Search results

The standard care of hospital or emergency department patients experiencing an acute ischemic stroke includes intravenously administered tissue plasminogen activator (tPA). Mobile stroke units (MSUs) are ambulances equipped with staff and a computed tomographic scanner that can allow for tPA to be administered more quickly. This comparative effectiveness trial examined clinical outcomes in stroke patients who received either an earlier diagnosis and treatment using an MSU or standard triage and transport by Emergency Medical Services (EMS). The sample included multicenter cohorts with randomized deployment weeks and blinded assessment of both trial entry and clinical outcomes.

In an effort to make hearing aids more affordable and accessible to U.S. adults with hearing difficulty, the Food and Drug Administration (FDA) empowered these adults to self-fit over-the-counter (OTC) hearing aids. The effectiveness of two self-fit methods, Consumer Decides (CD) and Efficient Fitting (EF), was hypothesized to be non-inferior to the professional-fit method, (Audiology Based, AB). This was evaluated for both short-term (6 weeks post-fit) and long-term (6 months post-fit) outcomes.

The BRITE study (Brain Injury Rehabilitation: Improving the Transition Experience) was a six-center, 1:1 randomized controlled pragmatic trial with masked outcome assessment that compared the effectiveness of two established approaches to managing transition from inpatient rehabilitation facility discharge to the next phase of care for individuals with moderate-to-severe traumatic brain injury (TBI). The two established transition methods were (1) a standardized version of existing discharge procedures used at all six sites and (2) a standardized remotely-delivered case management approach that extended beyond the point of discharge, based on the protocol used within the Veteran's Health Administration and enhanced with input from patient and family stakeholders. The sample was stratified by site and discharge location (skilled nursing facility vs. discharge to home/community) based on the relatively lower frequency of discharge to facility (22 percent across all six study sites in 2015) and the expectation of high impact of discharge destination on outcomes. When a caregiver was available for an enrolled patient, they were also approached for consent to be surveyed, with some patients having up to two caregivers enrolled to account for changes in primary caregiver.

The following key outcome domains were assessed: (1) ability of patients to participate in the home and community as independently as possible, (2) health-related quality of life, (3) access to appropriate healthcare and reduced emergent or urgent healthcare, and (4) caregiver outcomes. These outcomes were assessed at 3, 6, 9 and 12 months after discharge from inpatient care. Participants were also given the standard TBI Model Systems follow-up assessment one-year post-injury. Types of medical insurance coverage and satisfaction with healthcare were examined at 6 and 12 months post-discharge.