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Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of community health workers (CHWs) in Neno district, Malawi to better support the care needs of the clients they serve. The proposed intervention is a 'Household Model' where CHWs will be reassigned to households, rather than to specific patients with HIV and/or tuberculosis (TB). METHODS AND ANALYSIS:Using a stepped-wedge, cluster-randomised design, this study investigates whether high HIV retention rates can be replicated for non-communicable diseases (NCDs), and the model's impact on TB and paediatric malnutrition case finding, as well as the uptake of family planning and antenatal care. Eleven sites (health centres and hospitals) were arranged into six clusters (average cluster population 21?800). Primary outcomes include retention in care for HIV and chronic NCDs, TB case finding, paediatric malnutrition case finding, and utilisation of early and complete antenatal care. Clinical outcomes are based on routinely collected data from the Ministry of Health's District Health Information System 2 and an OpenMRS electronic medical record supported by Partners In Health. Additionally, semistructured qualitative interviews with various stakeholders will assess community perceptions and context of the Household Model. ETHICS AND DISSEMINATION:Ethics approval has been obtained from the Malawian National Health Science Research Committee (#16/11/1694) in Lilongwe, Malawi; Partners Healthcare Human Research Committee (#2017P000548/PHS) in Somerville, Massachusetts; and the Biomedical and Scientific Research Ethics Sub-Committee (REGO-2017-2060) at the University of Warwick in Coventry, UK. Dissemination will include manuscripts for peer-reviewed publication as well as a full report detailing the findings of the intervention for the Malawian Ministry of Health. TRIAL REGISTRATION NUMBER:NCT03106727. PRIMARY SPONSOR:Partners In Health | Abwenzi Pa Za Umoyo P.O. Box 56, Neno, Malawi. Protocol Version 4, March 2018.

SUBMITTER: Dunbar EL

PROVIDER: S-EPMC6089278 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial.

Dunbar Elizabeth L EL Wroe Emily B EB Nhlema Basimenye B Kachimanga Chiyembekezo C Gupta Ravi R Taylor Celia C Michaelis Annie A Cundale Katie K Dullie Luckson L Jumbe Arnold A Nazimera Lawrence L McBain Ryan R Lilford Richard J RJ Watson Samuel Ian SI

BMJ open 20180713 7

<h4>Introduction</h4>This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of community health workers (CHWs) in Neno district, Malawi to better support the care needs of the clients they serve. The proposed intervention is a 'Household Model' where CHWs will be reassigned to households, rather than to specific patients with HIV and/or tuberculosis (TB).<h4>Methods and analysis</h4>Using a stepped-wedge, cluster-randomised design, this ...[more]

PMID: 30007924

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Project description:BACKGROUND:By 2015, Malawi had not achieved Millennium Development Goal 4, reducing maternal mortality by about 35% from 675 to 439 deaths per 100,000 livebirths. Hypothesised reasons included low uptake of antenatal care (ANC), intrapartum care, and postnatal care. Involving community health workers (CHWs) in identification of pregnant women and linking them to perinatal services is a key strategy to reinforce uptake of perinatal care in Neno, Malawi. We evaluated changes in uptake after deployment of CHWs between March 2014 and June 2016. METHODS:A CHW intervention was implemented in Neno District, Malawi in a designated catchment area of about 3100 women of childbearing age. The pre-intervention period was March 2014 to February 2015, and the post-intervention period was March 2015 to June 2016. A 5-day maternal health training package was delivered to 211 paid and supervised CHWs. CHWs were deployed to identify pregnant women and escort them to perinatal care visits. A synthetic control method, in which a "counterfactual site" was created from six available control facilities in Neno District, was used to evaluate the intervention. Outcomes of interest included uptake of first-time ANC, ANC within the first trimester, four or more ANC visits, intrapartum care, and postnatal care follow-up. RESULTS:Women enrolled in ANC increased by 18% (95% Credible Interval (CrI): 8, 29%) from an average of 83 to 98 per month, the proportion of pregnant women starting ANC in the first trimester increased by 200% (95% CrI: 162, 234%) from 10 to 29% per month, the proportion of women completing four or more ANC visits increased by 37% (95% CrI: 31, 43%) from 28 to 39%, and monthly utilisation of intrapartum care increased by 20% (95% CrI: 13, 28%) from 85 to 102 women per month. There was little evidence that the CHW intervention changed utilisation of postnatal care (- 37, 95% CrI: - 224, 170%). CONCLUSIONS:In a rural district in Malawi, uptake of ANC and intrapartum care increased considerably following an intervention using CHWs to identify pregnant women and link them to care.

