Cluster-randomized Effectiveness Trial Research Articles

Impact of Home Fortification of Complementary Foods Program on Child Anemia and Stunting in Bihar, India

Home fortification of complementary foods with multiple micronutrient powders (MMP) is recommended to reduce child anemia in resource‐poor settings. However, there is a lack of program effectiveness data in Bihar, India to guide policies. We conducted a cluster randomized effectiveness trial in West Champaran, Bihar in over 4000 children aged 6–18 months for a duration of one year, within the context of an ongoing program (CARE, India: Integrated Family Health Initiative) delivered by community front line workers. 70 health sub‐centers were randomized to intervention (MMPs and Infant and Young Child Feeding (IYCF) counseling) or control (only IYCF counseling). The MMPs included a daily RDA of iron, zinc, iodine, folic acid, and vitamins A, C and B12, for children. The study aimed to determine impact on measures of nutritional status (anemia, stunting, underweight and wasting) and child feeding practices and inform potential statewide scale‐up. A secondary objective was to examine potentially adverse outcomes (diarrhea, hospitalization and fever). We used a difference in difference approach using cross‐sectional baseline and endline surveys to evaluate impact and adjusted for caste, socioeconomic status, age, gender, maternal education, young mother status, and religion. The duration of the intervention was one year and at baseline, 72% of children were anemic and 33% were stunted. Although 86% of caretakers indicated that they would like to continue using the powders, only 38% of children had consumed MMPs in the last month and 24% were currently consuming MMP at endline. Anemia declined significantly by 7.8% (6.7% in adjusted models; p<0.05) with a greater decline among children 12–18 months (9.3%, p<0.05). There were no overall effects on the prevalence of stunting, underweight or wasting but there was a significant decline of 8.4% in stunting for children aged 12–18 months (7.2% in adjusted models; p<0.05). There were no significant differences in IYCF (age of initiation of complementary feeding, feeding frequency, dietary diversity or minimum acceptable diet). There were no differences in severe morbidity (bloody diarrhea, severe diarrhea, persistent diarrhea, hospitalizations or fever) and there was a significant 4% decrease in the prevalence of any diarrhea self‐reported in past 2 weeks in the intervention communities. In conclusion, home fortification of complementary foods is a promising intervention associated with modest improvements in anemia and possibly stunting within the existing government run program context in Bihar, India.Support or Funding InformationFunding support provided by a BMGF grant through a subcontract with CARE‐India

Prenatal Lipid-Based Nutrient Supplements Affect Maternal Anthropometric Indicators Only in Certain Subgroups of Rural Bangladeshi Women

Background: Maternal undernutrition and low macro- and micronutrient intake and weight gain during pregnancy have been reported in Bangladesh.Objective: We aimed to determine the effects of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on weight gain and midupper arm circumference (MUAC) during pregnancy.Methods: The Rang-Din Nutrition Study, a cluster-randomized effectiveness trial conducted in Bangladesh, enrolled 4011 pregnant women at ≤20 wk gestation who received either 60 mg Fe + 400 μg folic acid/d or 20 g LNS-PL/d (118 kcal) containing essential fatty acids and vitamins and minerals until delivery. At 36 wk gestation, women were interviewed at home and then attended a follow-up examination at local clinics (n = 2877), where anthropometric measurements were taken.Results: No significant differences between intervention groups in maternal weight gain per week, low weight gain per week, or MUAC at 36 wk gestation were observed in the full sample. However, among multiparous women aged ≥25 y, those in the LNS-PL group gained 34 g/wk more than their counterparts in the iron and folic acid (IFA) group (P = 0.001), whereas no differences were seen in the other parity/age subgroups. Women aged ≥25 y in the LNS-PL group had a 0.4-cm greater MUAC than their counterparts in the IFA group (P = 0.003); no significant differences were observed in the other age groups. Among women whose height at baseline was in the lowest quartile of the distribution, those in the LNS-PL group had a 0.1–0.3-cm greater MUAC at 36 wk gestation than those in the IFA group (P = 0.004–0.014).Conclusions: Lipid-based nutrient supplements provided during pregnancy did not affect maternal anthropometric indicators in the overall sample but increased MUAC among women aged ≥25 y and those with lower stature and weight gain among multiparous women aged ≥25 y. This trial was registered at clinicaltrials.gov as NCT01715038.

Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial.

A previous study in Pakistan assessed the effectiveness of delivering responsive stimulation and enhanced nutrition interventions to young children. Responsive stimulation significantly improved children's cognitive, language, and motor development at 2 years of age. Both interventions significantly improved parenting skills, with responsive stimulation showing larger effects. In this follow-up study, we investigated whether interventions had benefits on children's healthy development and care at 4 years of age. We implemented a follow-up study of the initial, community-based cluster-randomised effectiveness trial, which was conducted through the Lady Health Worker programme in Sindh, Pakistan. We re-enrolled 1302 mother-child dyads (87% of the 1489 dyads in the original enrolment) for assessment when the child was 4 years of age. The children were originally randomised in the following groups: nutrition education and multiple micronutrient powders (enhanced nutrition; n=311), responsive stimulation (n=345), combined responsive stimulation and enhanced nutrition (n=315), and routine health and nutrition services (control; n=331). The data collection team were masked to the allocated intervention. The original enrolment period included children born in the study area between April 1, 2009, and March 31, 2010, if they were up to 2·5 months old without signs of severe impairments. The primary endpoints for children were development and growth at 4 years of age. Interventions were given in monthly group sessions and in home visits. The primary endpoint for mothers was wellbeing and caregiving knowledge, practices, and skills when the child was 4 years of age. Analysis was by intention to treat. The original trial is registered with ClinicalTrials.gov, number NCT00715936. 1302 mother-child dyads were re-enrolled between Jan 1, 2013, and March 31, 2013, all of whom were followed up at 4 years of age. Children who received responsive stimulation (with or without enhanced nutrition) had significantly higher cognition, language, and motor skills at 4 years of age than children who did not receive responsive stimulation. For children who received responsive stimulation plus enhanced nutrition, effect sizes (Cohen's d) were 0·1 for IQ (mean difference from control 1·2, 95% CI -0·3 to 2·7), 0·3 for executive functioning (0·18, -0·07 to 0·29), 0·5 for pre-academic skills (7·53, 5·14 to 9·92) and 0·2 for pro-social behaviours (0·08, 0·03 to 0·13). For children who received responsive stimulation alone, effect sizes were 0·1 for IQ (mean difference with controls 1·7, -0·3 to 3·7), 0·3 for executive functioning (0·17, 0·07 to 0·27), 0·2 for pre-academic skills (3·86, 1·41 to 6·31), and 0·2 for pro-social behaviours (0·07, 0·02 to 0·12). Enhanced nutrition improved child motor development, with effect size of 0·2 for responsive stimulation plus enhanced nutrition (0·56, -0·03 to 1·15), and for enhanced nutrition alone (0·82, 0·18 to 1·46). Mothers who received responsive stimulation (with or without enhanced nutrition) had significantly better responsive caregiving behaviours at 4 years of child age than those who did not receive intervention. Effect size was 0·3 for responsive stimulation plus enhanced nutrition (1·95, 0·75 to 3·15) and 0·2 for responsive stimulation (2·01, 0·74 to 3·28). The caregiving environment had a medium effect size of 0·3 for all interventions (responsive stimulation plus enhanced nutrition 2·99, 1·50 to 4·48; responsive stimulation alone 2·82, 1·21 to 4·43; enhanced nutrition 3·52, 1·70 to 5·34). Responsive stimulation delivered in a community health service can improve child development and care, 2 years after the end of intervention. Future analyses of these data are needed to identify which children and families benefit more or less over time. Grand Challenges Canada.

Evaluation of the effects of iodized salt on the mental development of preschool-aged children: a cluster randomized trial in northern Ethiopia.

