Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial.

BACKGROUND: The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments. METHODS: To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor-patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared. RESULTS: During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion. CONCLUSION: The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.

Very early mobilization in stroke patients treated with intravenous recombinant tissue plasminogen activator.

BACKGROUND: There are limited prospective data on the relative safety of very early mobilization of stroke patients after intravenous recombinant tissue plasminogen activator (IV rtPA) in stroke patients. We hypothesized that very early patient mobilization within 24 hours after IV rtPA administration for acute ischemic stroke would be safe and feasible. METHODS: The study was a prospective observational safety and feasibility study involving very early mobilization of stroke patients by physical therapy/occupational therapy within 24 hours after IV rtPA administration for treatment of ischemic stroke. A premobilization safety checklist was completed before mobilization to ensure hemodynamic stability. We assessed adverse safety events, including changes in patient symptoms, changes in vital signs, and bleeding complications. RESULTS: Eighteen patients were enrolled in the study, and informed consent was obtained. One hundred percent of patients were evaluated with a premobilization safety checklist; 72.2% (13 of 18) were mobilized without any adverse event. Eighty-nine percent (42 of 47) of mobilization activities were tolerated without an adverse response. One patient was orthostatic, and 1 patient had transient worsening of hemiparesis. No patient had intracranial bleeding or permanent worsening of neurologic deficits. CONCLUSIONS: Very early mobilization within 24 hours of ischemic stroke for patients who receive IV rtPA appears to be relatively safe and feasible in most patients. Patients who are mobilized within 24 hours of IV rtPA require detailed neurologic and vital sign monitoring.

Subarachnoid Hemorrhage "Fast Track": A Health Economics and Health Care Redesign Approach for Early Selected Hospital Discharge.

OBJECTIVE: To determine whether earlier hospital discharge is feasible and safe in selected patients with subarachnoid hemorrhage (SAH) using an outpatient "fast-track" protocol. PATIENTS AND METHODS: We conducted a prospective quality improvement cohort study with the primary feasibility end point of patients with SAH deemed safe for discharge by treating team consensus. All patients received detailed education and outpatient transcranial Doppler monitoring; caregivers could contact the on-call team 24-7. Primary safety end points were adverse events after discharge and hospital readmission. RESULTS: From January 1, 2010, to January 1, 2015, our center had 377 SAH diagnoses, of which 200 were included in the final cohort, 36 qualifying for fast-track early discharge. The 30-day readmission rate for fast-track patients was 11.0% (4 of 36) compared with 11.4% (18 of 164) for non-fast-track patients. The rate of delayed cerebral ischemia and stroke was 3% (1 of 36) in the fast-track group vs 25.0% (41 of 164) for the non-fast-track group. Adverse events occurred in 11.0% (4 of 36) of the fast-track group compared with 26.0% (43 of 164) in the non-fast-track group. The mean length of stay was reduced 60% from 15 days to 6.6 days in the fast-track group. CONCLUSION: Although our fast-track group was relatively small, data suggested early feasibility and safety in a carefully selected group of patients with SAH. Direct and indirect financial benefits of early discharge over a 5-year period were an estimated savings at least $864,000 in overall costs. A comparative effectiveness study is planned to replicate and validate these results using a larger multicenter design.