Project description:Background: Non-communicable diseases (NCDs) are a leading cause of worldwide morbidity and mortality, yet access to care in lower-income countries is limited. Rural communities, where poverty levels are high, feel the greatest burden. In Malawi, as elsewhere in the African region, it is particularly challenging for patients in rural districts to obtain care for locally endemic and severe NCDs such as type 1 diabetes, rheumatic heart disease, and sickle cell disease. The Package of Essential NCD Interventions – Plus (PEN-Plus) is a strategy to decentralize care for these severe conditions by enabling local clinicians at intermediate-care facilities to provide services otherwise available only through specialty clinics at central hospitals. Objectives: The primary objective of this study was to evaluate the impact of training mid-level providers to treat severe and chronic NCDs in newly established PEN-Plus clinics in Neno, Malawi. Methods: Our team developed a logic model to describe the anticipated impacts of the intervention on provider knowledge, patient recruitment, and care provision. We applied a retrospective review of routinely collected clinical and administrative data to assess changes along these hypothesized pathways. Findings: Didactic trainings improved provider test scores immediately following training (25-point improvement; p < 0.01), with demonstrated retention of knowledge after 6 months (21-point improvement, p < 0.01). Over 350 patients were enrolled in the first 18 months of program initiation. The PEN-Plus clinic led to significant improvement in the provision of medications and testing across a range of services. Conclusion: Mid-level providers can be successfully trained to treat severe NCDs with physician-guided education, mentorship, and supervision. The PEN-Plus clinic improved patient enrollment, the quality of clinical care and access to essential medications and laboratory supplies. These lessons learned can guide decentralization of NCD care to district hospitals in Malawi and expansion of PEN-Plus services in the African region.

Project description:BackgroundMalawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.MethodsWe will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.DiscussionThis study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.Trial registrationClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

Project description:OBJECTIVES:There is emerging interest and data supporting the effectiveness of community health workers (CHWs) in non-communicable diseases (NCDs) in low/middle-income countries (LMICs). This study aimed to determine whether a CHW-led intervention targeting diabetes and hypertension could improve markers of clinical disease control in rural Mexico. DESIGN AND SETTING:A prospective observational stepped-wedge study was conducted across seven communities in rural Chiapas, Mexico from March 2014 to April 2018. PARTICIPANTS:149 adults with hypertension and/or diabetes. INTERVENTION:This study was conducted in the context of the programmatic roll-out of an accompaniment-based CHW-led intervention designed to complement comprehensive primary care for adults with diabetes and/or hypertension. Implementation occurred sequentially at 3-month intervals with point-of-care data collected at baseline and every 3?months thereafter for 12 months following roll-out in all communities. OUTCOME MEASURES:Primary outcomes were glycated haemoglobin (HbA1c) and systolic blood pressure (SBP), overall and stratified by baseline disease control. We conducted an individual-level analysis using mixed effects regression, adjusting for time, cohort and clustering at the individual and community levels. RESULTS:Among patients with diabetes, the CHW-led intervention was associated with a decrease in HbA1c of 0.35%; however, CIs were wide (95%?CI -0.90% to 0.20%). In patients with hypertension, there was a 4.7?mm Hg decrease in SBP (95%?CI -8.9 to -0.6). In diabetic patients with HbA1c ?9%, HbA1c decreased by 0.96% (95% CI -1.69% to -0.23%), and in patients with uncontrolled hypertension, SBP decreased by 10.2?mm Hg (95%?CI -17.7 to -2.8). CONCLUSIONS:We found that a CHW-led intervention resulted in clinically meaningful improvement in disease markers for patients with diabetes and hypertension, most apparent among patients with hypertension and patients with uncontrolled disease at baseline. These findings suggest that CHWs can play a valuable role in supporting NCD management in LMICs. TRIAL REGISTRATION NUMBER:NCT02549495.

