scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
Kunuz Haji Bedru ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Safe Motherhood ◽  
Link Type ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.

scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Manisha A. Kulkarni ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Jimma Zone ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Ethiopia in 2016 reported doing so at a health facility. Maternity waiting homes (MWHs) have been introduced to overcome geographical and financial barriers to institutional births but there is no conclusive evidence as to their effectiveness. We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. Methods A parallel, three-arm, stratified, cluster-randomized controlled trial design is being employed to evaluate intervention effects on institutional births, which is the primary outcome. Trial arms are: (1) upgraded MWH + religious/community leader training; (2) leader training alone; and (3) standard care. Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round. Outcome assessments will be made using repeat cross-sectional surveys at baseline and 24 months postintervention. An intention to treat approach will be used and the primary outcome analysed using generalized linear mixed models with a random effect for cluster and time. A cost-effectiveness analysis will also be conducted from a societal perspective. Discussion This is one of the first trials to evaluate the effectiveness of upgraded MWHs and will provide much needed evidence to policy makers about aspects of functionality and the community engagement required as they scale-up this programme in Ethiopia. Trial registration ClinicalTrial.gov, NCT03299491. Retrospectively registered on 3 October 2017.

scholarly journals Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand

BMJ ◽  
2020 ◽  
pp. m3797 ◽  
Author(s):  
Justin S White ◽  
Christopher Lowenstein ◽  
Nucharee Srivirojana ◽  
Aree Jampaklay ◽  
William H Dow
Keyword(s):  
Usual Care ◽  
Text Messaging ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Monetary Incentive ◽  
Care Group ◽  
Smoking Abstinence ◽  
Open Label ◽  
Intention To Treat ◽  
Cluster Randomized

Abstract Objective To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country. Design Parallel group, open label, assessor blinded, cluster randomized controlled trial. Setting Large industrial workplaces in metropolitan Bangkok, Thailand. Participants Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies). Interventions Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40). Main outcome measures The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers. Results Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval −2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; −3.2 points, −6.6 to −0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other. Conclusions Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings. Trial registration ClinicalTrials.gov ( NCT02421224 ).

scholarly journals The effectiveness of a psycho-education intervention on mental health literacy in communities affected by the COVID-19 pandemic—a cluster randomized trial of 24 villages in central Uganda—a research protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dickens Akena ◽  
Ronald Kiguba ◽  
Wilson W. Muhwezi ◽  
Brendan Kwesiga ◽  
Gwendolyne Kigozi ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Health Literacy ◽  
Randomized Trial ◽  
Mental Health Literacy ◽  
Cluster Randomized Trial ◽  
Stress Disorders ◽  
Education Intervention ◽  
Link Type ◽  
Cluster Randomized

Abstract Background Literature shows a high prevalence of psychological distress (PD) as well as common mental disorders (CMD) such as major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD), and substance misuse disorders (SUD) among people exposed to disasters and pandemics like the COVID-19. Moreover, CMD are associated with increased mortality (mainly through suicide) and morbidity (loss of productivity). A number of countries have made deliberate efforts to identify and manage CMD in light of COVID-19. However, low levels of mental health literacy (MHL) manifested by the individual’s unawareness of CMD symptoms, limited human and mental health infrastructure resources, and high levels of mental illness stigma (MIS) are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19. Objectives For the proposed study, we will determine effectiveness of a psycho-education intervention delivered by village health team (VHT) members. Methods We will employ a cluster randomized trial design in 24 villages in central Uganda. We will collect baseline data to and document the prevalence of MHL, PD, MDD, PTSD, GAD, and SUD. We will distribute information education and communication materials (IEC) aimed at improving MHL to 420 adult individuals in the intervention arm (n = 12 villages). In the control arm (n = 12 villages), VHTs will distribute ministry of health COVID-19 information leaflets to 420 participants. Within 7 days of distributing the materials, research assistants will conduct a follow-up interview and assess for the same parameters (MHL, PD, MDD, PTSD, GAD, and SUD). We will use an intention to treat analysis to estimate the effectiveness of the psycho-education intervention. Discussion Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response. Trial registration ClinicalTrials.govNCT04616989. Registered on 05 November 2020

scholarly journals Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Nimer Ortuno-Gutierrez ◽  
Assoumani Younoussa ◽  
Andriamira Randrianantoandro ◽  
Sofie Braet ◽  
Bertrand Cauchoix ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Link Type ◽  
High Incidence ◽  
Leprosy Patients ◽  
Household Members ◽  
Cluster Randomized ◽  
Exposure Prophylaxis

