psychological distress, prolonged fatigue, and perceived stress when MBI was completed. Even with the demographic variables controlled, the positive effects remained. For growth rates of prolonged fatigue and perceived stress, participants in the intervention group showed a steeper decrease than did the participants in the control group. Regarding job strain, although the intercept (mean at T3) of job demands showed a significant decline when BMI was completed, the significance disappeared when the demographic variables were controlled. Moreover, the other results for job control and job demands did not show promising findings.

Conclusion

As a workplace health promotion program, the MBI seems to have potential in improving mental illness risks for employees with poor mental health. However, there was insufficient evidence to support its effect on mitigating job strain. Further research on maintaining the positive effects on mental health for the long term and on developing innovative MBI to suit job strain are recommended.

Trial Registration

ClinicalTrials.gov NCT02241070     

Workplace Social Capital and Mental Health among Chinese Employees: A Multi-Level,Cross-Sectional Study

Background

Whereas the majority of previous research on social capital and health has been on residential neighborhoods and communities, the evidence remains sparse on workplace social capital. To address this gap in the literature, we examined the association between workplace social capital and health status among Chinese employees in a large, multi-level, cross-sectional study.

Methods

By employing a two-stage stratified random sampling procedure, 2,796 employees were identified from 35 workplaces in Shanghai during March to November 2012. Workplace social capital was assessed using a validated and psychometrically tested eight-item measure, and the Chinese language version of the WHO-Five Well-Being Index (WHO-5) was used to assess mental health. Control variables included sex, age, marital status, education level, occupation status, smoking status, physical activity, and job stress. Multilevel logistic regression analysis was conducted to explore whether individual- and workplace-level social capital was associated with mental health status.

Results

In total, 34.9% of workers reported poor mental health (WHO-5<13). After controlling for individual-level socio-demographic and lifestyle variables, compared to workers with the highest quartile of personal social capital, workers with the third, second, and lowest quartiles exhibited 1.39 to 3.54 times greater odds of poor mental health, 1.39 (95% CI: 1.10–1.75), 1.85 (95% CI: 1.38–2.46) and 3.54 (95% CI: 2.73–4.59), respectively. Corresponding odds ratios for workplace-level social capital were 0.95 (95% CI: 0.61–1.49), 1.14 (95% CI: 0.72–1.81) and 1.63 (95% CI: 1.05–2.53) for the third, second, and lowest quartiles, respectively.

Conclusions

Higher workplace social capital is associated with lower odds of poor mental health among Chinese employees. Promoting social capital at the workplace may contribute to enhancing employees’ mental health in China.     

Evaluation of a mHealth Data Quality Intervention to Improve Documentation of Pregnancy Outcomes by Health Surveillance Assistants in Malawi: A Cluster Randomized Trial

Background

While community health workers are being recognized as an integral work force with growing responsibilities, increased demands can potentially affect motivation and performance. The ubiquity of mobile phones, even in hard-to-reach communities, has facilitated the pursuit of novel approaches to support community health workers beyond traditional modes of supervision, job aids, in-service training, and material compensation. We tested whether supportive short message services (SMS) could improve reporting of pregnancies and pregnancy outcomes among community health workers (Health Surveillance Assistants, or HSAs) in Malawi.

Methods and Findings

We designed a set of one-way SMS that were sent to HSAs on a regular basis during a 12-month period. We tested the effectiveness of the cluster-randomized intervention in improving the complete documentation of a pregnancy. We defined complete documentation as a pregnancy for which a specific outcome was recorded. HSAs in the treatment group received motivational and data quality SMS. HSAs in the control group received only motivational SMS. During baseline and intervention periods, we matched reported pregnancies to reported outcomes to determine if reporting of matched pregnancies differed between groups and by period. The trial is registered as ISCTRN24785657.

