Training Intervention and Program of Support for Fostering the Adoption of Family-Centered Telehealth in Pediatric Rehabilitation: Protocol for a Multimethod, Prospective, Hybrid Type 3 Implementation-Effectiveness Study.

BACKGROUND: Children with disability face long wait times for rehabilitation services. Before the COVID-19 pandemic, telehealth adoption was low across pediatric rehabilitation. Owing to the COVID-19 pandemic restrictions, pediatric therapists were asked to rapidly shift to telehealth, often with minimal training. To facilitate the behavior changes necessary for telehealth adoption, provision of appropriate evidence-based training and support is required. However, evidence to support the effective implementation of such training is lacking. The successful real-world implementation of a training intervention and program of support (TIPS) targeting pediatric therapists to enhance the adoption of family-centered telerehabilitation (FCT) requires the evaluation of both implementation and effectiveness. OBJECTIVE: This study aimed to evaluate TIPS implementation in different pediatric rehabilitation settings and assess TIPS effectiveness, as it relates to therapists' adoption, service wait times, families' perception of service quality, and costs. METHODS: This 4-year, pan-Canadian study involves managers, pediatric occupational therapists, physiotherapists, speech-language pathologists, and families from 20 sites in 8 provincial jurisdictions. It will use a multimethod, prospective, hybrid type 3 implementation-effectiveness design. An interrupted time series will assess TIPS implementation. TIPS will comprise a 1-month training intervention with self-paced learning modules and a webinar, followed by an 11-month support program, including monthly site meetings and access to a virtual community of practice. Longitudinal mixed modeling will be used to analyze indicators of therapists' adoption of and fidelity to FCT collected at 10 time points. To identify barriers and facilitators to adoption and fidelity, qualitative data will be collected during implementation and analyzed using a deductive-inductive thematic approach. To evaluate effectiveness, a quasi-experimental pretest-posttest design will use questionnaires to evaluate TIPS effectiveness at service, therapist, and family levels. Generalized linear mixed effects models will be used in data analysis. Manager, therapist, and family interviews will be conducted after implementation and analyzed using reflective thematic analysis. Finally, cost data will be gathered to calculate public system and societal costs. RESULTS: Ethics approval has been obtained from 2 jurisdictions (February 2022 and July 2022); approval is pending in the others. In total, 20 sites have been recruited, and data collection is anticipated to start in September 2022 and is projected to be completed by September 2024. Data analysis will occur concurrently with data collection, with results disseminated throughout the study period. CONCLUSIONS: This study will generate knowledge about the effectiveness of TIPS targeting pediatric therapists to enhance FCT adoption in pediatric rehabilitation settings, identify facilitators for and barriers to adoption, and document the impact of telehealth adoption on therapists, services, and families. The study knowledge gained will refine the training intervention, enhance intervention uptake, and support the integration of telehealth as a consistent pediatric rehabilitation service option for families of children with disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05312827; https://clinicaltrials.gov/ct2/show/NCT05312827. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40218.

Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit.

BACKGROUND: Studies that have evaluated the use of intravenous vitamin C in adults with sepsis who were receiving vasopressor therapy in the intensive care unit (ICU) have shown mixed results with respect to the risk of death and organ dysfunction. METHODS: In this randomized, placebo-controlled trial, we assigned adults who had been in the ICU for no longer than 24 hours, who had proven or suspected infection as the main diagnosis, and who were receiving a vasopressor to receive an infusion of either vitamin C (at a dose of 50 mg per kilogram of body weight) or matched placebo administered every 6 hours for up to 96 hours. The primary outcome was a composite of death or persistent organ dysfunction (defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy) on day 28. RESULTS: A total of 872 patients underwent randomization (435 to the vitamin C group and 437 to the control group). The primary outcome occurred in 191 of 429 patients (44.5%) in the vitamin C group and in 167 of 434 patients (38.5%) in the control group (risk ratio, 1.21; 95% confidence interval [CI], 1.04 to 1.40; P = 0.01). At 28 days, death had occurred in 152 of 429 patients (35.4%) in the vitamin C group and in 137 of 434 patients (31.6%) in the placebo group (risk ratio, 1.17; 95% CI, 0.98 to 1.40) and persistent organ dysfunction in 39 of 429 patients (9.1%) and 30 of 434 patients (6.9%), respectively (risk ratio, 1.30; 95% CI, 0.83 to 2.05). Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes. In the vitamin C group, one patient had a severe hypoglycemic episode and another had a serious anaphylaxis event. CONCLUSIONS: In adults with sepsis receiving vasopressor therapy in the ICU, those who received intravenous vitamin C had a higher risk of death or persistent organ dysfunction at 28 days than those who received placebo. (Funded by the Lotte and John Hecht Memorial Foundation; LOVIT ClinicalTrials.gov number, NCT03680274.).

Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan.

BACKGROUND: The LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor. OBJECTIVE: We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database. METHODS: The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses. RESULTS: The SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status. CONCLUSIONS: We have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36261.