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Clinical Research Services

Current projects

The CTU has supported the following clinical trials:

PI: Project Title: Funding:
Dr. Daniel Roth MDIG Trial Gates Foundation.
Dr. Peter Szatmari Among at-risk youth with mental health challenges do integrated collaborative care teams provide more benefits in reducing symptoms, improving functioning and provide greater client satisfaction than treatment as usual? Submitted to OSSU for funding
Dr. Christian Vaillancourt A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients with the Canadian C-Spine Rule and Selectively Transport them Without Immobilization OSSU IMPACT funding

 

1. Dr. Daniel Roth:  MDIG Trial

Fetal and early childhood growth has a profound effect on infectious disease susceptibility, mortality, and long-term functional and social outcomes. In Bangladesh, it has been estimated that nearly half of all children under five years of age are stunted (length/height substantially below the typical range). Vitamin D is a dominant endocrine regulator of bone mineral homeostasis, but the role of vitamin D supplementation in promoting prenatal and early infant bone growth remains unclear. The Maternal Vitamin D for Infant Growth (MDIG) trial is currently enrolling pregnant women in Dhaka, Bangladesh to test the hypothesis that maternal prenatal/postpartum vitamin D3 supplementation improves infant linear growth up to one year of age in a setting with a high prevalence of childhood stunting.

Women at 17-24 weeks of gestation are randomized to receive either one of three doses of vitamin D supplement or placebo throughout pregnancy; participants in the highest dose vitamin D arm are further randomized to either receive placebo or continuation of vitamin D supplementation for a six month postpartum period. All infants enrolled in the study will be followed until two years of age to assess the persistence of the observed effects measured at one year of age. The trial protocol includes a wide range of clinical data and specimen collection procedures to study the mechanisms by which vitamin D and its related endocrine factors influence linear growth in infancy.

2. Dr. Peter Szatmari:  Among at-risk youth with mental health challenges, do integrated collaborative care teams provide more benefits in reducing symptoms, improving functioning and provide greater client satisfaction than treatment as usual?

The prevalence of psychiatric disorders (including addictions) is roughly 20% in youth (13-25 years). 75% of all adult disorders begin in adolescence. Yet this vulnerable population is poorly served by existing mental health services that are often characterized by long wait lists, lack of integration, poor discharge planning and by being “unwelcoming” to youth. As a result, youth generally do not access services or follow through with treatment planning and may not receive appropriate care. This lack of appropriate care often results in long-term impairment and reduced quality of life.

This study will examine the benefits of an Integrated Collaborative Care Team (ICCT) approach to helping high-risk youth with mental health challenges. We have developed partnerships with several community agencies, three child and adolescent psychiatry hospital departments and a family health team (FHT) to implement an innovative outreach and walk-in clinic. The ICCT can provide rapid access to system navigation, peer support, web-based treatments, and evidence-based interventions provided by clinicians and matched to the level of youth need. This model will be compared to the usual treatment youth receive in community- or hospital-based mental health clinics in two Ontario communities.

3. Dr. Christian Vaillancourt:  A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients with the Canadian C-Spine Rule and Selectively Transport them Without Immobilization

Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly.

We developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without X-rays and missed injury. We have recently taught Ottawa paramedics to use the CCR in the field. This allows them to transport eligible patients to the hospital without immobilization devices. They have evaluated 3,854 patients, 60% were transported without immobilization, and all those with a c-spine injury were correctly identified and immobilized.

With the support of our Patient Safety Committee and Research Ethics Board, and the engagement of patients and paramedics, we will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested we include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. We will also measure the impact on the ED, and how much money could be saved if we allowed more paramedics to use the CCR. We will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.

Greater than 60% of all eligible trauma patients (300,000 in Ontario) can be transported safely and comfortably without c-spine immobilization devices.  Implementation of the CCR by Ontario paramedics would reduce patient discomfort, paramedic intervention times, ED crowding, unnecessary X-rays, and healthcare costs. This could be achieved rapidly and with lower healthcare cost compared to current practices (possible cost saving of $36 per immobilization, or $10,656,000 per year).  If successful, paramedics from across the province and country could soon be using the CCR.

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