Abstract Background Leprosy is an ancient infectious disease with a global annual incidence that has plateaued above 200,000 new cases since over a decade. New strategies are required to overcome this stalemate. Post-exposure prophylaxis (PEP) with a single dose of Rifampicin (SDR) has conditionally been recommended by the World Health Organization (WHO), based on a randomized-controlled-trial in Bangladesh. More evidence is required. The Post ExpOsure Prophylaxis for Leprosy (PEOPLE) trial will assess effectiveness of different modalities of PEP on the Comoros and Madagascar. Methods PEOPLE is a cluster-randomized trial with villages selected on previous leprosy-incidence and randomly allocated to four arms. Four annual door-to-door surveys will be performed in all arms. All consenting permanent residents will be screened for leprosy. Leprosy patients will be treated according to international guidelines and eligible contacts will be provided with SDR-PEP. Arm-1 is the comparator in which no PEP will be provided. In arms 2, 3 and 4, SDR-PEP will be provided at double the regular dose (20 mg/kg) to eligible contacts aged two years and above. In arm 2 all household-members of incident leprosy patients are eligible. In arm 3 not only household-members but also neighbourhood contacts living within 100-m of an incident case are eligible. In arm 4 such neighbourhood contacts are only eligible if they test positive to anti-PGL-I, a serological marker. Incidence rate ratios calculated between the comparator arm 1 and each of the intervention arms will constitute the primary outcome. Discussion Different trials on PEP have yielded varying results. The pivotal COLEP trial in Bangladesh showed a 57% reduction in incidence over a two-year period post-intervention without any rebound in the following years. A study in a high-incidence setting in Indonesia showed no effect of PEP provided to close contacts but a major effect of PEP provided as a blanket measure to an entire island population. High background incidence could be the reason of the lack of effect of PEP provided to individual contacts. The PEOPLE trial will assess effectiveness of PEP in a high incidence setting and will compare three different approaches, to identify who benefits most from PEP. Trial registration Clinicaltrials.Gov. NCT03662022. Initial Protocol Version 1.2, 27-Aug-2018.

Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial

2021 ◽  
pp. ASN.2020091254
Author(s):  
Navdeep Tangri ◽  
Amit X. Garg ◽  
Thomas W. Ferguson ◽  
Stephanie Dixon ◽  
Claudio Rigatto ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Randomized Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Dialysis Initiation ◽  
Secondary Outcome ◽  
Control Group ◽  
Inpatient Setting ◽  
Link Type ◽  
Cluster Randomized

BackgroundThe Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise.MethodsTo evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting.ResultsThe analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient.ConclusionsA multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics.Clinical Trial registry name and registration number:ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987

Influential methods reports for group-randomized trials and related designs

2022 ◽  
pp. 174077452110634
Author(s):  
David M Murray
Keyword(s):  
Randomized Trial ◽  
Group Treatment ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Group Randomized Trials ◽  
Randomized Controlled ◽  
Relative Citation ◽  
Group Randomized Trial ◽  
Cluster Randomized

