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.

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 Rojiroti microfinance and child nutrition: a cluster randomised trial

2019 ◽  
Vol 105 (3) ◽  
pp. 229-235 ◽  
Author(s):  
Shalini Ojha ◽  
Lisa Szatkowski ◽  
Ranjeet Sinha ◽  
Gil Yaron ◽  
Andrew Fogarty ◽  
...  
Keyword(s):  
Child Nutrition ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Z Score ◽  
Primary Analysis ◽  
Height Measurement ◽  
Cluster Randomised ◽  
Children Under 5

ObjectiveTo determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.DesignCluster randomised trial.SettingTolas (village communities) in Bihar State.ParticipantsWomen and children under 5 years.InterventionsWith Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.Outcome measuresThe primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.ResultsWe randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (−1.02) versus controls (−1.37; regression coefficient adjusted for clustering β=0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (−2.13 vs −2.37; β=0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β=0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.ConclusionIn marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.Trial registration numberNCT01845545.

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 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.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

Cluster randomised trial of the impact of biosecurity measures on poultry health in backyard flocks

2013 ◽  
Vol 198 (3) ◽  
pp. 649-655 ◽  
Author(s):  
Anne Conan ◽  
Flavie Luce Goutard ◽  
Davun Holl ◽  
Sok Ra ◽  
Aurélia Ponsich ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Backyard Flocks ◽  
The Impact

Abstract 225: A Depression Quality Program and Cardiovascular Disease: Assessing the Impact on Care

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Linda Gordon ◽  
Amanda Malecky ◽  
Andrew Althouse ◽  
Nicole Ansani
Keyword(s):  
Usual Care ◽  
Goal Attainment ◽  
Intervention Group ◽  
Phone Call ◽  
Categorical Variables ◽  
Care Group ◽  
Control Group ◽  
Surrogate Outcome ◽  
The Impact

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.

scholarly journals Secular trend, seasonality and effects of a community-based intervention on neonatal mortality: follow-up of a cluster-randomised trial in Quang Ninh province, Vietnam

2018 ◽  
Vol 72 (9) ◽  
pp. 776-782
Author(s):  
Leif Eriksson ◽  
Nguyen T Nga ◽  
Dinh T Phuong Hoa ◽  
Duong M Duc ◽  
Anna Bergström ◽  
...  
Keyword(s):  
Time Series ◽  
Neonatal Mortality ◽  
Secular Trend ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Neonatal Deaths ◽  
Live Births ◽  
Cluster Randomised ◽  
Quang Ninh

BackgroundLittle is know about whether the effects of community engagement interventions for child survival in low-income and middle-income settings are sustained. Seasonal variation and secular trend may blur the data. Neonatal mortality was reduced in a cluster-randomised trial in Vietnam where laywomen facilitated groups composed of local stakeholders employing a problem-solving approach for 3 years. In this analysis, we aim at disentangling the secular trend, the seasonal variation and the effect of the intervention on neonatal mortality during and after the trial.MethodsIn Quang Ninh province, 44 communes were allocated to intervention and 46 to control. Births and neonatal deaths were assessed in a baseline survey in 2005, monitored during the trial in 2008–2011 and followed up by a survey in 2014. Time series analyses were performed on monthly neonatal mortality data.ResultsThere were 30 187 live births and 480 neonatal deaths. The intervention reduced the neonatal mortality from 19.1 to 11.6 per 1000 live births. The reduction was sustained 3 years after the trial. The control areas reached a similar level at the time of follow-up. Time series decomposition analysis revealed a downward trend in the intervention areas during the trial that was not found in the control areas. Neonatal mortality peaked in the hot and wet summers.ConclusionsA community engagement intervention resulted in a lower neonatal mortality rate that was sustained but not further reduced after the end of the trial. When decomposing time series of neonatal mortality, a clear downward trend was demonstrated in intervention but not in control areas.Trial registration numberISRCTN44599712, Post-results.

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