Multicentre Cluster-randomised Controlled Trial Research Articles

Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI − 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI − 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (− 10.2%, 95% CI − 6.01 to − 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

The effectiveness of motivational interviewing on adherence to wearing orthopedic shoes in people with diabetes at low-to-high risk of foot ulceration: A multicenter cluster-randomized controlled trial

AimTo evaluate the effectiveness of motivational interviewing (MI) performed by MI-trained podiatrists in improving adherence to wearing orthopedic shoes in comparison to usual care in people with diabetes at low-to-high risk of ulceration. MethodsPeople with diabetes with loss of protective sensation and/or peripheral artery disease, and with orthopedic shoes prescription were allocated to receive one MI-consultation by a podiatrist randomized to MI training (n = 53) or usual care only (n = 68). Adherence was measured as the percentage of steps taken while wearing orthopedic shoes, determined using an insole temperature microsensor and wrist-worn activity tracker during one week at 3 and 6 months. ResultsThe proportion of participants ≥80 % adherent to wearing their orthopedic shoes was higher in the control group than in the MI-intervention group at 3 months (30.9 % versus 15.1 %; p = 0.044), and not significantly different at 6 months (22.1 % versus 13.2 %; p = 0.210). Average adherence was also higher in the control group than the intervention group at both 3 months (60.9 % versus 50.9 %; p = 0.029) and 6 months (59.9 % versus 49.5 %; p = 0.025). ConclusionsOne podiatrist-led MI-consultation in its current form did not result in higher adherence to wearing orthopedic shoes in people with diabetes 3 and 6 months after inclusion.Trial registration: Netherlands Trial Register NL7710 (available on the International Clinical Trials Registry Platform).

Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial

Introduction: Effective non-pharmacological treatment options for depression in older adults are lacking. Objective: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated. Methods: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up. Results: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = −2.77, 95% CI = −4.19 to −1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42–1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = −1.53, 95% CI = −2.81 to −0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07–0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = −0.89 (−2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = −0.82 to 0.24). Conclusions: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up.

Cost-Effectiveness of Inter-Professional Collaboration to Reduce Hospitalisations in Nursing Home Residents: Results from the German Interprof ACT Trial.

The German multi-centre cluster-randomised controlled trial interprof ACT investigated interventions to increase inter-professional collaboration between nursing home (NH) staff and local general practitioners to reduce hospitalisations and improve nursing homes residents' (NHRs) quality of life. The trial was funded by the German Health Care Innovation Fund. Cost-effectiveness of interprof ACT interventions was evaluated and compared to current standard of care (SOC) over 12 months, including 622 NHRs in 34 NHs in Germany. Multiplying resource use of healthcare services with German-specific unit costs generated costs. Health outcome was measured in quality-adjusted life-years QALYs), utility by multiplying EQ-5D-5L values with German-specific utility weights. Incremental cost-effectiveness analysis used an intention-to-treat approach and scenario analyses (SAs). Net-benefit-regression and cost-effectiveness acceptability curves addressed uncertainty. A German healthcare insurance perspective was assumed. Base case results showed non-significant cost savings of 851.88€ and non-significant QALY loss of -0,056. Dependency levels at baseline were non-significantly higher in IG compared to control group (CG). Lack of baseline costing data eliminated possibility to evaluate changes in costs due to the interprof ACT measures for both groups. Interprof ACT interventions are not cost-effective compared to current SOC.

Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial

BackgroundVertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care.MethodsFor this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design.DiscussionWith our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care.Trial registrationDRKS, DRKS00028524 retrospectively registered on March 24, 2022.

Social Network and Participation in Elderly Primary Care Patients in Germany and Associations with Depressive Symptoms-A Cross-Sectional Analysis from the AgeWell.de Study.

This study aims to describe social network and social participation and to assess associations with depressive symptoms in older persons with increased risk for dementia in Germany. We conducted a cross-sectional observational study in primary care patients (aged 60–77) as part of a multicenter cluster-randomized controlled trial (AgeWell.de). We present descriptive and multivariate analyses for social networks (Lubben Social Network Scale and subscales) and social participation (item list of social activities) and analyze associations of these variables with depressive symptoms (Geriatric Depression Scale). Of 1030 included patients, 17.2% were at risk for social isolation (Lubben Social Network Scale < 12). Looking at the subscales, a reduced non-family network was found almost twice as often as a reduced family network. Patients with depressive symptoms had significantly smaller social networks than patients without depression (p < 0.001). They rather engaged in social activities of low involvement level or no weekly social activity at all (p < 0.001). The study shows associations of depressive symptoms with a decreased social network and less social participation in elderly participants. Sufficient non-family contacts and weekly social activities seem to play an important role in mental health and should be encouraged in elderly primary care patients.