A cluster randomized effectiveness trial was used to examine the effects on mental development of introducing iodized salt to children 4 to 6 years of age in Ethiopia, where there were reportedly high levels of iodine deficiency. Sixty district clusters were randomized to receive iodized salt early at their markets with assistance from regular salt distributors or later as introduced by market forces. At pre- and post-iodization, 1602 children were given cognitive/language tests (namely School Readiness, WPPSI verbal reasoning, WPPSI Matrix reasoning), and mothers were interviewed concerning demographics, nutrition and health. Children's weight, height, urine and a blood sample were taken. Analyses of covariance, adjusting for clustering and baseline levels were conducted. Urinary iodine concentrations were significantly higher at endline in the intervention children than controls though both medians were above threshold. Overall, less than 5% were anemic. There were no significant main effect differences between groups on the cognitive/language tests, but there were effect modifiers, namely mother's education, child's sex and diet. For example, the intervention group performed better on the school readiness test than controls if their mothers had attended school, but not otherwise. In conclusion, the data are consistent with negative findings from studies where children 6 to 12 years were supplemented with an iodine capsule, indicating that the benefits of iodine, in salt or capsule form, for brain development may be restricted to children under 3 years. Yet, benefits may be tied to those with more educational resources or may compensate for conditions of disadvantage.

Determinants of Developmental Milestones in Infants and Young Children in Bihar, India

Approximately 200 million children globally fail to fulfill their developmental potential. Children in Bihar, India may be at particularly high risk as the extensive malnutrition in the region could have important implications for brain development. The objectives of this study are to use baseline data from an ongoing cluster randomized effectiveness trial of home fortification with micronutrient powders in Bihar to 1) validate a modified version of the Developmental Milestones Checklist II (DMC‐II) and 2) determine nutritional and socioeconomic risk factors for mental and motor development of infants and young children.Cross‐sectional data from 4360 children 6–18 months of age living in West Champaran district of Bihar, India, were used to determine the predictive validity of the modified DMC‐II by comparing scores by age, nutritional status, and maternal education. Multivariate regression was used to examine determinants of child development score.The mean score on the modified DMC‐II was 40.9 (95%CI 40.6, 41.3) out of 82.0. The overall score and scores for each subscale (motor, language, personal‐social, and cognitive) were significantly associated with child age and maternal education. After adjustment for age, overall and all subscale scores were each significantly associated with height‐for‐age, weight‐for‐age, and weight‐for‐height z‐scores. A multivariate linear model for the child's overall modified DMC‐II scores (R2=0.60) revealed significant associations (P<0.05) with age (coefficient (SE): 2.49 (0.05)), gender (−0.84 (0.28)), height‐for‐age z‐score (0.57 (0.15)) weight‐for‐age z‐score (1.10 (0.17)), dietary diversity score (1.00 (0.14)), timely initiation of complementary foods (1.00 (0.29)), no use of prelacteal feeds (0.67 (0.29)), Family Care Indicators or home stimulation (0.56 (0.04)), and maternal education (0.97 (0.30)). Recent morbidity (fever, cough, or diarrhea) was not significantly associated with DMC‐II scores in the multivariate model.Predictive validity of the DMC‐II was established in this population. Comparison of standardised regression coefficients identified weight‐for‐age z‐score, Family Care Indicators, and dietary diversity as the strongest determinants of the child's overall score on the developmental milestones; length‐for‐age z‐score, weight‐for‐age z‐score, and weight‐for‐length z‐score were the strongest predictors of score on the motor development subscale. Strategies to improve child development should simultaneously address these issues.Support or Funding InformationFunding support provided by a BMGF grant through a subcontract with CARE‐India

Lipid-based nutrient supplements for pregnant women reduce newborn stunting in a cluster-randomized controlled effectiveness trial in Bangladesh