Background. This article identifies the most influential methods reports for group-randomized trials and related designs published through 2020. Many interventions are delivered to participants in real or virtual groups or in groups defined by a shared interventionist so that there is an expectation for positive correlation among observations taken on participants in the same group. These interventions are typically evaluated using a group- or cluster-randomized trial, an individually randomized group treatment trial, or a stepped wedge group- or cluster-randomized trial. These trials face methodological issues beyond those encountered in the more familiar individually randomized controlled trial. Methods. PubMed was searched to identify candidate methods reports; that search was supplemented by reports known to the author. Candidate reports were reviewed by the author to include only those focused on the designs of interest. Citation counts and the relative citation ratio, a new bibliometric tool developed at the National Institutes of Health, were used to identify influential reports. The relative citation ratio measures influence at the article level by comparing the citation rate of the reference article to the citation rates of the articles cited by other articles that also cite the reference article. Results. In total, 1043 reports were identified that were published through 2020. However, 55 were deemed to be the most influential based on their relative citation ratio or their citation count using criteria specific to each of the three designs, with 32 group-randomized trial reports, 7 individually randomized group treatment trial reports, and 16 stepped wedge group-randomized trial reports. Many of the influential reports were early publications that drew attention to the issues that distinguish these designs from the more familiar individually randomized controlled trial. Others were textbooks that covered a wide range of issues for these designs. Others were “first reports” on analytic methods appropriate for a specific type of data (e.g. binary data, ordinal data), for features commonly encountered in these studies (e.g. unequal cluster size, attrition), or for important variations in study design (e.g. repeated measures, cohort versus cross-section). Many presented methods for sample size calculations. Others described how these designs could be applied to a new area (e.g. dissemination and implementation research). Among the reports with the highest relative citation ratios were the CONSORT statements for each design. Conclusions. Collectively, the influential reports address topics of great interest to investigators who might consider using one of these designs and need guidance on selecting the most appropriate design for their research question and on the best methods for design, analysis, and sample size.

scholarly journals Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial

2020 ◽  
Vol 41 (30) ◽  
pp. 2836-2844 ◽  
Author(s):  
Carline J van den Dries ◽  
Sander van Doorn ◽  
Frans H Rutten ◽  
Ruud Oudega ◽  
Sjef J C M van de Leur ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Usual Care ◽  
Randomized Trial ◽  
Integrated Care ◽  
Cluster Randomized Trial ◽  
Easy Access ◽  
Care Intervention ◽  
All Cause Mortality ◽  
Cluster Randomized

Abstract Aims To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care. Methods and results The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72–83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37–0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27–0.82). For other adverse events, no statistically significant differences were observed. Conclusion In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

scholarly journals A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease

2020 ◽  
Author(s):  
Oriol Mitja ◽  
Maria Ubals ◽  
Marc Corbacho ◽  
Andrea Alemany ◽  
Clara Suner ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Primary Outcome ◽  
Cluster Randomized Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Definitive Evidence ◽  
Beneficial Effects ◽  
Significant Difference ◽  
Cluster Randomized

Background Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are limited to non-pharmacological interventions. Hydroxychloroquine (HCQ) has been proposed as a postexposure therapy to prevent Coronavirus disease 2019 (Covid-19) but definitive evidence is lacking. Methods We conducted an open-label, cluster-randomized trial including asymptomatic contacts exposed to a PCR-positive Covid-19 case in Catalonia, Spain. Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). The primary outcome was PCR-confirmed symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, either symptomatically compatible or a PCR-positive result regardless of symptoms. Adverse events (AEs) were assessed up to 28 days. Results The analysis included 2,314 healthy contacts of 672 Covid-19 index cases identified between Mar 17 and Apr 28, 2020. A total of 1,198 were randomly allocated to usual care and 1,116 to HCQ therapy. There was no significant difference in the primary outcome of PCR-confirmed, symptomatic Covid-19 disease (6.2% usual care vs. 5.7% HCQ; risk ratio 0.89 [95% confidence interval 0.54-1.46]), nor evidence of beneficial effects on prevention of SARS-CoV-2 transmission (17.8% usual care vs. 18.7% HCQ). The incidence of AEs was higher in the intervention arm than in the control arm (5.9% usual care vs 51.6% HCQ), but no treatment-related serious AEs were reported. Conclusions Postexposure therapy with HCQ did not prevent SARS-CoV-2 disease and infection in healthy individuals exposed to a PCR-positive case. Our findings do not support HCQ as postexposure prophylaxis for Covid-19.

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