Browsing by Author "Chari, Radha"
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Item Open Access Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial(2020-03-19) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, AbhayAfter publication of our article [1], the authors have reported mathematical errors made in the sample size calculation for this cluster randomized controlled trial (cRCT) (Benzies et al. 2017).Item Open Access Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial(2020-11-28) Benzies, Karen M; Aziz, Khalid; Shah, Vibhuti; Faris, Peter; Isaranuwatchai, Wanrudee; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly J; Naugler, Christopher; Stelfox, H. T; Chari, Radha; Soraisham, Amuchou S; Akierman, Albert R; Phillipos, Ernest; Amin, Harish; Hoch, Jeffrey S; Zanoni, Pilar; Kurilova, Jana; Lodha, AbhayAbstract Background Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants’ care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. Methods In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. Results We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, − 4.44 to − 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. Conclusions Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. Trial registration ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.Item Open Access Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial(2017-10-10) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, AbhayAbstract 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.Item Open Access Shared decision making in pregnancy in inflammatory bowel disease: design of a patient orientated decision aid(2021-07-30) Williams, Astrid-Jane; Karimi, Neda; Chari, Radha; Connor, Susan; De Vera, Mary A.; Dieleman, Levinus A.; Hansen, Tawnya; Ismond, Kathleen; Khurana, Rshmi; Kingston, Dawn; O’Connor, Katie; Sadowski, Daniel C.; Fang-Hwa, Flora; Wine, Eytan; Leung, Yvette; Huang, VivianAbstract Background Research has indicated a lack of disease-specific reproductive knowledge among patients with Inflammatory Bowel Disease (IBD) and this has been associated with increased “voluntary childlessness”. Furthermore, a lack of knowledge may contribute to inappropriate medication changes during or after pregnancy. Decision aids have been shown to support decision making in pregnancy as well as in multiple other chronic diseases. A published decision aid for pregnancy in IBD has not been identified, despite the benefit of pre-conception counselling and patient desire for a decision support tool. This study aimed to develop and test the feasibility of a decision aid encompassing reproductive decisions in the setting of IBD. Methods The International Patient Decision Aid Standards were implemented in the development of the Pregnancy in IBD Decision Aid (PIDA). A multi-disciplinary steering committee was formed. Patient and clinician focus groups were conducted to explore themes of importance in the reproductive decision-making processes in IBD. A PIDA prototype was designed; patient interviews were conducted to obtain further insight into patient perspectives and to test the prototype for feasibility. Results Issues considered of importance to patients and clinicians encountering decisions regarding pregnancy in the setting of IBD included fertility, conception timing, inheritance, medications, infant health, impact of surgery, contraception, nutrition and breastfeeding. Emphasis was placed on the provision of preconception counselling early in the disease course. Decisions relating to conception and medications were chosen as the current focus of PIDA, however content inclusion was broad to support use across preconception, pregnancy and post-partum phases. Favourable and constructive user feedback was received. Conclusions The novel development of a decision aid for use in pregnancy and IBD was supported by initial user testing.Item Open Access Systematic review of the measurement properties of indices of prenatal care utilization(2020-03-18) Rowe, Stewart; Karkhaneh, Zahra; MacDonald, Isaiah; Chambers, Thane; Amjad, Sana; Osornio-Vargas, Alvaro; Chari, Radha; Kumar, Manoj; Ospina, Maria BAbstract Background An accurate assessment of the adequacy of prenatal care utilization is critical to inform the relationship between prenatal care and pregnancy outcomes. This systematic review critically appraises the evidence on measurement properties of prenatal care utilization indices and provides recommendations about which index is the most useful for this purpose. Methods MEDLINE, EMBASE, CINAHL, and Web of Science were systematically searched from database inception to October 2018 using keywords related to indices of prenatal care utilization. No language restrictions were imposed. Studies were included if they evaluated the reliability, validity, or responsiveness of at least one index of adequacy of prenatal care utilization. We used the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. We conducted an evidence synthesis using predefined criteria to appraise the measurement properties of the indices. Results From 2664 studies initially screened, 13 unique studies evaluated the measurement properties of at least one index of prenatal care utilization. Most of the indices of adequacy of prenatal care currently used in research and clinical practice have been evaluated for at least some form of reliability and/or validity. Evidence about the responsiveness to change of these indices is absent from these evaluations. The Adequacy Perinatal Care Utilization Index (APNCUI) and the Kessner Index are supported by moderate evidence regarding their reliability, predictive and concurrent validity. Conclusion The scientific literature has not comprehensively reported the measurement properties of commonly used indices of prenatal care utilization, and there is insufficient research to inform the choice of the best index. Lack of strong evidence about which index is the best to measure prenatal care utilization has important implications for tracking health care utilization and for formulating prenatal care recommendations.