Maternal undernutrition and newborn stunting [birth length-for-age z score (LAZ) <-2] are common in Bangladesh. The objective was to evaluate the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PLs) on birth outcomes. We conducted a cluster-randomized effectiveness trial (the Rang-Din Nutrition Study) within a community health program in rural Bangladesh. We enrolled 4011 pregnant women at ≤20 gestational weeks; 48 clusters received iron and folic acid (IFA; 60 mg Fe + 400 μg folic acid) and 16 clusters received LNS-PLs (20 g/d, 118 kcal) containing essential fatty acids and 22 vitamins and minerals. Both of the supplements were intended for daily consumption until delivery. Primary outcomes were birth weight and length. Infants in the LNS-PL group had higher birth weights (2629 ± 408 compared with 2588 ± 413 g; P = 0.007), weight-for-age z scores (-1.48 ± 1.01 compared with -1.59 ± 1.02; P = 0.006), head-circumference-for-age z scores (HCZs; -1.26 ± 1.08 compared with -1.34 ± 1.12; P = 0.028), and body mass index z scores (-1.57 ± 1.05 compared with -1.66 ± 1.03; P = 0.005) than those in the IFA group; in adjusted models, the differences in length (47.6 ± 0.07 compared with 47.4 ± 0.04 cm; P = 0.043) and LAZ (-1.15 ± 0.04 compared with -1.24 ± 0.02; P = 0.035) were also significant. LNS-PLs reduced the risk of newborn stunting (18.7% compared with 22.6%; RR: 0.83; 95% CI: 0.71, 0.97) and small head size (HCZ <-2) (20.7% compared with 24.9%; RR: 0.85; 95% CI: 0.73, 0.98). The effects of LNS-PL on newborn stunting were greatest in infants born before a 10-wk interruption in LNS-PL distribution (n = 1301; 15.7% compared with 23.6%; adjusted RR: 0.69; 95% CI: 0.53, 0.89) and in infants born to women ≤24 y of age or with household food insecurity. Prenatal lipid-based nutrient supplements can improve birth outcomes in Bangladeshi women, especially those at higher risk of fetal growth restriction. This trial was registered at clinicaltrials.gov as NCT01715038.

Reducing suicidal ideation in home health care: results from the CAREPATH depression care management trial.

The study evaluated the effectiveness of a depression care management intervention in reducing suicidal ideation (SI) among home health patients. Data come from the cluster-randomized effectiveness trial of the Depression Care for Patients at Home (Depression CAREPATH), an intervention that integrates depression care management into the routine nursing visits of Medicare home health patients screening positive for depression. Patients were interviewed at baseline, 3, 6, and 12-month follow-up. SI was measured using the Hamilton Rating Scale for Depression item. We compared likelihood of any level of SI between intervention and usual care patients using longitudinal logistic mixed-effects models. A total of 306 eligible patients enrolled in the trial. Among them, 70 patients (22.9%) reported SI at baseline. Among patients with SI, patients under the care of nurses randomized to CAREPATH were less likely to report SI over the study period (odds ratio = 0.51, 95% CI; 0.24-1.07), with 63.6% of usual care versus 31.3% of CAREPATH participants continuing to report SI after one year. Baseline major depression, greater perceived burdensomeness, and greater functional disability were associated with greater likelihood of SI. SI is reported in more than 10% of Medicare home health patients. The Depression CAREPATH intervention was associated with a reduction in patients reporting SI at one year, compared to enhanced usual care. Given relative low burden on nursing staff, depression care management may be an important component of routine home health practices producing long-term reduction in SI among high-risk patients. Copyright © 2015 John Wiley & Sons, Ltd.

Clinical Effectiveness of Integrating Depression Care Management Into Medicare Home Health