Colorectal Cancer: Performance and Evaluation for CT Colonography Screening- A Multicenter Cluster-randomized Controlled Trial.

Background Most radiologists reporting CT colonography (CTC) do not undergo compulsory performance accreditation, potentially lowering diagnostic sensitivity. Purpose To determine whether 1-day individualized training in CTC reporting improves diagnostic sensitivity of experienced radiologists for 6-mm or larger lesions, the durability of any improvement, and any associated factors. Materials and Methods This prospective, multicenter cluster-randomized controlled trial was performed in National Health Service hospitals in England and Wales between April 2017 and January 2020. CTC services were cluster randomized into intervention (1-day training plus feedback) or control (no training or feedback) arms. Radiologists in the intervention arm attended a 1-day workshop focusing on CTC reporting pitfalls with individualized feedback. Radiologists in the control group received no training. Sensitivity for 6-mm or larger lesions was tested at baseline and 1, 6, and 12 months thereafter via interpretation of 10 CTC scans at each time point. The primary outcome was the mean difference in per-lesion sensitivity between arms at 1 month, analyzed using multilevel regression after adjustment for baseline sensitivity. Secondary outcomes included per-lesion sensitivity at 6- and 12-month follow-up, sensitivity for flat neoplasia, and effect of prior CTC experience. Results A total of 69 hospitals were randomly assigned to the intervention (31 clusters, 80 radiologists) or control (38 clusters, 59 radiologists) arm. Radiologists were experienced (median, 500-999 CTC scans interpreted) and reported CTC scans routinely (median, 151-200 scans per year). One-month sensitivity improved after intervention (66.4% [659 of 992]) compared with sensitivity in the control group (42.4% [278 of 655]; difference = 20.8%; 95% CI: 14.6, 27.0; P < .001). Improvements were maintained at 6 (66.4% [572 of 861] vs 50.5% [283 of 560]; difference = 13.0%; 95% CI: 7.4, 18.5; P < .001) and 12 (63.7% [310 of 487] vs 44.4% [187 of 421]; difference = 16.7%; 95% CI: 10.3, 23.1; P < .001) months. This beneficial effect applied to flat lesions (difference = 22.7%; 95% CI: 15.5, 29.9; P < .001) and was independent of career experience (≥1500 CTC scans: odds ratio = 1.09; 95% CI: 0.88, 1.36; P = .22). Conclusion For radiologists evaluating CT colonography studies, a 1-day training intervention yielded sustained improvement in detection of clinically relevant colorectal neoplasia, independent of previous career experience. Clinical trial registration no. NCT02892721 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Pickhardt in this issue. An earlier incorrect version appeared online and in print. This article was corrected on February 28, 2022.

Facilitators and barriers to implementation of Alberta family integrated care (FICare) in level II neonatal intensive care units: a qualitative process evaluation substudy of a multicentre cluster-randomised controlled trial using the consolidated framework for implementation research

ObjectiveTo evaluate the barriers and facilitators to implementing Alberta Family Integrated Care (AB-FICare [2019 Benzies]), a model of care for integrating parents into level II neonatal intensive care units (NICUs)...

Decision support for computed tomography in the emergency department: a multicenter cluster-randomized controlled trial.