Conclusions

Study results show that the mHealth intervention improved the documentation of matched pregnancies in both the treatment (OR 1.31, 95% CI: 1.10–1.55, p<0.01) and control (OR 1.46, 95% CI: 1.11–1.91, p = 0.01) groups relative to the baseline period, despite differences in SMS content between groups. The results should be interpreted with caution given that the study was underpowered. We did not find a statistically significant difference in matched pregnancy documentation between groups during the intervention period (OR 0.94, 95% CI: 0.63–1.38, p = 0.74). mHealth applications have the potential to improve the tracking and data quality of pregnancies and pregnancy outcomes, particularly in low-resource settings.     

Health Extension Workers Improve Tuberculosis Case Detection and Treatment Success in Southern Ethiopia: A Community Randomized Trial

Background

One of the main strategies to control tuberculosis (TB) is to find and treat people with active disease. Unfortunately, the case detection rates remain low in many countries. Thus, we need interventions to find and treat sufficient number of patients to control TB. We investigated whether involving health extension workers (HEWs: trained community health workers) in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia.

Methodology/Principal Finding

We carried out a community-randomized trial in southern Ethiopia from September 2006 to April 2008. Fifty-one kebeles (with a total population of 296, 811) were randomly allocated to intervention and control groups. We trained HEWs in the intervention kebeles on how to identify suspects, collect sputum, and provide directly observed treatment. The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts. Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles. The mean case detection rate was higher in the intervention than in the control kebeles (122.2% vs 69.4%, p<0.001). In addition, more females patients were identified in the intervention kebeles (149.0 vs 91.6, p<0.001). The mean treatment success rate was higher in the intervention than in the control kebeles (89.3% vs 83.1%, p = 0.012) and more for females patients (89.8% vs 81.3%, p = 0.05).

Conclusions/Significance

The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate, possibly because of an improved service access. This could be applied in settings with low health service coverage and a shortage of health workers.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00803322","term_id":"NCT00803322"}}NCT00803322     

Pain Reduction and Financial Incentives to Improve Glucose Monitoring Adherence in a Community Health Center

Self-monitoring of blood glucose is a critical component of diabetes management. However, patients often do not maintain the testing schedule recommended by their healthcare provider. Many barriers to testing have been cited, including cost and pain. We present a small pilot study to explore whether the use of financial incentives and pain-free lancets could improve adherence to glucose testing in a community health center patient population consisting largely of non-English speaking ethnic minorities with low health literacy. The proportion of patients lost to follow-up was 17%, suggesting that a larger scale study is feasible in this type of setting, but we found no preliminary evidence suggesting a positive effect on adherence by either financial incentives or pain-free lancets. Results from this pilot study will guide the design of larger-scale studies to evaluate approaches to overcome the variety of barriers to glucose testing that are present in disadvantaged patient populations.     

Experience of Offering HIV Rapid Testing to At-Risk Patients in Community Health Centers in Eight Chinese Cities

Objective

To explore the feasibility of offering HIV counseling and testing in community health centers (CHCs) and to provide evidence for the HIV/AIDS response in China.

Methods

Forty-two CHCs were selected from the eight cities that participated in the study. Rapid testing was mainly provided to: clients seeking HIV testing and counseling (HTC); outpatients with high-risk behavior of contracting HIV; inpatients and outpatients of key departments. Aggregate administrative data were collected in CHCs and general hospitals and differences between the two categories were compared.

Results

There were 23,609 patients who underwent HIV testing, accounting for 0.37% of all estimated clinic visits at the 42 sites (0.03%–4.35% by site). Overall, positive screening prevalence was 0.41% (95% confidence interval [CI] 0.33%–0.49%, range 0.00%–0.98%), which is higher than in general hospitals (0.17%). The identification efficiency was 0.22% (95% CI: 0.16%–0.27%) in pilot CHCs, 3.5 times higher than in general hospitals (0.06%) (Chi square test = 95.196, p<0.001). The percentage of those receiving confirmatory tests among those who screened positive was slightly lower in CHCs (73.7%) than in general hospitals (80.1%) (Chi-square test = 17.472, p<0.001). Composition of clients mobilized for testing was consistent with the usage of basic public health and medical services in CHCs. The rate of patients testing HIV positive was higher among patients from key CHC departments (0.68%) than among high-risk Voluntary Counseling and Testing (VCT) clients (0.56%), those participating in outreach activities (0.41%), pregnant women (0.05%), and surgical patients (0.00%).

