scholarly journals ‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052238
Author(s):  
Bharati Kulkarni ◽  
Little Flower Augustine ◽  
Raghu Pullakhandam ◽  
Anju Sinha Pradhan ◽  
Teena Dasi ◽  
...  
Keyword(s):  
Rural Areas ◽  
Randomised Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Population Mean ◽  
Cluster Randomised ◽  
The Difference ◽  
The Impact

IntroductionCurrent anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population.Methods and analysisAn open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering.Ethics and disseminationThe study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders.Trial registration numberCTRI/2019/01/016918.

scholarly journals Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036416
Author(s):  
Laura Green ◽  
Jahnavi Daru ◽  
Julie Dodds ◽  
Francisco Jose Gonzalez Carreras ◽  
Doris Lanz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Postpartum Haemorrhage ◽  
Randomised Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Primary Objective ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Advisory Group ◽  
Cluster Randomised

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.

scholarly journals Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Samantha Keogh ◽  
Caroline Shelverton ◽  
Julie Flynn ◽  
Gabor Mihala ◽  
Saira Mathew ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Control Period ◽  
Randomised Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

scholarly journals Effectiveness of a home fortification programme with multiple micronutrients on infant and young child development: a cluster-randomised trial in rural Bihar, India

2018 ◽  
Vol 120 (2) ◽  
pp. 176-187 ◽  
Author(s):  
Leila M. Larson ◽  
Melissa F. Young ◽  
Patricia J. Bauer ◽  
Rukshan Mehta ◽  
Amy Webb Girard ◽  
...  
Keyword(s):  
Executive Function ◽  
Child Development ◽  
Randomised Trial ◽  
Intervention Group ◽  
Mental Development ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Nutrition Counselling ◽  
Cluster Randomised ◽  
Home Fortification

AbstractResearch demonstrates the importance of nutrition for early brain development. Few studies have examined the effectiveness of multiple micronutrient powders (MNP) on child development. This study examined the impacts of home fortification with MNP on motor and mental development, executive function and memory of children living in Bihar. This two-arm cluster-randomised effectiveness trial selected seventy health sub-centres to receive either MNP and nutrition counselling (intervention) or nutrition counselling alone (control) for 12 months. Front-line health workers delivered the intervention to all households in study communities with a child aged 6–18 months. Data were collected using cross-sectional surveys at baseline and endline by selecting households from intervention (baseline,n2184; endline,n2170) and control (baseline,n2176; endline,n2122) communities using a two-stage cluster-randomised sampling strategy. Children in the intervention group had a significantly larger improvement from baseline to endline compared with those in the control group on scores for motor and mental development (Cohen’sd, motor=0·12; 95 % CI 0·03, 0·22; mental=0·15; 95 % CI 0·06, 0·25). Greater impacts of MNP on motor and mental development were observed in children from households with higher stimulation scores at baseline compared with those with lower stimulation (Cohen’sd, motor=0·20v. 0·09; mental=0·22v. 0·14;Pinteraction<0·05). No significant treatment differences were seen for executive function or memory. Home fortification with MNP through the existing health infrastructure in Bihar was effective in improving motor and mental development and should be considered in combination with other child development interventions such as stimulation.

scholarly journals Effectiveness and cost-utility of a multifaceted eHealth strategy to improve back pain beliefs of patients with non-specific low back pain: a cluster randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e030879 ◽  
Author(s):  
Arnela Suman ◽  
Frederieke G. Schaafsma ◽  
Johanna M. van Dongen ◽  
Petra J.M. Elders ◽  
Rachelle Buchbinder ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cost Utility ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Low Back ◽  
Pain Beliefs ◽  
Cluster Randomised

ObjectivesTo assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients’ back pain beliefs, and in decreasing disability and absenteeism.DesignStepped-wedge cluster randomised trial with parallel economic evaluation.SettingDutch primary healthcare.ParticipantsPatients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).InterventionsThe intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.Primary and secondary outcome measuresThe primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.ResultsThere were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70— and the societal cost difference was €535—in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).ConclusionsA multifaceted eHealth strategy was not effective in improving patients’ back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.Trial registration numberNTR4329.

Analysis of self-efficacy for stroke recognition and action from a cluster randomised trial evaluating the effects of stroke education pamphlets versus a 12-minute culturally tailored stroke film among Black and Hispanic churchgoers in New York

2021 ◽  
pp. 001789692110028
Author(s):  
Daudet Ilunga Tshiswaka ◽  
Jeanne Teresi ◽  
Joseph P. Eimicke ◽  
Jian Kong ◽  
James M. Noble ◽  
...  
Keyword(s):  
New York ◽  
Usual Care ◽  
Self Efficacy ◽  
Retention Rate ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact

Background: Because early recognition of symptoms and timely treatment of stroke can reduce mortality and the long-term effects of such events, efforts to make many people both aware of these symptoms and knowledgeable about what to do when recognising them are critical for reducing impacts from stroke. Objectives: To assess the impact of a stroke preparedness film (intervention) and stroke preparedness pamphlets (usual care) on self-efficacy for stroke recognition and action. Design: Two-arm cluster randomised trial conducted between July 2013 and August 2018. Setting: A total of 13 church sites located in economically disadvantaged urban neighbourhoods in New York. Of the 883 churchgoers approached, 503 expressed interest, 375 completed eligibility screening and 312 were randomised. Participant inclusion criteria were Black or Hispanic churchgoers, aged 34 years or older, without stroke history, but at a high risk for stroke. The intervention consisted of two 12-minute stroke films: Gospel of Stroke, in English for Black participants, and Derrame Cerebral, in Spanish for Hispanic participants. Method: Participants were pre–post-tested (at baseline, 6-month follow-up and 12-month follow-up) for self-efficacy. Descriptive analysis, a linear mixed model and t tests were used to assess the effects of a stroke preparedness film and stroke preparedness pamphlets on self-efficacy. Results: Findings are based on intention-to-treat analysis. A total of 310 participants completed the study (99% retention rate). About half (53.8%) of participants were Black and 46.2% Hispanic in the intervention group; 48.3% were Black and 51.7% were Hispanic in the usual care group. Overall, both groups evidenced higher self-efficacy (i.e. lower predicted means) over time ( p < .0001), although a significant benefit was not observed for the intervention relative to usual care. Conclusion: Both stroke preparedness films and stroke preparedness pamphlets improved self-efficacy with respect to stroke recognition and action among minority churchgoers.

Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial

2021 ◽  
pp. oemed-2020-106794
Author(s):  
Luise Moelenberg Begtrup ◽  
Per Malmros ◽  
Charlotte Brauer ◽  
Sandra Soegaard Toettenborg ◽  
Esben Meulengracht Flachs ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Term Pregnancy ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
Work Units

ObjectiveThe aim was to test if targeting managers with an educational intervention reduces absence among pregnant employees.MethodsThe study was a non-blinded cluster randomised trial conducted in hospitals and daycare institutions from two administrative Danish Regions and two Danish municipalities. Clusters (work units) were assigned randomly and non-blinded to either (1) intervention, where all managers were invited to participate in a 3-hour seminar addressing needs and options for adjustment of work in pregnancy, or (2) control, with practice as usual. The primary outcome based on payroll data was long-term pregnancy-related absence, defined as ≥12.5% cumulated absence during pregnancy weeks 1–32. Intention-to-treat analysis was applied using mixed logistic regression.ResultsNinety work units were included (56 hospital departments and 34 daycare units) with 451 pregnant employees in the intervention group and 464 in the control group. Work units had on average 11 pregnant employees with no difference between the groups. 103 of the 216 invited managers (48%) participated in a the 3-hour seminar. In the intervention group, 154 (34%) had long-term pregnancy-related absence during pregnancy weeks 1–32 vs 166 (36%) in the control group. Relative odds of having long-term pregnancy-related absence, when being in the intervention group, was 1.06 (95% CI 0.71 to 1.58), with an interclass correlation coefficient of 0.07.ConclusionAn educational intervention targeting managers did not reduce pregnancy-related absence among pregnant employees.Trial registration numberNCT03002987.

scholarly journals Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033842 ◽  
Author(s):  
Xiaochang Zhang ◽  
Xiao Hu ◽  
Jixiang Ma ◽  
Puhong Zhang ◽  
Yuan Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Cluster Randomised ◽  
The Difference ◽  
Randomised Controlled

IntroductionSalt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.Methods and analysisA cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.Trial registration numberChiCTR1800016804.

scholarly journals Effectiveness of a kindergarten-based intervention to increase vegetable intake and reduce food neophobia amongst 1-year-old children: a cluster randomised controlled trial

2021 ◽  
Author(s):  
Eli Anne Myrvoll Blomkvist ◽  
Andrew K. Wills ◽  
Sissel Heidi Helland ◽  
Elisabet Rudjord Hillesund ◽  
Nina Cecilie Øverby
Keyword(s):  
Vegetable Intake ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Post Intervention ◽  
Food Neophobia ◽  
Cluster Randomised ◽  
Group 2

Background: Children’s first years of life are crucial to their future health. Studies show that a varied diet with a high intake of vegetables is positive in several domains of health. The present low vegetable intake amongst children is, therefore, a concern. Food neophobia is a common barrier to vegetable intake in children. As most Norwegian children attend kindergarten from an early age, kindergartens could contribute to the prevention of food neophobia and the promotion of vegetable intake. Objective: The aim of this study was to assess the effect of a cluster randomised trial amongst 1-year-old children in kindergarten to reduce food neophobia and promote healthy eating. Methods: Kindergartens were randomly allocated to either a control group or one of two intervention groups. Both intervention groups (diet and diet + Sapere-method) were served a warm lunch meal including three alternating intervention vegetables, whilst the intervention group 2 (diet + Sapere) in addition received tools for weekly sensory lessons. The intervention was digitally administered via information and recipes on a study website. The control group did not receive any information. Parents completed digitally distributed questionnaires addressing food neophobia and food habits at baseline and post-intervention. Results: The parents of 144 1-year-old children in 46 kindergartens completed the questionnaires, which were included in the main analysis. The results suggested a higher intake of the intervention vegetables in group 2 (diet + Sapere) compared to the control group. The effect on total vegetable intake was inconclusive. No effect was observed on the level of food neophobia in either of the intervention group. Conclusion: This digitally delivered dietary and sensory intervention promoted the intake of intervention-targeted vegetables with inconclusive effect on total vegetable intake due to large loss to follow-up. No effect on the level of food neophobia was detected.

scholarly journals The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047210
Author(s):  
Anurag Bhargava ◽  
Madhavi Bhargava ◽  
Banurekha Velayutham ◽  
Kannan Thiruvengadam ◽  
Basilea Watson ◽  
...  
Keyword(s):  
Risk Factor ◽  
Nutritional Status ◽  
G Proteins ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Household Contacts ◽  
Cluster Randomised ◽  
High Prevalence ◽  
Secondary Outcomes ◽  
The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

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