Baby thinkingTrial Overview, Aims and Hypotheses

Overview. Our CDR implementation trial will demonstrate the CDR’s impact on AHT screening accuracy in PICU settings. We predict that CDR application as an AHT screening tool will increase AHT detection and reduce unnecessary abuse evaluations of patients with non-AHT. A clear demonstration of the CDR’s positive clinical impacts, and an evaluation of avenues to promote its sustainability, will inform and accelerate subsequent efforts to disseminate the CDR more broadly.

We will conduct a stratified cluster randomized trial (SCRT) at eight, university-based, U.S. PICUs randomly assigned to intervention (n = 4) or control (n = 4) conditions. The SCRT will compare AHT screening accuracy after the deployment of active, multifaceted, CDR implementation strategies designed to promote CDR acceptance and application at the intervention sites. These strategies include physician training, onsite visits, site-specific feedback, information sharing sessions, booster emails to providers, CDR badge cards, and access to a mobile-device “AHT Probability Calculator”.

The SCRT should last 36 months, but could be extended to 42 months. The trial protocol does not require doctors to ask any questions, order any tests, request any consultations, capture any additional patient-related data, or make any reports of suspected child abuse that, in their own clinical judgment, fall outside the scope of their standard patient care.

We will conduct the CDR implementation trial with the following specific aims:

Aim 1 : Conduct a SCRT across eight PICUs to assess the CDR’s impact on AHT screening accuracy. In comparison to non-intervention control sites, we hypothesize that deployment of our CDR implementation strategies at the intervention sites will be associated with higher percentages of high risk patients evaluated thoroughly for abuse (with skeletal survey and retinal exam), and lower percentages of low risk patients evaluated (even partially) for abuse (with skeletal survey and/or retinal exam).

Aim 2 : Identify site-, physician- and patient-specific factors that impact CDR application in PICU settings. We hypothesize that [1] PICU sites with higher volumes of eligible patients will demonstrate higher percentages of high risk patients evaluated thoroughly for abuse, and lower percentages of low risk patients evaluated (even partially) for abuse; [2] physicians with child abuse expertise, with higher measures of CDR acceptability, or with higher exposures to our CDR implementation strategies will demonstrate higher percentages of high risk patients evaluated thoroughly for abuse; and [3] minority patients, or patients less than six months, will be predictive of higher percentages of low risk patients evaluated (even partially) for abuse.

Exploratory Aim 3 : Once the SCRT has concluded, conduct a 12-month sustainability trial at intervention sites whereby implementation strategies are systematically omitted one-by-one in order to discern their relative importance to sustainability.

Our simple, safe, inexpensive, reliable, readily accessible, evidence-based, and validated CDR will become the very first child abuse screening tool to undergo a formal clinical trial. Applied accurately and consistently, the CDR could decrease the negative impacts of physicians’ inherent biases and practice disparities, increase AHT detection, decrease unnecessary abuse evaluations (and their associated risks), and reduce AHT-associated acute health care costs. Most importantly, the CDR will save lives—the lives of children who will suffer additional fatal inflicted injuries if/when their AHT is missed or unrecognized.