Conclusion

This project demonstrates that providing HIV testing services for patients who exhibit high risk behavior has a high HIV case detection rate and that CHCs have the capacity to integrate HTC into routine work. It provides concrete evidence supporting the involvement of CHCs in the expansion of HIV/AIDS testing and case finding.     

Effect of Workplace Counseling Interventions Launched by Workplace Health Promotion and Tobacco Control Centers in Taiwan: An Evaluation Based on the Ottawa Charter

Workplace health promotion (WHP) is important to prevent work-related diseases, reduce workplace hazards, and improve personal health of the workers. Health promotion projects were launched through the centers of WHP funded by the Taiwan Bureau of Health Promotion since 2003. Hence, the aim of this study is to evaluate the impact of WHP programs intervention from 2003 to 2007. The intervention group consisted of 838 business entities which had ever undergone counseling of the three centers in northern, central, and southern Taiwan from 2003 to 2007. The control group was composed of 1000 business entities randomly selected from the business directories of the Ministry of Economic Affairs, Taiwan. The questionnaire survey included general company profiles and the assessment of workplace health according to the five action areas of the Ottawa Charter for Health Promotion. We have received 447 (53.3%) questionnaires from the intervention group and 97 questionnaires from the control group. The intervention group was more effective in using the external resources and medical consultation, and they had better follow-up rates of the abnormal results of annual health examinations. Compared to the control group, the intervention group had a significantly decreased smoking rate in 246 companies (61.2%) and a reduced second-hand smoke exposure in 323 companies (78.6%) (p<0.001). By means of the intervention of WHP programs, we can enhance the awareness of the enterprises and the employees to improve worksite health and to create a healthy work environment.     

The Bright Side and Dark Side of Workplace Social Capital: Opposing Effects of Gender on Overweight among Japanese Employees

Background

A growing number of studies have sought to examine the health associations of workplace social capital; however, evidence of associations with overweight is sparse. We examined the association between individual perceptions of workplace social capital and overweight among Japanese male and female employees.

Methodology/Principal Findings

We conducted a cross-sectional survey among full-time employees at a company in Osaka prefecture in February 2012. We used an 8-item measure to assess overall and sub-dimensions of workplace social capital, divided into tertiles. Of 1050 employees, 849 responded, and 750 (624 men and 126 women) could be linked to annual health check-up data in the analysis. Binomial logistic regression models were used to calculate odds ratios and 95% confidence intervals for overweight (body mass index: ≥25 kg/m², calculated from measured weight and height) separately for men and women. The prevalence of overweight was 24.5% among men and 14.3% among women. Among men, low levels of bonding and linking social capital in the workplace were associated with a nearly 2-fold risk of overweight compared to high corresponding dimensions of social capital when adjusted for age, sleep hours, physiological distress, and lifestyle. In contrast, among women we found lower overall and linking social capital to be associated with lower odds for overweight even after covariate adjustment. Subsequently, we used multinomial logistic regression analyses to assess the relationships between a 1 standard deviation (SD) decrease in mean social capital and odds of underweight/overweight relative to normal weight. Among men, a 1-SD decrease in overall, bonding, and linking social capital was significantly associated with higher odds of overweight, but not with underweight. Among women, no significant associations were found for either overweight or underweight.

Conclusions/Significance

We found opposite gender relationships between perceived low linking workplace social capital and overweight among Japanese employees.     

Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial

Introduction

Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women''s groups worked to improve local perinatal health.

Methods and Findings

A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women''s groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention.

