Each year in the United States, approximately 1 million patients receive life-sustaining mechanical ventilation (MV) in the intensive care unit (ICU) for respiratory failure. The financial burden of critical illness ranges from $121-$263B/year which is comparable to annual cancer care costs. To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to patients based on subjective observations of arousal and motor activity. While sedation is indicated at times, it can have serious side effects including delayed weaning, mental status changes, delirium, prolonged MV, and extended ICU stay. Symptom management strategies are needed that do not cause serious side effects, are safe and alleviate distressful MV-induced symptoms such as anxiety. Self-management of sedative therapy (SMST) by mechanically ventilated patients (MVPs) may be one such novel strategy. This RCT aims to: 1) Determine the efficacy of SMST compared to nurse-administered sedative therapy (NAST) on anxiety, duration of mechanical ventilation, and delirium in MVPs; 2) Examine level of arousal, alertness and sedative exposure in MVPs randomized to SMST compared to those MVPs receiving NAST; and, 3) Explore post-ICU outcomes between MVPs randomized to SMST compared to those receiving NAST. A sample of 190 adult MVPs will be recruited from the medical and surgical ICUs at The Ohio State University Medical Center in Columbus, OH. Patients will be randomly allocated to SMST with dexmedetomidine (Precedex(r)) or usual care of NAST. Assessments three times each day for up to 7 days include: anxiety (visual analog scale), arousal and alertness (Richmond Agitation-Sedation Scale (RASS)), delirium presence or absence (Confusion Assessment Method-ICU (CAM- ICU)), and all sedative medications. Post-ICU outcomes at 3- and 6-months will be assessed by telephone interview on: physical & functional status (Katz Activities of Daily Living, Functional Activities Questionnaire), psychological well-being (Patient Health Questionnaire, Post-traumatic Stress Disorder Checklists), and health- related quality of life (Short Form-36). Data analyses will include graphing, descriptive statistic, multi-level mixed models, and generalized estimating equations. The goal of this RCT is to demonstrate efficacy of SMST by MVPs to inform a future pragmatic effectiveness trial in day-to-day ICU practice. This new R01 is aligned with two NINR priorities: 1) promoting self-management across acute and chronic conditions, and 2) advancing the science of symptom management. While self-management is usually reserved for community-dwelling persons with chronic conditions, we will apply self-management science in a new population: critically ill MVPs. SMST advances symptom science by empowering MVPs to self-manage anxiety rather than relying on bedside ICU nurses to palliate this burdensome, highly individual symptom. This study contributes to the long- term goals of our research which are to empower MVPs to self-manage their symptoms in order to reduce ICU- acquired complications and promote post-ICU quality of life in this large patient population.
A majority of the 55,000 adults who receive care each day in intensive care units (ICUs) in the United States require mechanical ventilatory support to treat respiratory failure from a variety of causes. While the common practice of administering sedative medications to patients by ICU nurses is intended to treat anxiety and distress that arise from intubation and mechanical ventilation, this goal is not achieved. Demonstrating the value of self-management of sedative therapy by mechanically ventilated patients for has the potential to positively impact outcomes for this large ICU patient population.