Clinical decision support may facilitate evidence-based imaging, but most studies to date examining the impact of decision support have used non-randomized designs which limit the conclusions that can be drawn from them. This randomized trial examines if decision support can reduce computed tomography (CT) utilization for patients with mild traumatic brain injuries and suspected pulmonary embolism in the emergency department. This study was funded by a competitive public research grant and registered on ClinicalTrials.gov (NCT02410941). Emergency physicians at five urban sites were assigned to voluntary decision support for CT imaging of patients with either head injuries or suspected pulmonary embolism using a cluster-randomized design over a 1-year intervention period. The co-primary outcomes were CT head and CT pulmonary angiography utilization. CT pulmonary angiography diagnostic yield (proportion of studies diagnostic for acute pulmonary embolism) was a secondary outcome. A total of 225 physicians were randomized and studied over a 2-year baseline and 1-year intervention period. Physicians interacted with the decision support in 38.0% and 45.0% of eligible head injury and suspected pulmonary embolism cases, respectively. A mixed effects logistic regression model demonstrated no significant impact of decision support on head CT utilization (OR 0.93, 95% CI 0.79-1.10, p = 0.31), CT pulmonary angiography utilization (OR 0.98, 95% CI 0.88-1.11, p = 0.74) or diagnostic yield (OR 1.23, 95% CI 0.96-1.65, p = 0.10). However, overall CT pulmonary diagnostic yield (17.7%) was almost three times higher than that reported by a recent large US study, suggesting that selective imaging was already being employed. Voluntary decision support addressing many commonly cited barriers to evidence-based imaging did not significantly reduce CT utilization or improve diagnostic yield but was limited by low rates of participation and high baseline rates of selective imaging. Demonstrating value to clinicians through interventions that improve workflow is likely necessary to meaningfully change imaging practices.

The effect of a hand hygiene intervention on infections in residents of nursing homes: a cluster randomized controlled trial

BackgroundThe primary goal of hand hygiene is to reduce infectious disease rates. We examined if a nursing home’s participation in a hand hygiene intervention resulted in residents having fewer healthcare associated infections (HAIs) when compared to nursing homes without the hand hygiene intervention.MethodsThis study is a part of a cluster randomized controlled trial (RCT) in 33 nursing homes to improve hand hygiene (HANDSOME). The incidence of five illnesses was followed over 13 months: gastroenteritis, influenza-like illness, pneumonia, urinary tract infections and infections from methicillin-resistant Staphylococcus aureus (MRSA). Incidence rates per study arm were reported for baseline (October–December 2016) and two follow-up periods (January–April 2017, May–October 2017). HAI rates were compared in a Poisson multilevel analysis, correcting for baseline differences (the baseline infection incidence and the size of the nursing home), clustering of observations within nursing homes, and period in the study.ResultsThere was statistically significantly more gastroenteritis (p < 0.001) and statistically significantly less influenza-like illness (p < 0.01) in the intervention arm when compared to the control arm. There were no statistically significant differences or pneumonia, urinary tract infections, and MRSA infections in the intervention arm when compared to the control arm. In a sensitivity analysis, gastroenteritis was no longer statistically significantly higher in the intervention arm (p = 0.92).ConclusionsAs in comparable studies, we could not conclusively demonstrate the effectiveness of an HH intervention in reducing HAIs among residents of nursing homes, despite the use of clearly defined outcome measures, a standardized reporting instrument, and directly observed HH in a multicenter cluster RCT. Trial registration Netherlands Trial Register, trial NL6049 (NTR6188). Registered October 25, 2016, https://www.trialregister.nl/trial/6049.

Early recognition and response to increases in surgical site infections using optimized statistical process control charts\u2014the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design

BackgroundSurgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance.MethodsThe Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8–9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone.DiscussionThe traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the “signal” is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial.Trial registrationClinicalTrials.govNCT03075813, Registered March 9, 2017.

Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study)

IntroductionAdherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term...

Abstract 149: Double Sequential External Defibrillation in Refractory Ventricular Fibrillation: The Dose VF Pilot Randomized Controlled Trial