Conclusions

Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.

Trial registration

Current Controlled Trials ISRCTN96256793 Please see later in the article for the Editors'' Summary     

Health Workforce Equity in Urban Community Health Service of China

Objectives

To reveal the equity of health workforce distribution in urban community health service (CHS), and to provide evidence for further development of community health service in China.

Methods

A community-based, cross-sectional study was conducted in China from September to December 2011. In the study, 190 CHS centers were selected from 10 provinces of China via stratified multistage cluster sampling. Human resources profiles and basic characteristics of each CHS centers were collected. Lorenz curves and Gini Coefficient were used to measure the inequality in the distribution of health workforce in community health service centers by population size and geographical area. Wilcoxon rank test for paired samples was used to analyze the differences in equity between different health indicators.

Results

On average, there were 7.37 health workers, including 3.25 doctors and 2.32 nurses per 10,000 population ratio. Significant differences were found in all indicators across the samples, while Beijing, Shandong and Zhejiang ranked the highest among these provinces. The Gini coefficients for health workers, doctors and nurses per 10,000 population ratio were 0.39, 0.44, and 0.48, respectively. The equity of doctors per 10,000 population ratio (G = 0.39) was better than that of doctors per square kilometer (G = 0.44) (P = 0.005). Among the total 6,573 health workers, 1,755(26.7%) had undergraduate degree or above, 2,722(41.4%)had junior college degree and 215(3.3%) had high school education. Significant inequity was found in the distribution of workers with undergraduate degree or above (G = 0.52), which was worse than that of health works per 10000 population (P<0.001).

Conclusions

Health workforce inequity was found in this study, especially in quality and geographic distribution. These findings suggest a need for more innovative policies to improve health equity in Chinese urban CHS centers.     

The Role of Community and Individuals in the Formation of Social Capital

Because social capital shapes many desirable socioeconomic outcomes, we ask what incentives drive private investments in social capital. We estimate the association between private investments in social capital (outcome variable) and the following explanatory variables: (a) individual-level variables from an optimal investment model, (b) spillovers from group social capital, (c) village income inequality, and (d) market openness. We draw on information from Tsimane’, a native Amazonian society of foragers and farmers in Bolivia, and equate social capital with gifts, help given, and communal labor offered by the household. Age bore an inverted U-shaped and income bore a positive association with social capital, but geographic mobility, wealth, and schooling bore no significant association with social capital. We found strong group-level associations even after instrumenting social capital; the association probably stems from strong kinship ties which tend to blur the line between the group and the individual. Village measures of social capital were positively and significantly associated with private investments in social capital. We found some evidence that village income inequality and market openness were negatively associated with private investments in social capital.     

Quality and Cost of Diabetes Mellitus Care in Community Health Centers in the United States

Objective

To examine variations in the quality and cost of care provided to patients with diabetes mellitus by Community Health Centers (CHCs) compared to other primary care settings.

Research Design and Methods

We used data from the 2005–2008 Medical Expenditure Panel Survey (N = 2,108). We used two dependent variables: quality of care and ambulatory care expenditures. Our primary independent variable was whether the respondent received care in a Community Health Centers (CHCs) or not. We estimated logistic regression models to determine the probability of quality of care, and used generalized linear models with log link and gamma distribution to predict expenditures for CHC users compared to non-users of CHCs, conditional on patients with positive expenditures.

Results

Results showed that variations of quality between CHC users and non-CHC users were not statistically significant. Patients with diabetes mellitus who used CHCs saved payers and individuals approximately $1,656 in ambulatory care costs compared to non-users of CHCs.

Conclusions

These findings suggest an opportunity for policymakers to control costs for diabetes mellitus patients without having a negative impact on quality of care.     

