Protocol for evaluating external facilitation as a strategy to nationally implement a novel stigma reduction training tool for healthcare providers.

BACKGROUND: Identity Development Evolution and Sharing (IDEAS) is a theatre-based intervention for reducing healthcare provider stigma. IDEAS films are created by collecting narratives from people who have experienced discrimination and healthcare inequity, partnering with professional playwrights to create theatrical scripts that maintain the words of the narratives while arranging them into compelling storylines involving several interviews, and hiring professional actors to perform and record scenes. IDEAS implementation requires a moderator to establish a respectful learning environment, play the filmed performance, set ground rules for discussion, and moderate a discussion between healthcare providers who viewed the film and invited panelists who are members of the minoritized population being discussed. IDEAS' impact on provider stigma is measured via pre/post Acceptance and Action Questionnaire - Stigma (AAQ-S) data collected from participating providers. The objectives of this manuscript are to provide narrative review of how provider stigma may lead to healthcare inequity and health disparities, describe the conceptual frameworks underpinning the IDEAS intervention, and outline methods for IDEAS implementation and implementation evaluation. METHODS: This manuscript describes a hybrid type 3 design study protocol that uses the Consolidated Framework for Implementation Research (CFIR) to evaluate external facilitation, used as an implementation strategy to expand the reach of IDEAS. CFIR is also used to assess the impact of characteristics of the intervention and implementation climate on implementation success. Implementation success is defined by intervention feasibility and acceptability as well as self-efficacy of internal facilitators. This manuscript details the protocol for collection and evaluation of implementation data alongside that of effectiveness data. The manuscript provides new information about the use of configurational analysis, which uses Boolean algebra to analyze pathways to implementation success considering each variable, within and across diverse clinical sites across the USA. DISCUSSION: The significance of this protocol is that it outlines important information for future hybrid type 3 designs wishing to incorporate configurational analyses and/or studies using behavioral or atypical, complex, innovative interventions. The current lack of evidence supporting occupational justice-focused interventions and the strong evidence of stigma influencing health inequities underscore the necessity for the IDEAS intervention.

Development, Validation, and Assessment of an Ischemic Stroke or Transient Ischemic Attack-Specific Prediction Tool for Obstructive Sleep Apnea.

BACKGROUND: Screening instruments for obstructive sleep apnea (OSA), as used routinely to guide clinicians regarding patient referral for polysomnography (PSG), rely heavily on symptomatology. We sought to develop and validate a cerebrovascular disease-specific OSA prediction model less reliant on symptomatology, and to compare its performance with commonly used screening instruments within a population with ischemic stroke or transient ischemic attack (TIA). METHODS: Using data on demographic factors, anthropometric measurements, medical history, stroke severity, sleep questionnaires, and PSG from 2 independently derived, multisite, randomized trials that enrolled patients with stroke or TIA, we developed and validated a model to predict the presence of OSA (i.e., Apnea-Hypopnea Index ≥5 events per hour). Model performance was compared with that of the Berlin Questionnaire, Epworth Sleepiness Scale (ESS), the Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, and Gender instrument, and the Sleep Apnea Clinical Score. RESULTS: The new SLEEP Inventory (Sex, Left heart failure, ESS, Enlarged neck, weight [in Pounds], Insulin resistance/diabetes, and National Institutes of Health Stroke Scale) performed modestly better than other instruments in identifying patients with OSA, showing reasonable discrimination in the development (c-statistic .732) and validation (c-statistic .731) study populations, and having the highest negative predictive value of all in struments. CONCLUSIONS: Clinicians should be aware of these limitations in OSA screening instruments when making decisions about referral for PSG. The high negative predictive value of the SLEEP INventory may be useful in determining and prioritizing patients with stroke or TIA least in need of overnight PSG.

Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial.

BACKGROUND: The "Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease" (GoToSleep) study is evaluating a strategy to improve the diagnosis and treatment of sleep apnea among veterans with stroke or transient ischemic attack (TIA) who also have hypertension. Specifically, the GoToSleep study was designed to overcome some of the barriers that exist within the Veterans Health Administration (VHA) to the timely diagnosis and treatment of sleep apnea by using ambulatory home-based polysomnography and auto-titrating continuous positive airway pressure (CPAP) to reduce the reliance on laboratory-based sleep studies. METHODS: The GoToSleep study is a prospective, multi-site, randomized, controlled strategy trial among an expected 318 veterans with cerebrovascular disease and hypertension who are assigned to an intervention group or a control group. Patients in the intervention group receive unattended polysomnography at baseline, and those with sleep apnea receive auto-titrating CPAP therapy for up to one year. Patients in the control group receive usual care and unattended polysomnography at the end of the study to identify the rate of undiagnosed sleep apnea. The primary objectives of the GoToSleep study are to determine whether a diagnostic and therapeutic intervention strategy among veterans with cerebrovascular disease and hypertension improves: (1) detection of sleep apnea; (2) appropriate treatment for sleep apnea; and (3) control of hypertension. Twenty-four-hour blood pressure assessments are made at baseline and at the end of the one-year study period for both groups. Antihypertensive medications and their doses are recorded at the time of the 24-hour blood pressure measurements. DISCUSSION: This manuscript provides the rationale for 4 key components of the design of the GoToSleep trial: the inclusion of patients with cerebrovascular disease and hypertension without the use of a measure of daytime sleepiness as an eligibility criterion; the use of portable polysomnography and auto-titrating CPAP in patients' homes rather than using sleep laboratory polysomnography with fixed pressure CPAP; the analytic approach to evaluating change in blood pressure in the context of change in antihypertensive medications; and the use of a usual care control group.