Multicentre Cluster-randomised Controlled Trial Research Articles

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).

GeliS: An evaluation of a lifestyle intervention programme on exercise and nutritional habits in pregnant women, families, and infants

Growing evidence suggests that lifestyle during pregnancy and in infant's age is considerably influencing maternal and child's health. The aim of the GeliS study (Gesund leben in der Schwangerschaft/Healthy living in pregnancy) is to examine the effect of a lifestyle intervention programme during pregnancy to avoid excessive gestational weight gain and, hence, to reduce pregnancy and obstetric complications as well as the risk of maternal and offspring obesity. Within the programme, a focus is laid on physical activity and nutritional habits of pregnant women, parents and children [1] , [2] . The GeliS study is a multicentre cluster-randomised controlled trial. A total number of 2500 pregnant women will be recruited in ten Bavarian regions. The intervention comprises three structured and individualised counselling sessions on regular physical activity and a healthy diet during pregnancy and one session after delivery. The counselling sessions, given by specifically trained and certified counsellors, are attached to routine pre- and postnatal visits using standardised materials and procedures. Among other topics, an important module of the lifestyle intervention programme is: promotion of physical activity in pregnant women and their infants as well as exercise in mothers and families to stimulate health-enhancing physical activity right from the start. A 5-year follow-up of both mothers and their infants is planned. Pregnancy and the early postnatal phase are not only critical periods for long-term health, but can also be considered as teachable time frames for expectant mothers, fathers and families. Often they are highly motivated to adopt a healthy lifestyle. However, pregnancy-related health problems and lack of time due to work and childcare are obstacles that need to be overcome. The GeliS-intervention has been adapted to the existing routine health care system for pregnant women. If shown to be effective, it could be immediately implemented in routine care.

Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health in The Gambia, Burkina Faso and Benin: study protocol for a randomized controlled trial.

BackgroundIn sub-Saharan Africa, malaria continues to cause over 10,000 maternal deaths and 75,000 to 200,000 infant deaths. Successful control of malaria in pregnancy could save lives of mothers and babies and is an essential part of antenatal care in endemic areas. The primary objective is to determine the protective efficacy of community-scheduled screening and treatment (CSST) using community health workers (CHW) against the primary outcome of prevalence of placental malaria. The secondary objectives are to determine the protective efficacy of CSST on maternal anaemia, maternal peripheral infection, low birth weight, selection of sulfadoxine-pyrimethamine (SP) resistance markers, and on antenatal clinic (ANC) attendance and coverage of intermittent preventive treatment during pregnancy (IPTp-SP).Methods/designThis is a multi-centre cluster-randomised controlled trial involving three countries with varying malaria endemicity; low (The Gambia) versus high transmission (Burkina Faso and Benin), and varying degrees of SP resistance (high in Benin and moderate in Gambia and Burkina Faso). CHW and their related catchment population who are randomised into the intervention arm will receive specific training on community-based case management of malaria in pregnancy. All women in both study arms will be enrolled at their first ANC visits in their second trimester where they will receive their first dose of IPTp-SP. Thereafter, CHW in the intervention arm will perform scheduled monthly screening and treatment in the womens homes. At time of delivery, a placental biopsy will be collected from all women to determine placental malaria. At each contact point, filter paper and blood slides will be collected for detection of malaria infection and SP resistance markers.DiscussionTo reach successful global malaria control, there is an urgent need to access those at greatest risk of malaria infection. The project is designed to develop a low-cost intervention in pregnant women which will have an immediate impact on the malaria burden in resource-limited countries. This will be done by adding to the standard IPTp-SP delivered through the health facilities: an “extension” strategy to the communities in rural areas thus bringing health services closer to where women live.Trial registrationCurrent Controlled Trials: ISRCTN37259296 (5 July 2013), and clinicaltrials.gov: NCT01941264 (10 September 2013).

Effectiveness of collaborative care for depression in Italy. A randomized controlled trial

Trial designThis was a multicenter cluster-randomized controlled trial. ParticipantsA total of 227 patients ≥18 years old with a new onset of depressive symptoms who screened positive on the first two items of the Patient Health Questionnaire-9 (PHQ-9) were recruited by primary care physicians (PCPs) of eight health districts of three Italian regions from September 2009 to June 2011. InterventionPCPs of the intervention group received a specific collaborative care program including 2 days of intensive training, implementation of a stepped care protocol, depression management toolkit and scheduled meetings with a dedicated consultant psychiatrist. ObjectiveThe objective was to determine whether a collaborative care program for depression management in primary care leads to higher remission rate than usual PCP care. OutcomesOutcome was clinical remission as expressed on PHQ-9 <5 at 3 months. RandomizationAn independent researcher used computer-generated randomization to assign involved primary care groups to the two alternative arms. BlindingPCPs and research personnel were not blinded. ResultsThe 223 PCPs enrolled recruited 227 patients (128 in collaborative care arm, 99 in the usual care arm). At 3 months (n=210), the proportion of patients who achieved remission was higher, though the difference was not statistically significant, in the collaborative care group. The effect size was of 0.11. When considering only patients with minor/major depression, collaborative care appeared to be more effective than usual care (P=.015). ConclusionsThe present intervention for managing depression in primary care, designed to be applicable to the Italian context, appears to be effective and feasible.

Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP)

This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis. A total of 1,381 patients aged ≥ 40 years and newly diagnosed with type 2 diabetes were followed up in national registries for 19 years. Clinical follow-up was at 6 and 14 years after diabetes diagnosis. The original 6 year intervention included regular follow-up and individualised goal setting, supported by prompting of doctors, clinical guidelines, feedback and continuing medical education (ClinicalTrials.gov NCT01074762). The registry-based endpoints were: incidence of any diabetes-related endpoint; diabetes-related death; all-cause mortality; myocardial infarction (MI); stroke; peripheral vascular disease; and microvascular disease. At 14 year clinical follow-up, group differences in risk factors from the 6 year follow-up had levelled out, although the prevalence of (micro)albuminuria and level of triacylglycerols were lower in the intervention group. During 19 years of registry-based monitoring, all-cause mortality was not different between the intervention and comparison groups (58.9 vs 62.3 events per 1,000 patient-years, respectively; for structured personal care, HR 0.94, 95% CI 0.83, 1.08, p = 0.40), but a lower risk emerged for fatal and non-fatal MI (27.3 vs 33.5, HR 0.81, 95% CI 0.68, 0.98, p = 0.030) and any diabetes-related endpoint (69.5 vs 82.1, HR 0.83, 95% CI 0.72, 0.97, p = 0.016). These differences persisted after extensive multivariable adjustment. In concert with features such as prompting, feedback, clinical guidelines and continuing medical education, individualisation of goal setting and drug treatment may safely be applied to treat patients newly diagnosed with type 2 diabetes to lower the risk of diabetes complications.

Promoting Thrombolysis in Acute Ischemic Stroke

Thrombolysis with intravenous recombinant tissue plasminogen activator is an effective treatment for acute ischemic stroke, but the number of treatable patients is limited. The PRomoting ACute Thrombolysis in Ischemic StrokE (PRACTISE) trial evaluated the effectiveness of a multidimensional implementation strategy for thrombolysis with intravenous recombinant tissue plasminogen activator in acute ischemic stroke. The PRACTISE trial was a national multicenter cluster-randomized controlled trial with randomization after pairwise matching. Twelve hospitals, both urban and community, academic and nonacademic, in the Netherlands participated. All patients admitted with stroke within 24 hours from onset of symptoms were registered. The intervention included 5 implementation meetings based on the Breakthrough Series model. The primary outcome was treatment with thrombolysis. Secondary outcomes were admission within 4 hours after onset of symptoms, death or disability at 3 months, and quality of life. Overall 5515 patients were included in the study' 308 patients (12.2%) in the control centers and 393 patients (13.1%) in the intervention centers were treated with thrombolysis (adjusted OR, 1.25; 95% CI, 0.93 to 1.68). Among the 1657 patients with ischemic stroke admitted within 4 hours from onset, 391 (44.5%) of 880 in the intervention centers were treated with thrombolysis and 305 (39.3%) of 777 in the control centers; the adjusted OR for treatment with thrombolysis was 1.58 (95% CI, 1.11 to 2.27). An intensive implementation strategy increases the proportion of patients with acute stroke treated with thrombolysis in real-life settings. An apparently pivotal factor in the improvement of the treatment rate is better application of contraindications for thrombolysis.

Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial

We investigated success factors for the introduction of a guideline on recognition of Lynch syndrome in patients recently diagnosed with colorectal cancer (CRC) below age 50 or a second CRC below age 70. Pathologists were asked to start microsatellite instability (MSI) testing and report to surgeons with the advice to consider genetic counselling when MSI test or family history was positive. A multicentre cluster-randomised controlled trial (ClinicalTrials.gov, number NCT00141466) was performed in 12 pathology laboratories (clusters), serving 29 community hospitals. All received an introduction to the new guideline. In the intervention group, surgeons received education and tumour test result reminders; pathologists were provided with inclusion criteria cards, an electronic patient inclusion reminder system and feedback on inclusion. Two hundred sixty-six CRC patients were eligible for recognition as at risk for Lynch syndrome. The actual recognition was 18% more successful in the intervention as compared to the control arm (77% (120 of 156) compared to 59% (65 of 110)), with an adjusted odds ratio (OR) = 2.8 (95% confidence interval (CI) 1.1–7.0). The electronic reminder system for pathologists was most strongly associated with recognition of high-risk patients, OR = 4.2 (95% CI 1.7–10.1). An electronic reminder system for pathologists appeared effective for adherence to a new complex guideline and will enhance the recognition of Lynch syndrome.

Prevention of bedside errors in transfusion medicine (PROBE‐TM) study: a cluster‐randomized, matched‐paired clinical areas trial of a simple intervention to reduce errors in the pretransfusion bedside check

Transfusion of the incorrect blood component is a frequent serious incident associated with transfusion and often involves misidentification of the patient and/or the unit of blood. The objective of this study was to assess the effect of a simple intervention designed to improve performance of the bedside check and to observe the durability of any effect. The intervention was a tag on blood bags reminding staff to check the patient's wristband. The tag was positioned in such a way that the transfusionist was required to remove the tag to spike the unit. The intervention was tested in a multicenter cluster-randomized controlled trial incorporating short-term and long-term follow-up periods. The primary endpoint was the proportion of patients transfused with red cell units for whom the key elements of the bedside check were all correctly completed. Fifteen matched-paired clinical areas at 12 participating hospitals in six countries were included in the trial. Combining data from all participating hospitals, the bedside check was correctly performed in 37 percent of transfusions during the baseline audit period. There was no evidence of a favorable effect of the intervention immediately after its introduction (pooled odds ratio, 1.09; 95% confidence interval, 0.54-2.17). There was similarly no evidence of a favorable effect after continued use of the intervention for an additional 8 weeks. A simple intervention in the form of a barrier warning label on blood bags reminding staff to check the patient's wristband failed to improve bedside transfusion practice. The robust study design developed for this study could be applied to investigate other interventions to improve the safety of bedside transfusion practice.