scholarly journals Effectiveness of Alberta Family-Integrated Care on Neonatal Outcomes: A Cluster Randomized Controlled Trial

2021 ◽  
Vol 10 (24) ◽  
pp. 5871
Author(s):  
Madeleine Murphy ◽  
Vibhuti Shah ◽  
Karen Benzies
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Standard Care ◽  
Controlled Trial ◽  
Neonatal Outcomes ◽  
Randomized Controlled ◽  
Level Ii ◽  
Family Integrated Care ◽  
Cluster Randomized ◽  
Family Integrated

Family-Integrated Care (FICare) empowers parents to play an active role as a caregiver for their infant in the neonatal intensive care unit (NICU). This model of care is associated with improved neonatal outcomes, such as improved weight gain and higher breastfeeding rates at discharge in infants admitted to level III NICUs; however, its effectiveness in level II NICUs remains unproven. The objective of this study was to evaluate the effectiveness of the model on neonatal outcomes in a cluster randomized controlled trial conducted in 10 level II NICUs randomized to Alberta FICare or standard care. Mothers and their preterm infants born between 32+0 and 34+6 weeks’ gestational age were included. The primary outcome was the proportion of infants who regained their birth weight (BW) after 14 days of life. The analysis included 353 infants/308 mothers at Alberta FICare sites and 365 infants/306 mothers at standard care sites. There was no difference in the proportion of infants who had regained their BW by 14 days between the groups. A lack of perceived improved weight gain trajectory for those in the FICare group is attributed to a shorter length of hospital stay and infants being discharged prior to regaining BW.

scholarly journals Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Karen M. Benzies ◽  
◽  
Vibhuti Shah ◽  
Khalid Aziz ◽  
Wanrudee Isaranuwatchai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Level Ii ◽  
Family Integrated Care ◽  
Cluster Randomized ◽  
Family Integrated

Abstract Background Every year, about 15 million of the world’s infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. Methods We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Discussion Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. Trial registration ClinicalTrials.gov, ID: NCT02879799. Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

scholarly journals A Behavioral Economics–Electronic Health Record Module to Promote Appropriate Diabetes Management in Older Adults: Protocol for a Pragmatic Cluster Randomized Controlled Trial

10.2196/28723 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e28723
Author(s):  
Hayley M Belli ◽  
Andrea B Troxel ◽  
Saul B Blecker ◽  
Judd Anderman ◽  
Christina Wong ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Behavioral Economics ◽  
Standard Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

Background The integration of behavioral economics (BE) principles and electronic health records (EHRs) using clinical decision support (CDS) tools is a novel approach to improving health outcomes. Meanwhile, the American Geriatrics Society has created the Choosing Wisely (CW) initiative to promote less aggressive glycemic targets and reduction in pharmacologic therapy in older adults with type 2 diabetes mellitus. To date, few studies have shown the effectiveness of combined BE and EHR approaches for managing chronic conditions, and none have addressed guideline-driven deprescribing specifically in type 2 diabetes. We previously conducted a pilot study aimed at promoting appropriate CW guideline adherence using BE nudges and EHRs embedded within CDS tools at 5 clinics within the New York University Langone Health (NYULH) system. The BE-EHR module intervention was tested for usability, adoption, and early effectiveness. Preliminary results suggested a modest improvement of 5.1% in CW compliance. Objective This paper presents the protocol for a study that will investigate the effectiveness of a BE-EHR module intervention that leverages BE nudges with EHR technology and CDS tools to reduce overtreatment of type 2 diabetes in adults aged 76 years and older, per the CW guideline. Methods A pragmatic, investigator-blind, cluster randomized controlled trial was designed to evaluate the BE-EHR module. A total of 66 NYULH clinics will be randomized 1:1 to receive for 18 months either (1) a 6-component BE-EHR module intervention + standard care within the NYULH EHR, or (2) standard care only. The intervention will be administered to clinicians during any patient encounter (eg, in person, telemedicine, medication refill, etc). The primary outcome will be patient-level CW compliance. Secondary outcomes will measure the frequency of intervention component firings within the NYULH EHR, and provider utilization and interaction with the BE-EHR module components. Results Study recruitment commenced on December 7, 2020, with the activation of all 6 BE-EHR components in the NYULH EHR. Conclusions This study will test the effectiveness of a previously developed, iteratively refined, user-tested, and pilot-tested BE-EHR module aimed at providing appropriate diabetes care to elderly adults, compared to usual care via a cluster randomized controlled trial. This innovative research will be the first pragmatic randomized controlled trial to use BE principles embedded within the EHR and delivered using CDS tools to specifically promote CW guideline adherence in type 2 diabetes. The study will also collect valuable information on clinician workflow and interaction with the BE-EHR module, guiding future research in optimizing the timely delivery of BE nudges within CDS tools. This work will address the effectiveness of BE-inspired interventions in diabetes and chronic disease management. Trial Registration ClinicalTrials.gov NCT04181307; https://clinicaltrials.gov/ct2/show/NCT04181307 International Registered Report Identifier (IRRID) DERR1-10.2196/28723

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