Evaluating an informed consent process designed to improve inclusion of adults with intellectual disability in research.

BACKGROUND: Adults with intellectual disability (ID) are both underrepresented in research and enrolled in studies they may not understand. Instead of facilitating research engagement, the informed consent process often fails to elucidate its essential elements. AIMS: We evaluated whether a novel informed consent process was more effective than current practice at helping adults with ID understand key elements of research. METHODS AND PROCEDURES: 21 adults with ID completed a novel iterative teaching process (ITP) for teaching and assessing informed consent. The ITP was used to compare the baseline (Conventional) approach to an Easy Read and a Conversational approach. Participants were asked a series of questions to assess their attitudes toward, and their comprehension of, the materials. OUTCOMES AND RESULTS: The pilot found encouraging evidence for the efficacy and feasibility of the ITP. The two novel ITP approaches were both superior to current practice. CONCLUSIONS AND IMPLICATIONS: This project contributes to a growing literature by introducing a process for teaching and evaluating informed consent. Results indicate that comprehension of informed consent materials can be taught to, and learned by, adults with ID with proper accommodations.

Getting comfortable with disability: The short- and long-term effects of a clinical encounter.

BACKGROUND: Physicians report discomfort when interacting with patients with disabilities, which can negatively impact the quality of healthcare they provide. OBJECTIVE/HYPOTHESIS: An intervention structured around a formative clinical encounter was assessed for its effectiveness in changing comfort towards treating patients with disabilities. It was predicted that this encounter would have a positive short- and long-term impact on medical students. METHOD: During the 2017-2018 academic year, 169 third-year medical students conducted a patient encounter with a person who had a disability. Students met individually with the "patient" and completed a brief social and medical history as if they were meeting a new patient to establish care. A measure of perceived comfort caring for patients with disabilities was administered to students before and after the encounter. One year after the patient encounter, 59 students were surveyed about their satisfaction and the impact of the patient encounter. RESULTS: The impact of encountering people with disabilities in a clinical setting was positive, with statistically significant improvements across all items on the measure of perceived comfort. Students were highly satisfied with the experience and anticipated feeling more confident, more comfortable, less awkward, and more skilled and efficacious when encountering a person with a disability in their future practice. A thematic analysis of the one year follow-up data suggest that students valued the encounter and desired more content on disability throughout their education. CONCLUSIONS: Medical education should include dedicated exposure to persons with disabilities and a simulated patient experience allowing for a safe environment to gain skills and confidence.

Lithium Treatment for Agitation in Alzheimer's disease (Lit-AD): Clinical rationale and study design.

Symptoms of agitation, aggression, and psychosis frequently occur in patients with Alzheimer's disease (AD). These symptoms are distressing to patients and caregivers, often lead to institutionalization, are associated with increased mortality, and are very difficult to treat. Lithium is an established treatment for bipolar and other psychotic disorders in which agitation can occur. The Lit-AD study is the first randomized, double-blind, placebo-controlled trial to assess the efficacy of lithium treatment for symptoms of agitation or aggression, with or without psychosis, in older adults diagnosed with AD. Patients are randomly assigned to low dose (150-600 mg) lithium or placebo, targeting a blood level of 0.2-0.6 mmol/L, stratified by the presence/absence of psychotic symptoms. The study duration for each patient is 12 weeks. The primary study outcome is change in the agitation/aggression domain score on the Neuropsychiatric Inventory (NPI) over the study period. The secondary outcome is improvement in neuropsychiatric symptoms defined as a 30% decrease in a NPI core score that combines agitation/aggression and psychosis domain scores. The Treatment Emergent Symptom Scale (TESS) is used to assess somatic side effects. Other exploratory analyses examine the associations between improvement on lithium and indices shown to be associated with response to lithium in bipolar disorder: serum brain-derived neurotrophic factor (BDNF) levels, a SNP in intron 1 of the ACCN1 gene, and variation at the 7q11.2 gene locus. If lithium demonstrates efficacy in this Phase II pilot trial, a Phase III study will be developed to establish its clinical utility in these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02129348.