Background: Despite significant advances in resuscitation efforts, there are some patients who remain in ventricular fibrillation (VF) after multiple defibrillation attempts during out-of-hospital cardiac arrest (OHCA). Double sequential external defibrillation (DSED) and vector change defibrillation (VC) have been proposed as alternate therapeutic strategies for OHCA patients in shock-refractory VF. Objective: To determine the feasibility, safety and sample size required for a larger, multicentered, 3-arm, cluster randomized controlled trial (RCT) with 2 crossovers comparing DSED or VC to standard defibrillation (control group) for OHCA patients presenting in shock-refractory VF. Methods: We conducted a pilot cluster randomized controlled trial with crossover including all consecutive treated adult OHCA patients who presented in VF and received a minimum of three successive shocks. In addition to standard cardiac arrest care, each EMS agency was randomly assigned to provide standard defibrillation (control), DSED, or VC, followed by crossover to an alternate defibrillation strategy after 6 months. Results: Prior to the launch of the trial, 2,500 paramedics received in-person training in the techniques of DSED and VC defibrillation using a combination of didactic, video and simulated scenarios. Between March 2018 and June 2019, 113 patients were enrolled in 4 Canadian EMS agencies, with zero missed cases. Monthly enrollment varied from 1 to 6 cases per agency. With respect to feasibility, 96% of cases were compliant with the study protocol, and only five (4.4%) cases received a defibrillation strategy that differed from the allocation schedule. There were no reported cases of defibrillator malfunction, no concerns expressed by paramedics, patients, families, or ED staff about the trial, and no reported cases of skin burns or difficulty with pad placement. Conclusions: Findings from our pilot implementation trial suggest the DOSE VF protocol is feasible and safe. The results of this internal pilot trial will allow us to calculate a sample size for a definitive multicenter cluster RCT with crossovers to determine if these alternate defibrillation strategies for OHCA shock refractory VF will impact patient-centered, clinical outcomes.

The use of a stronger instructional design by implementing repetitive practice in simulation-based obstetric team training: trainees’ satisfaction

ObjectiveThis study compares satisfaction levels from multiprofessional obstetric care teams about simulation-based obstetric team training courses with and without the instructional design feature repetitive practice.MethodsThe present study is part of...

Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185

BackgroundNursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study.Methods/designThis multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level.The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level.The implementation strategy comprises a facilitators’ workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents’ participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents’ quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost–utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation.DiscussionWe expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals.Trial registrationDRKS, DRKS00015185. Registered on 1 August 2018. Universal Trial Number U1111–1218-1555. Registered on 26 July 2018.

Effects of the ‘11+ Kids’ injury prevention programme on severe injuries in children’s football: a secondary analysis of data from a multicentre cluster-randomised controlled trial

BackgroundTo assess the effects of the injury prevention programme ‘11+ Kids’ on reducing severe injuries in 7 to 13 year old football (soccer) players.MethodsFootball clubs (under-9, under-11 and under-13 age...

Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention

ObjectiveThe objective of the study was to compare the total use of healthcare services in the course of the first year after a stroke between participants who, after the acute...

Effectiveness of the blended-care lifestyle intervention \u2018PerfectFit\u2019: a cluster randomised trial in employees at risk for cardiovascular diseases

BackgroundWeb-based lifestyle interventions at the workplace have the potential to promote health and work productivity. However, the sustainability of effects is often small, which could be enhanced by adding face-to-face contacts, so-called ‘blended care’. Therefore, this study evaluates the effects of a blended workplace health promotion intervention on health and work outcomes among employees with increased cardiovascular risk.MethodsIn this multicentre cluster-randomised controlled trial (PerfectFit), 491 workers in 18 work units from military, police, and a hospital with increased cardiovascular risk were randomised into two intervention groups. The limited intervention (n = 213; 9 clusters) consisted of a web-based Health Risk Assessment with advice. In the extensive intervention (n = 271; 8 clusters), coaching sessions by occupational health physicians using motivational interviewing were added. One cluster dropped out after randomisation but before any inclusion of subjects. Primary outcome was self-rated health. Secondary outcomes were body weight, body mass index (BMI), work productivity, and health behaviours. Follow-up measurements were collected at 6 and 12 months. Effect sizes were determined in mixed effects models.ResultsAt 12 months, the extensive intervention was not statistically different from the limited intervention for self-rated health (4.3%; 95%CI -5.3-12.8), BMI (− 0.81; 95%CI -1.87-0.26) and body weight (− 2.16; 95%CI -5.49-1.17). The within-group analysis showed that in the extensive intervention group body weight (− 3.1 kg; 95% CI -2.0 to − 4.3) was statistically significantly reduced, whereas body weight remained stable in the limited intervention group (+ 0.2 kg; 95% CI -1.4 to 1.8). In both randomised groups productivity loss and physical activity increased and excessive alcohol use decreased significantly at 12 months.ConclusionsThere were no effects on self-rated health, body weight, and BMI. However, within the group with web-based tailored Health Risk Assessment including personalized advice body weight reduced significantly. Adding motivational coaching is promising to reduce body weight.Trial registrationRetrospectively registered at the Netherlands Trial Registry with number NTR4894, at Nov 14 2014.