ImportanceAmong older home health care patients, depression is highly prevalent, is often inadequately treated, and contributes to hospitalization and other poor outcomes. Feasible and effective interventions are needed to reduce this burden of depression.ObjectiveTo determine whether, among older Medicare Home Health recipients who screen positive for depression, patients of nurses receiving randomization to an intervention have greater improvement in depressive symptoms during 1 year than patients receiving enhanced usual care.Design, Setting, and ParticipantsThis cluster randomized effectiveness trial conducted at 6 home health care agencies nationwide assigned nurse teams to an intervention (12 teams) or to enhanced usual care (9 teams). Between January 13, 2009, and December 6, 2012, Medicare Home Health patients 65 years and older who screened positive for depression on routine nursing assessments were recruited, underwent assessment, and were followed up at 3, 6, and 12 months by research staff blinded to intervention status. Patients were interviewed at home and by telephone. Of 502 eligible patients, 306 enrolled in the study.InterventionsThe Depression Care for Patients at Home (Depression CAREPATH) trial requires nurses to manage depression at routine home visits by weekly symptom assessment, medication management, care coordination, education, and goal setting. Nurses’ training totaled 7 hours (4 onsite and 3 via the web). Researchers telephoned intervention team supervisors every other week.Main Outcomes and MeasuresDepression severity, assessed by the 24-item Hamilton Scale for Depression (HAM-D).ResultsThe 306 participants were predominantly female (69.6%), were racially/ethnically diverse (18.0% black and 16.0% Hispanic), and had a mean (SD) age of 76.5 (8.0) years. In the full sample, the intervention had no effect (P = .13 for intervention × time interaction). Adjusted HAM-D scores (Depression CAREPATH vs control) did not differ at 3 months (10.5 vs 11.4, P = .26) or at 6 months (9.3 vs 10.5, P = .12) but reached significance at 12 months (8.7 vs 10.6, P = .05). In the subsample with mild depression (HAM-D score, <10), the intervention had no effect (P = .90), and HAM-D scores did not differ at any follow-up points. Among 208 participants with a HAM-D score of 10 or higher, the Depression CAREPATH demonstrated effectiveness (P = .02), with lower HAM-D scores at 3 months (14.1 vs 16.1, P = .04), at 6 months (12.0 vs 14.7, P = .02), and at 12 months (11.8 vs 15.7, P = .005).Conclusion and RelevanceHome health care nurses can effectively integrate depression care management into routine practice. However, the clinical benefit seems to be limited to patients with moderate to severe depression.Trial Registrationclinicaltrials.gov Identifier: NCT01979302

Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial

Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential. We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker (LHW) programme in Sindh, Pakistan. We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh, Pakistan, with a 2 × 2 factorial design. We randomly allocated 80 clusters (LHW catchments) of children to receive routine health and nutrition services (controls; n=368), nutrition education and multiple micronutrient powders (enhanced nutrition; n=364), responsive stimulation (responsive stimulation; n=383), or a combination of both enriched interventions (n=374). The allocation ratio was 1:20 (ie, 20 clusters per intervention group). The data collection team were masked to the allocated intervention. All children born in the study area between April, 2009, and March, 2010, were eligible for enrolment if they were up to 2·5 months old without signs of severe impairments. Interventions were delivered by LHWs to families with children up to 24 months of age in routine monthly group sessions and home visits. The primary endpoints were child development at 12 and 24 months of age (assessed with the Bayley Scales of Infant and Toddler Development, Third Edition) and growth at 24 months of age. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT007159636. 1489 mother-infant dyads were enrolled into the study, of whom 1411 (93%) were followed up until the children were 24 months old. Children who received responsive stimulation had significantly higher development scores on the cognitive, language, and motor scales at 12 and 24 months of age, and on the social-emotional scale at 12 months of age, than did those who did not receive the intervention. Children who received enhanced nutrition had significantly higher development scores on the cognitive, language, and social-emotional scales at 12 months of age than those who did not receive this intervention, but at 24 months of age only the language scores remained significantly higher. We did not record any additive benefits when responsive stimulation was combined with nutrition interventions. Responsive stimulation effect sizes (Cohen's d) were 0·6 for cognition, 0·7 for language, and 0·5 for motor development at 24 months of age; these effect sizes were slightly smaller for the combined intervention group and were low to moderate for the enhanced nutrition intervention alone. Children exposed to enhanced nutrition had significantly better height-for-age Z scores at 6 months (p<0·0001) and 18 months (p=0·02) than did children not exposed to enhanced nutrition. Longitudinal analysis showed a small benefit to linear growth from enrolment to 24 months (p=0·026) in the children who received the enhanced nutrition intervention. The responsive stimulation intervention can be delivered effectively by LHWs and positively affects development outcomes. The absence of a major effect of the enhanced nutrition intervention on growth shows the need for further analysis of mediating variables (eg, household food security status) that will help to optimise future nutrition implementation design. UNICEF.

Disseminating alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial.

