Protocol and Fidelity Monitoring Plan for Four Supports. A Multicenter Trial of an Intervention to Support Surrogate Decision Makers in Intensive Care Units.
Ann Am Thorac Soc
clinical trial; intensive care; intervention research; patient-centered; surrogate decision-making
Individuals acting as surrogate decision makers for critically ill patients frequently struggle in this role and experience high levels of long-term psychological distress. Prior interventions designed to improve the sharing of information by the clinical team with surrogate decision makers have demonstrated little effect on surrogates' outcomes or clinical decisions. In this report, we describe the study protocol and corresponding intervention fidelity monitoring plan for a multicenter randomized clinical trial testing the impact of a multifaceted surrogate support intervention (Four Supports) on surrogates' psychological distress, the quality of decisions about goals of care, and healthcare use. We will randomize the surrogates of 300 incapacitated critically ill patients at high risk of death and/or severe long-term functional impairment to receive the Four Supports intervention or an education control. The Four Supports intervention adds to the intensive care unit (ICU) team a trained interventionist (family support specialist) who delivers four types of protocolized support-emotional support; communication support; decisional support; and, if indicated, anticipatory grief support-to surrogates through daily interactions during the ICU stay. The primary outcome is surrogates' symptoms of anxiety and depression at 6-month follow-up, measured with the Hospital Anxiety and Depression Scale. Prespecified secondary outcome measures are the Patient Perception of Patient Centeredness Scale (modified for use with surrogates) and Impact of Event Scale scores at 3- and 6-month follow-up, respectively, together with ICU and hospital lengths of stay and total hospital cost among decedents. The fidelity monitoring plan entails establishing and measuring adherence to the intervention using multiple measurement methods, including daily checklists and coding of audiorecorded encounters. This approach to intervention fidelity may benefit others designing and testing behavioral interventions in the ICU setting. Clinical trial registered with www.clinicaltrials.gov (NCT01982877).
Seaman, Jennifer B; Arnold, Robert M; Buddadhumaruk, Praewpannarai; Shields, Anne-Marie; Gustafson, Rachel M; Felman, Kristyn; Newdick, Wendy; SanPedro, Rachel; Mackenzie, Suzanne; Morse, Jennifer Q; Chang, Chung-Chou H; Happ, Mary Beth; Song, Mi-Kyung; Kahn, Jeremy M; Reynolds, Charles F; Angus, Derek C; Landefeld, Seth; and White, Douglas B, "Protocol and Fidelity Monitoring Plan for Four Supports. A Multicenter Trial of an Intervention to Support Surrogate Decision Makers in Intensive Care Units." (2018). Articles, Abstracts, and Reports. 624.