Effect of an endoscopic quality improvement program on adenoma detection rates: a multicenter cluster-randomized controlled trial in a clinical practice setting (EQUIP-3)

Colonoscopy is protective against colorectal cancer, but its quality and protective benefits can vary. Adenoma detection rate (ADR) is associated with quality and the degree of protection against colorectal cancer and death. In a previous, single academic center, randomized, controlled trial, we demonstrated that anendoscopicquality improvement program increased ADR (EQUIP-1) and that those increases were durable(EQUIP-2). We hypothesized that EQUIP training would increase ADR in a multicenter clinical practice setting. Nine large clinical practice sites were recruited. After a baseline period (phase I), 5 sites were randomized to receive supplemental in-person EQUIP training with active feedback. After follow-up (phase II), the changes in ADRs at these sites were compared with the changes at 4 control sites that did not receive training or feedback until after study completion. Twenty-two thousand three hundred sixteen colonoscopies were included. There was a statistically significant increase in ADR at the training sites (odds ratio [OR], 1.28; P= .004) with a raw ADR of 31% in phase I and 42% in phase II after the intervention. However, raw ADRs also increased at the control sites (from 36% to 39%). As a result, there was limited evidence of a training effect (OR, 1.03; 95% confidence interval [CI], 0.84-1.25; P= .78). ADRs increased at the sites participating in the endoscopic quality improvement program. Howeverit is not clear to what extent the training program is responsible for the changes, because raw ADRsalso increased at the control sites but to a lesser extent. (Clinical Trials Registration number: NCT02325635.).

Implementation of a fire-prevention injury prevention briefing in children's centres: a multicentre cluster-randomised controlled trial

BackgroundEngland has high morbidity and mortality from house fires, with steep social gradients for child deaths: 106 people were admitted to hospital in 2012–13, and 44 deaths between 2008 and 2012 were in children under 5 years old. We developed an evidence-based fire-prevention intervention for use in children's centres comprising an injury prevention briefing (IPB), training, and facilitation for IPB implementation. MethodsWe conducted a multicentre cluster-randomised controlled trial, with a nested qualitative study, in four English study sites. Parents who were at least 16 years old with a child younger than 3 years were recruited from children's centres in disadvantaged areas. Once 30 parent participants were recruited at each centre, centres were stratified by trial site, randomly allocated within strata to one of three arms by an independent statistician using randomisation algorithm in Stata with permuted block randomisation and block size of three: IPB plus facilitation (IPB+), IPB only, and usual care (control). Training (month 0) and facilitation were provided for centres allocated IPB+ at months 1, 3, and 8. Both intervention arms completed follow-up interviews at 12 months. The primary outcome was the proportion of families reporting a fire-escape plan. 11 centres per arm were required to detect an absolute difference of 20% or more in families with fire-escape plans in either intervention arm compared with control (80% power, 5% significance level, intraclass correlation (ICC)=0·05), assuming responses from 20 families per centre. Treatment arms were compared by use of multilevel models to account for clustering by centre. Ethics approval was given by Derbyshire ethics committee (11/EM/0011). Written informed consent was obtained from individual parents and children's centres. This trial is registered with ClinicalTrials.gov, NCT01452191. Findings1112 parents at 36 centres were recruited (373 IPB+, 369 IPB only, 370 control). At 12 months 751 (68%) parents (241 IPB+, 252 IPB only, 258 control) were followed up. Possession of a fire-escape plan was reported by 120 (51%) IPB+ participants, 108 (44%) IPB only, and 119 (47%) controls. There was no significant effect on family possession of fire-escape plans (IPB+ vs control odds ratio 1·41, 95% CI 0·91–2·20; IPB only vs control 0·93, 0·58–1·49 [ICC=0·003]). No adverse events were reported. InterpretationThe IPB, training, and facilitation did not increase parents' possession of fire-escape plans. Both the difficulties faced by children's centres in delivering the intervention to participating families and the secondary outcomes help to explain this outcome. Further research is required to explore both enhancement of penetration of interventions, such as the IPB, to disadvantaged communities and what single item questions about fire escape plans actually measure. FundingNational Institute for Health Research under its Programme Grants for Applied Research programme (RP-PG-0407-10231).