Health on the Web: Randomised Controlled Trial of Online Screening and Brief Alcohol Intervention Delivered in a Workplace Setting

BackgroundAlcohol misuse in England costs around £7.3 billion (US$12.2 billion) annually from lost productivity and absenteeism. Delivering brief alcohol interventions to employees as part of a health check may be acceptable, particularly with online delivery which can provide privacy for this stigmatised behaviour. Research to support this approach is limited and methodologically weak. The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption, delivered in a workplace as part of a health check.ConclusionsThere was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation. Further research is needed on how to engage a larger proportion of employees in screening.

Trial Registration

International Standard Randomised Controlled Trial Number Register ISRCTN50658915     

上海市某区社区卫生服务中心门诊用药合理性评价

利用6个合理用药国际指标以及TOPSIS法,综合分析和评价了2009年上海市某区12所社区卫生服务中心门诊用药状况。12种社区卫生服务中心门诊处方分析显示：平均药费为77.11元/张,平均药物数为2.30种,抗菌药物费用比例为12.02%,针剂费用比例为12.95%,抗菌药物处方比例为26.27%,国家基本药物使用比例为56.45%。根据C _i值分析,社区卫生服务中心的门诊用药基本合理,部分医疗机构门诊用药合理性有待提高。     

A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims

Background

Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims.

Aim

To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming.

Method

In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4) years] were randomized into three arms. One arm received no intervention (n = 68, Group A), the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role) at discharge from hospital (n = 65, Group B), while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C). All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools.

Results

At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005). This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001). There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006), predominantly in relation to disability in family life (p = 0.006) and social life (p = 0.005). However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532), and the intervention also had no effect on post-traumatic stress disorder.

Conclusions

A brief psychological intervention, which included psychological first aid and psychoeducation plus cognitive behavioural therapy that can be provided by non-specialist doctors appeared to reduce psychiatric symptoms and disability after snakebite envenoming, but not depression or post-traumatic stress disorder.

Trial Registration

Sri Lanka Clinical Trials Registry: SLCTR/2011/003     

城市社区与乡镇卫生院医务人员工作倦怠情况分析

目的 分析基层医疗卫生机构中的城市社区卫生服务中心与乡镇卫生院医务人员的工作倦怠情况及影响因素,探讨两类机构中医务人员倦怠的水平差异。方法 采用Maslach职业倦怠普适量表（MBI-GS）对东北某地区城市社区卫生服务中心及乡镇卫生院进行问卷调查。结果 城市社区卫生服务中心医务人员工作倦怠检出率为27.8%,工作倦怠程度影响因素是学历、职称、工资收入和绩效方案合理性。乡镇卫生院工作倦怠检出率为34.1%,倦怠程度主要受性别、工作时间、工作量和工资收入影响。结论 乡镇卫生院较城市社区卫生服务中心医务人员的工作倦怠感严重,应引起有关管理部门的重视并采取相应的干预措施。     

Effectiveness of a Worksite Mindfulness-Related Multi-Component Health Promotion Intervention on Work Engagement and Mental Health: Results of a Randomized Controlled Trial

Objectives

The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness.

Methods

In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129) received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models.

Results

There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference) and subgroups based on baseline work engagement scores showed no significant differences either.

Conclusions

This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months.

Trial registration

Netherlands Trial Register NTR2199     

Cost-Effectiveness of a Community Pharmacist Intervention in Patients with Depression: A Randomized Controlled Trial (PRODEFAR Study)

Background

Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist''s interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care.

Methods

Patients were recruited by general practitioners and randomized to community pharmacist intervention (87) that received an educational intervention and usual care (92). Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs), use of healthcare services and productivity losses were measured at baseline, 3 and 6 months.

Results

There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER) for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP) is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective). From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000.

Conclusion

A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00794196","term_id":"NCT00794196"}}NCT00794196     

Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial

The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT). Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs) with basic instruction (control); RDTs with provider training (provider arm); and RDTs with provider training plus a school-based community intervention (provider-school arm). The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93%) of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm) were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36): stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26) in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19) in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47). Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.

Trial Registration

ClinicalTrials.gov NCT01350752