scholarly journals Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Karel O’Brien ◽  
Marianne Bracht ◽  
Kate Robson ◽  
Xiang Y. Ye ◽  
Lucia Mirea ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Care Model ◽  
Randomized Controlled ◽  
The Family ◽  
Family Integrated Care ◽  
Cluster Randomized ◽  
Family Integrated

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 Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother’s own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jie Huo ◽  
Xinping Wu ◽  
Chuanli Gu ◽  
Zhangbin Yu ◽  
Jun Zhang ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Premature Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Lactation Consultant ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Mother’S Own Milk

Abstract Background The benefits of mother’s own milk (MOM) for preterm infants have been widely recognized. Many studies have shown that the rate of breastfeeding of premature infants remains very low. Although many studies use measures to promote breastfeeding, few high-quality cluster randomized controlled studies have evaluated the effectiveness of these measures. WeChat is an instant messaging software for smart terminals, and WeChat mini-programs have been widely used to promote health and self-management in China. Based on this background, we designed a randomized controlled study based on WeChat mini-programs to promote MOM feeding of premature infants in the neonatal intensive care unit (NICU). Methods/design This study will evaluate the effectiveness of WeChat mini-programs to increase the consumption of MOM feeding in twelve NICUs in Jiangsu Province, namely, six “intervention” NICUs and six “control” NICUs. The study process is as follows: (1) design and preparation, (2) NICU recruitment and training, (3) interpretation and analysis of baseline data, (4) quality control implementation process, and (5) data analysis feedback and publication of study reports. The primary outcome is the proportion of MOM feeding of premature infants during NICU hospitalization. The secondary outcomes are as follows: (1) time to initiation of MOM feeding (hours) and proportion of first-time MOM feeding (%), (2) duration of parenteral nutrition (days), (3) time to total gastrointestinal feeding (days), (4) hospitalization time and hospitalization cost, and (5) incidence of complications (necrotizing enterocolitis, bronchopulmonary dysplasia, feeding intolerance, late-onset sepsis, retinopathy of prematurity). Discussion This study is the first cluster randomized controlled trial on the intervention of using a WeChat mini-program-based lactation consultant for premature infants in the NICU in China. We hope this study can improve the consumption of MOM by NICU premature infants during hospitalization through the intervention of WeChat mini-programs. Trial registration ClinicalTrials.gov NCT04383379. Registered on May 5, 2020.

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 Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

Sign in / Sign up

Export Citation Format

Share Document