In 2005 the American College of Surgeons passed a mandate requiring that level I trauma centers have mechanisms to identify and intervene with problem drinkers. The aim of this investigation was to determine if a multi-level trauma center intervention targeting both providers and patients would lead to higher-quality alcohol screening and brief intervention (SBI) when compared with trauma center mandate compliance without implementation enhancements. Cluster randomized trial in which intervention site (site n = 10, patient n = 409) providers received 1-day workshop training on evidence-based motivational interviewing (MI) alcohol interventions and four 30-minute feedback and coaching sessions; control sites (site n = 10, patient n = 469) implemented the mandate without study team training enhancements. Trauma centers in the United States of America. A total of 878 blood alcohol-positive in-patients with and without traumatic brain injury (TBI). MI skills of providers were assessed with fidelity coded standardized patient interviews. All patients were interviewed at baseline and 6- and 12-months post-injury with the Alcohol Use Disorders Identification Test (AUDIT). Intervention site providers consistently demonstrated enhanced MI skills compared with control providers. Intervention patients demonstrated an 8% reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury (relative risk = 0.88, 95%, confidence interval = 0.79, 0.98). Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of traumatic brain injury (TBI) (P = 0.002). Trauma center providers can be trained to deliver higher-quality alcohol screening and brief intervention (SBI) than untrained providers, which is associated with modest reductions in alcohol use problems, particularly among patients without TBI.

Goodstart: a cluster randomised effectiveness trial of an integrated, community‐based package for maternal and newborn care, with prevention of mother‐to‐child transmission of HIV in a South African township

Progress towards MDG4 for child survival in South Africa requires effective prevention of mother-to-child transmission (PMTCT) of HIV including increasing exclusive breastfeeding, as well as a new focus on reducing neonatal deaths. This necessitates increased focus on the pregnancy and early post-natal periods, developing and scaling up appropriate models of community-based care, especially to reach the peri-urban poor. We used a randomised controlled trial with 30 clusters (15 in each arm) to evaluate an integrated, scalable package providing two pregnancy visits and five post-natal home visits delivered by community health workers in Umlazi, Durban, South Africa. Primary outcomes were exclusive and appropriate infant feeding at 12 weeks post-natally and HIV-free infant survival. At 12 weeks of infant age, the intervention was effective in almost doubling the rate of exclusive breastfeeding (risk ratio 1.92; 95% CI: 1.59-2.33) and increasing infant weight and length-for-age z-scores (weight difference 0.09; 95% CI: 0.00-0.18, length difference 0.11; 95% CI: 0.03-0.19). No difference was seen between study arms in HIV-free survival. Women in the intervention arm were also more likely to take their infant to the clinic within the first week of life (risk ratio 1.10; 95% CI: 1.04-1.18). The trial coincided with national scale up of ARVs for PMTCT, and this could have diluted the effect of the intervention on HIV-free survival. We have demonstrated that implementation of a pro-poor integrated PMTCT and maternal, neonatal and child health home visiting model is feasible and effective. This trial could inform national primary healthcare reengineering strategies in favour of home visits. The dose effect on exclusive breastfeeding is notable as improving exclusive breastfeeding has been resistant to change in other studies targeting urban poor families.

Cost effectiveness of responsive stimulation and nutrition interventions on early child development outcomes in Pakistan.

Early childhood programs are heralded as a way to improve children's health and educational outcomes. However, few studies in developing countries calculate the effectiveness of quality early childhood interventions. Even fewer estimate the associated costs of such interventions. The study here looks at the costs and effectiveness of a cluster-randomized effectiveness trial on children from birth to 24 months in rural Sindh, Pakistan. Responsive stimulation and/or enhanced nutrition interventions were integrated in the Lady Health Worker program in Pakistan. Outcomes suggest that children who receive responsive stimulation had significantly better development outcomes at 24 months than those who only received enhanced nutrition intervention. A cost-effectiveness analysis of the results verifies that early childhood interventions that include responsive stimulation are more cost effective than a nutrition intervention alone in promoting children's early development. Costs of a responsive stimulation intervention integrated in an existing community-based service providing basic health and nutrition care is approximately US$4 per month per child. We discuss these findings and make recommendations about scaling up and costs for future early child development programs.

A (Pan-Canadian) cluster randomized control effectiveness trial of the ABRACADABRA web-based literacy program.

