scholarly journals Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. Part I: Primary outcome of a cluster randomised trial

2011 ◽  
Vol 48 (9) ◽  
pp. 1040-1048 ◽  
Author(s):  
Betsie G.I. van Gaal ◽  
Lisette Schoonhoven ◽  
Joke A.J. Mintjes ◽  
George F. Borm ◽  
Marlies E.J.L. Hulscher ◽  
...  
Keyword(s):  
Nursing Homes ◽  
Adverse Events ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes

BMJ Open ◽  
2013 ◽  
Vol 3 (1) ◽  
pp. e002072 ◽  
Author(s):  
Lee-Fay Low ◽  
Henry Brodaty ◽  
Belinda Goodenough ◽  
Peter Spitzer ◽  
Jean-Paul Bell ◽  
...  
Keyword(s):  
Nursing Homes ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: A cluster randomised trial

2010 ◽  
Vol 47 (9) ◽  
pp. 1117-1125 ◽  
Author(s):  
Betsie G.I. van Gaal ◽  
Lisette Schoonhoven ◽  
Lilian C.M. Vloet ◽  
Joke A.J. Mintjes ◽  
George F. Borm ◽  
...  
Keyword(s):  
Patient Safety ◽  
Nursing Homes ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Safety Knowledge

scholarly journals Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101634
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Muhammad Ahmar Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Public Health ◽  
Primary Outcome ◽  
Clinical Care ◽  
Randomised Trial ◽  
Health Facilities ◽  
Cluster Randomised Trial ◽  
Public Healthcare ◽  
Public Health Facilities ◽  
Cluster Randomised

BackgroundIn Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice.AimTo assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation.Design & settingA two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014–December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up.MethodFacilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded.ResultsSix-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention–control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001).ConclusionThe findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.

scholarly journals Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (5) ◽  
pp. e1003608
Author(s):  
Pitchaya P. Indravudh ◽  
Katherine Fielding ◽  
Moses K. Kumwenda ◽  
Rebecca Nzawa ◽  
Richard Chilongosi ◽  
...  
Keyword(s):  
Older Adults ◽  
Hiv Testing ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Hiv Treatment ◽  
Cluster Randomised Trial ◽  
Post Intervention ◽  
Art Initiation ◽  
Cluster Randomised ◽  
Self Testing

Background Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). Methods and findings This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI −36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. Conclusions In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. Trial registration Clinicaltrials.gov NCT03541382.

scholarly journals Effects of an electronic software ‘prompt’ with healthcare professional training on cardiovascular and renal complications in a multi-ethnic population with Type 2 Diabetes and Microalbuminuria (The GP Prompt study): results of a pragmatic cluster randomised trial.

2020 ◽  
Author(s):  
Andrew Willis ◽  
Winston Crasto ◽  
Laura J Gray ◽  
Helen Dallosso ◽  
Ghazala Waheed ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Cardiovascular Risk ◽  
Odds Ratio ◽  
Cardiovascular Events ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

<b>Background:</b> Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. <p><b>Methods:</b> A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy.</p> <p><b>Results:</b> 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]).</p> <p><b>Conclusions:</b> Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.</p> <p><b> </b></p>

Completeness of assisted bathing in nursing homes related to dementia and bathing method: results from a secondary analysis of cluster-randomised trial data

2015 ◽  
Vol 11 (2) ◽  
pp. 121-129 ◽  
Author(s):  
Theo van Achterberg ◽  
Betsie G.I. van Gaal ◽  
Wytske W. Geense ◽  
Geert Verbeke ◽  
Carine van der Vleuten ◽  
...  
Keyword(s):  
Nursing Homes ◽  
Randomised Trial ◽  
Secondary Analysis ◽  
Trial Data ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals Effects of an electronic software ‘prompt’ with healthcare professional training on cardiovascular and renal complications in a multi-ethnic population with Type 2 Diabetes and Microalbuminuria (The GP Prompt study): results of a pragmatic cluster randomised trial.

2020 ◽  
Author(s):  
Andrew Willis ◽  
Winston Crasto ◽  
Laura J Gray ◽  
Helen Dallosso ◽  
Ghazala Waheed ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Cardiovascular Risk ◽  
Odds Ratio ◽  
Cardiovascular Events ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

<b>Background:</b> Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. <p><b>Methods:</b> A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy.</p> <p><b>Results:</b> 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]).</p> <p><b>Conclusions:</b> Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.</p> <p><b> </b></p>

scholarly journals Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028694
Author(s):  
Christopher W Jones ◽  
Amanda Adams ◽  
Mark A Weaver ◽  
Sara Schroter ◽  
Benjamin S Misemer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Peer Review ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Selective Outcome Reporting ◽  
Outcome Reporting ◽  
Cluster Randomised ◽  
Peer Reviewers

IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study’s trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

scholarly journals Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033640 ◽  
Author(s):  
R I Helou ◽  
Gaud Catho ◽  
Annabel Peyravi Latif ◽  
Johan Mouton ◽  
M Hulscher ◽  
...  
Keyword(s):  
Antimicrobial Stewardship ◽  
Professional Training ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Great Promise ◽  
Antimicrobial Use ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
The Impact

IntroductionWith the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.Methods and analysisUse of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.Ethics and disseminationThis protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberClinicalTrials.gov registry (NCT03793946). Stage; pre-results.

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