Project description:BackgroundHigh levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care.MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192.FindingsBetween March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81-1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56-2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70-2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites.InterpretationA supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies.FundingGovernment of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Project description:BackgroundMelioidosis, 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 findingsFrom 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/significanceClear 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 registrationThis trial is registered with ClinicalTrials.gov, number NCT02089152.

Project description:IntroductionThere is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk.Methods and analysisThis stepped-wedge cluster randomised controlled trial will test two hypotheses: (1) VHA medical centres randomised to facilitation for not meeting the targeted case review rate will achieve lower opioid-related serious adverse events (SAEs), relative to facilities not randomised to facilitation and (2) Patients whose cases are required to be reviewed will have a lower rate of opioid-related SAEs compared with comparable risk patients whose cases are not required to be reviewed. Patients who receive an opioid prescription at VHA medical centres will be followed for a minimum of 3 months after their first opioid prescription. Follow-up will continue until the last day of the project or death. The data will be analysed using an intention-to-treat approach with patient-month-level Cox proportional hazards models for both interventions.Ethics and disseminationEvaluation of the randomised roll-out was approved by the VA Boston Healthcare System Institutional Review Board (IRB) and Research & Development Committees (Protocol # 3069). Findings will be published in peer-reviewed journals and presentations at national conference meetings.Trial registration numberISRCTN16012111.

Project description:ObjectiveThis study aimed to investigate the effectiveness of workplace active rest programme (WARP) on chronic low back pain (LBP) among office workers.DesignA closed cohort, stepped-wedge cluster randomised trial was conducted. The total duration of the study was 16 weeks (4 weeks for each step). Sequence allocation was randomised, but no one was blinded.SettingThis study was conducted in three offices in a Japanese electronics company. One office was for the administrative department, the others are for the engineering department.ParticipantsWe recruited 29 office workers with LBP greater than 3 months. LBP due to specific injury or disease was excluded. The median age was 38 years, and 26 (90%) were male. All participants completed the study.InterventionsIn the intervention phase, participants performed WARP comprising frequent stand-up and individualised brief exercise/physical activity during work. Physical therapists held an LBP workshop and developed tailor-made programmes before introducing WARP. We instructed participants to perform WARP at five timings during work. Control phase was set before the intervention and participants stayed as usual.Primary and secondary outcome measuresThe primary outcome was pain intensity of LBP assessed using the Brief Pain Inventory. The secondary outcomes were work productivity loss measured using the Work Limitations Questionnaire, LBP disability assessed using the Roland-Morris Disability Questionnaire, psychosocial subscale assessed using the STarT Back Screening Tool and physical activity measured using triaxial accelerometers. These outcomes were collected at baseline and at 4-month follow-up evaluation.ResultsIn the intention-to-treat analysis, WARP did not show any significant effects on pain intensity (β, 0.01; 95% CI -0.50 to 0.52) and on the secondary outcomes. The median adherence to WARP was 28.6% (IQR, 16.8-41.1), which was equal to 1.43 times per day. No adverse effect was observed.ConclusionsThe present study was unable to confirm the effectiveness of active rest in improving LBP. Hence, further study needs to investigate its effectiveness.Trial registration numberUMIN000033210.

Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Dataset Information

Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial.

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Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial.

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