This report describes a cluster randomized control trial (RCT) intervention study of the effectiveness of the ABRACADABRA (ABRA) Web-based literacy system using a classroom-level RCT intervention with 1,067 children in 74 kindergarten and Grade 1 or Grade 1/2 classrooms across Canada. The authors closely followed the CONSORT criteria for executing and reporting high-quality RCT studies. Well-trained teachers delivered the ABRA intervention to their regular classrooms for 20 hr per child over one full semester. At posttest, the ABRA intervention classroom showed significant advantages over controls in phonological blending ability, letter–sound knowledge and, marginally, for phoneme segmentation fluency. A secondary analysis exploring the effects of different levels of program implementation showed that with fidelity of implementation (80% of intervention teachers), advantages were evident at posttests in phonological blending, phoneme segmentation fluency, sight word reading, and letter–sound knowledge. It is concluded that ABRA is an effective resource for key skills associated with early reading. Implications for the role of both Web-based technologies and extended professional development for technology in aiding in the scale-up of evidence-based reading interventions are discussed.

Personal health records and hypertension control: a randomized trial

To examine the impact of a personal health record (PHR) in patients with hypertension measured by changes in biological outcomes, patient empowerment, patient perception of quality of care, and use of medical services. A cluster-randomized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics. 453 of 1686 (26.4%) patients approached were included in the analyses. A PHR tethered to the patient's electronic medical record (EMR) was the primary intervention and included security measures, patient control of access, limited transmission of EMR data, blood pressure (BP) tracking, and appointment assistance. BP was the main outcome measure. Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale. Quality of care was assessed using the Clinician and Group Assessment Score (CAHPS) and the Patient Assessment of Chronic Illness Care. Frequency of use of medical services was self-reported. No impact of the PHR was observed on BP, patient activation, patient perceived quality, or medical utilization in the intention-to-treat analysis. Sub-analysis of intervention patients self-identified as active PHR users (25.7% of those with available information) showed a 5.25-point reduction in diastolic BP. Younger age, self-reported computer skills, and more positive provider communication ratings were associated with frequency of PHR use. Few patients provided with a PHR actually used the PHR with any frequency. Thus simply providing a PHR may have limited impact on patient BP, empowerment, satisfaction with care, or use of health services without additional education or clinical intervention designed to increase PHR use. http://ClinicalTrials.gov Identifier: NCT01317537.

Medication intensification in diabetes in rural primary care: a cluster-randomised effectiveness trial

ObjectiveTo determine the effectiveness of a provider-based intervention to improve medication intensification among patients with diabetes.DesignEffectiveness cluster-randomised trial. Baseline and follow-up cross-sections of diabetes physicians’ patients.SettingEleven U.S. Southeastern states, 2006–2008.Participants205...

A web-based diabetes intervention for physician: a cluster-randomized effectiveness trial

To determine the effectiveness of a provider-based education and implementation intervention for improving diabetes control. Cluster-randomized trial with baseline and follow-up cross sections of diabetes patients in each participating physician's practice. Eleven US Southeastern states, 2006-08. Two hundred and five rural primary care physicians. Multi-component interactive intervention including Web-based continuing medical education, performance feedback and quality improvement tools. Primary Outcome Measures 'Acceptable control' [hemoglobin A1c ≤9%, blood pressure (BP) <140/90 mmHg, low-density lipoprotein cholesterol (LDL) <130 mg/dl] and 'optimal control' (A1c <7%, BP <130/80 mmHg, LDL <100 mg/dl). Of 364 physicians attempting to register, 205 were randomized to the intervention (n= 102) or control arms (n= 103). Baseline and follow-up data were provided by 95 physicians (2127 patients). The proportion of patients with A1c ≤9% was similar at baseline and follow-up in both the control [adjusted odds ratio (AOR): 0.94; 95% confidence interval (CI): 0.61, 1.47] and intervention arms [AOR: 1.16 (95% CI: 0.80, 1.69)]; BP <140/90 mmHg and LDL <130 mg/dl were also similar at both measurement points (P= 0.66, P= 0.46; respectively). We observed no significant effect on diabetes control attributable to the intervention for any of the primary outcome measures. Intervention physicians engaged with the Website over a median of 64.7 weeks [interquartile range (IQR): 45.4-81.8) for a median total of 37 min (IQR: 16-66). A wide-reach, low-intensity, Web-based interactive multi-component intervention did not improve control of glucose, BP or lipids for patients with diabetes of physicians practicing in the rural Southeastern US.

