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Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity.

ABSTRACT: INTRODUCTION:Technological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. Complex care for kids Ontario (CCKO) brings researchers, families and healthcare providers together to develop, implement and evaluate a population-level roll-out of care for CMC in Ontario, Canada through a randomised controlled trial (RCT) design. The intervention includes dedicated key workers and the utilisation of coordinated shared care plans. METHODS AND ANALYSIS:Our primary objective is to evaluate the CCKO intervention using a randomised waitlist control design. The waitlist approach involves rolling out an intervention over time, whereby all participants are randomised into two groups (A and B) to receive the intervention at different time points determined at random. Baseline measurements are collected at month 0, and groups A and B are compared at months 6 and 12. The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months. The FECC will be compared between groups using an analysis of covariance with the corresponding baseline score as the covariate. Secondary outcomes include reports of child and parent health outcomes, health system utilisation and process outcomes. ETHICS AND DISSEMINATION:Research ethics approval has been obtained for this multicentre RCT. This trial will assess the effect of a large population-level complex care intervention to determine whether dedicated key workers and coordinated care plans have an impact on improving service delivery and quality of life for CMC and their families. TRIAL REGISTRATION NUMBER:NCT02928757.

SUBMITTER: Orkin J

PROVIDER: S-EPMC6688698 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity.

Orkin Julia J Chan Carol Y CY Fayed Nora N Lin Jia Lu Lilian JLL Major Nathalie N Lim Audrey A Peebles Erin R ER Moretti Myla E ME Soscia Joanna J Sultan Roxana R Willan Andrew R AR Offringa Martin M Guttmann Astrid A Bartlett Leah L Kanani Ronik R Culbert Erin E Hardy-Brown Karolyn K Gordon Michelle M Perlmutar Marty M Cohen Eyal E

BMJ open 20190801 8

<h4>Introduction</h4>Technological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. ...[more]

PMID: 31375613

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Project description:IntroductionGirl child, early and forced marriage (CEFM) persists in South Asia, with long-term consequences for girls. CARE's Tipping Point Initiative (TPI) addresses the causes of CEFM by challenging repressive gender norms and inequalities. The TPI engages different participant groups on programmatic topics and supports community dialogue to build girls' agency, shift inequitable power relations, and change community norms sustaining CEFM.Methods/analysisThe Nepal TPI impact evaluation has an integrated, mixed-methods design. The quantitative evaluation is a three-arm, cluster randomised controlled trial (control; Tipping Point Programme (TPP); TPP+ with emphasised social norms change). Fifty-four clusters of ~200 households were selected from two districts (27:27) with probability proportional to size and randomised. A household census ascertained eligible study participants, including unmarried girls and boys 12-16 years (1242:1242) and women and men 25+ years (270:270). Baseline participation was 1134 girls, 1154 boys, 270 women and 270 men. Questionnaires covered agency; social networks/norms; and discrimination/violence. Thirty in-depth interviews, 8 key-informant interviews and 32 focus group discussions were held across eight TPP/TPP+ clusters. Guides covered gender roles/aspirations; marriage decisions; girls' safety/mobility; collective action; perceived shifts in child marriage; and norms about girls. Monitoring involves qualitative interviews, focus groups and session/event observations over two visits. Qualitative analyses follow a modified grounded theory approach. Quantitative analyses apply intention to treat, regression-based difference-in-difference strategies to assess impacts on primary (married, marriage hazard) and secondary outcomes, targeted endline tracing and regression-based methods to address potential selection bias.Ethics/disseminationThe Nepal Social Welfare Council approved CARE Nepal to operate in the study districts. Emory (IRB00109419) and the Nepal Health Research Council (161-2019) approved the study. We follow UNICEF and CARE guidelines for ethical research involving children and gender-based violence. Study materials are here or available on request. We will share findings through clinicaltrials.gov, CARE reports/briefs and publications.Trial registration numberNCT04015856.

Project description:From 2008 to 2014, the Healthy Kids, Healthy Communities (HKHC) national program funded 49 communities across the United States and Puerto Rico to implement healthy eating and active living policy, system, and environmental changes to support healthier communities for children and families, with special emphasis on reaching children at highest risk for obesity on the basis of race, ethnicity, income, or geographic location. Evaluators designed a mixed-methods evaluation to capture the complexity of the HKHC projects, understand implementation, and document perceived and actual impacts of these efforts. Eight complementary evaluation methods addressed 4 primary aims seeking to (1) coordinate data collection for the evaluation through the web-based project management system (HKHC Community Dashboard) and provide training and technical assistance for use of this system; (2) guide data collection and analysis through use of the Assessment and Evaluation Toolkit; (3) conduct a quantitative cross-site impact evaluation among a subset of community partnership sites; and (4) conduct a qualitative cross-site process and impact evaluation among all 49 community partnership sites. Evaluators identified successes and challenges in relation to the following methods: an online performance-monitoring HKHC Community Dashboard system, environmental audits, direct observations, individual and group interviews, partnership and community capacity surveys, group model building, photographs and videos, and secondary data sources (surveillance data and record review). Several themes emerged, including the value of systems approaches, the need for capacity building for evaluation, the value of focusing on upstream and downstream outcomes, and the importance of practical approaches for dissemination. The mixed-methods evaluation of HKHC advances evaluation science related to community-based efforts for addressing childhood obesity in complex community settings. The findings are likely to provide practice-relevant evidence for public health.

Project description:BackgroundImmersive virtual reality (VR) is a promising therapy to improve the experience of patients with critical illness and may help avoid postdischarge functional impairments. However, the determinants of interest and usability may vary locally and reports of uptake in the literature are variable.ObjectiveThe aim of this mixed methods feasibility study was to assess the acceptability and potential utility of immersive VR in critically ill patients at a single institution.MethodsAdults without delirium who were admitted to 1 of 2 intensive care units were offered the opportunity to participate in 5-15 minutes of immersive VR delivered by a VR headset. Patient vital signs, heart rate variability, mood, and pain were assessed before and after the VR experience. Pre-post comparisons were performed using paired 2-sided t tests. A semistructured interview was administered after the VR experience. Patient descriptions of the experience, issues, and potential uses were summarized with thematic analysis.ResultsOf the 35 patients offered the chance to participate, 20 (57%) agreed to partake in the immersive VR experience, with no difference in participation rate by age. Improvements were observed in overall mood (mean difference 1.8 points, 95% CI 0.6-3.0; P=.002), anxiety (difference of 1.7 points, 95% CI 0.8-2.7; P=.001), and pain (difference of 1.3 points, 95% CI 0.5-2.1; P=.003) assessed on 1-10 scales. The heart rate changed by a mean of -1.1 (95% CI -0.3 to -1.9; P=.008) beats per minute (bpm) from a baseline of 86.1 (SD 11.8) bpm and heart rate variability, assessed by the stress index (SI), changed by a mean of -5.0 (95% CI -1.5 to -8.5; P=.004) seconds-2 from a baseline SI of 40.0 (SD 23) seconds-2. Patients commented on the potential for the therapy to address pain, lessen anxiety, and facilitate calmness. Technical challenges were minimal and there were no adverse effects observed.ConclusionsPatient acceptance of immersive VR was high in a mostly medical intensive care population with little prior VR experience. Patients commented on the potential of immersive VR to ameliorate cognitive and emotional symptoms. Investigators can consider integrating minimally modified commercial VR headsets into the existing intensive care unit workflow to further assess VR's efficacy for a variety of endpoints.

Dataset Information

Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity.

Publications

Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity.

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