Improvement of perinatal and newborn care in rural Pakistan through community-based strategies: a cluster-randomised effectiveness trial

Newborn deaths account for 57% of deaths in children younger than 5 years in Pakistan. Although a large programme of trained lady health workers (LHWs) exists, the effectiveness of this training on newborn outcomes has not been studied. We aimed to evaluate the effectiveness of a community-based intervention package, principally delivered through LHWs working with traditional birth attendants and community health committees, for reduction of perinatal and neonatal mortality in a rural district of Pakistan. We undertook a cluster randomised trial between February, 2006, and March, 2008, in Hala and Matiari subdistricts, Pakistan. Catchment areas of primary care facilities and all affiliated LHWs were used to define clusters, which were allocated to intervention and control groups by restricted, stratified randomisation. The intervention package delivered by LHWs through group sessions consisted of promotion of antenatal care and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of careseeking; control clusters received routine care. Independent data collectors undertook quarterly household surveillance to capture data for births, deaths, and household practices related to maternal and newborn care. Data collectors were masked to cluster allocation; those analysing data were not. The primary outcome was perinatal and all-cause neonatal mortality. Analysis was by intention to treat. This trial is registered, ISRCTN16247511. 16 clusters were assigned to intervention (23,353 households, 12,391 total births) and control groups (23,768 households, 11,443 total births). LHWs in the intervention clusters were able to undertake 4428 (63%) of 7084 planned group sessions, but were only able to visit 2943 neonates (24%) of a total 12,028 livebirths in their catchment villages. Stillbirths were reduced in intervention clusters (39·1 stillbirths per 1000 total births) compared with control (48·7 per 1000; risk ratio [RR] 0·79, 95% CI 0·68-0·92; p=0·006). The neonatal mortality rate was 43·0 deaths per 1000 livebirths in intervention clusters compared with 49·1 per 1000 in control groups (RR 0·85, 0·76-0·96; p=0·02). Our results support the scale-up of preventive and promotive maternal and newborn interventions through community health workers and emphasise the need for attention to issues of programme management and coverage for such initiatives to achieve maximum potential. WHO; Saving Newborn Lives Program of Save the Children USA, funded by the Bill & Melinda Gates Foundation.

A Cluster-Randomized Effectiveness Trial of a Physician-Pharmacist Collaborative Model to Improve Blood Pressure Control

Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

A cluster-randomized effectiveness trial of smoking cessation modified for at-risk smoker subgroups

A. Batra, S.E. Collins, I. Torchalla, M. Schröter, and G. Buchkremer (2008) showed that smokers reporting higher levels of nicotine dependence, novelty seeking/hyperactivity, and depressivity (i.e., at-risk smokers) evinced higher rates of posttreatment smoking than smokers reporting lower scores on self-report psychological symptom measures (i.e., lower risk smokers). This study aimed to replicate the smoker subgroups and test the comparative effectiveness of standard pharmacobehavioral smoking cessation versus modified smoking cessation matched to at-risk smokers' needs. On the basis of their self-report responses, adult regular smokers ( N = 268) were classified into smoker subgroups. At-risk smokers were randomly assigned to receive the standard or modified treatments; lower risk smokers received standard treatment. Modified treatment produced higher abstinence rates than the standard treatment for depressive smokers but not for other at-risk smokers. Overall, abstinence rates among at-risk smokers receiving modified treatment were not significantly different from those of lower risk smokers; however, abstinence among higher dependence smokers receiving modified treatment decreased at higher rates than among lower risk smokers.

The impact of school fruit tuck shops and school food policies on children’s fruit consumption: a cluster randomised trial of schools in deprived areas

Aims:To estimate the impact of school fruit tuck shops on children’s consumption of fruit and sweet and savoury snacks.Design:Cluster randomised effectiveness trial with school as the unit of randomisation.Setting:43 primary...