ABSTRACT
The National Academy of Medicine and the National Institutes of Health have called for urgent
action to improve the care delivered to the nearly 1,000,000 elderly Americans who die in
intensive care units (ICUs) annually, or survive with severe disabilities. The problems include: 1)
patients with a poor prognosis often receive more invasive, burdensome treatment than they
would choose for themselves; 2) family members acting as surrogate decision-makers find the
experience emotionally overwhelming and suffer lasting psychological distress; and 3) treatment
in ICUs contributes to high end-of-life health care costs. These problems are especially
important to elderly patients, whose willingness to undergo invasive, life-prolonging treatments
varies and hinges on highly personal values and preferences. Despite widespread recognition of
these problems, there are no readily-scalable interventions that are proven effective to assist
surrogates in ICUs. Over the last 3 years (R21AG050252), we used a multi-stakeholder process
to first develop, then iteratively refine the Family Support Tool, an interactive, web-based tool to
help family members of elderly, incapacitated patients navigate the emotional, psychological,
and cognitive complexities of being a surrogate decision-maker. We then established in a
single-center RCT that the intervention is feasible, acceptable, improves the quality of clinician-
family communication, and is perceived to be highly beneficial by surrogates in ICUs. We
propose to conduct an appropriately powered randomized clinical trial of the Family Support
Tool among the surrogates of 450 elderly, critically ill patients at high risk of death or severe
disability. In Aims 1 and 2, we will determine the effect of the Family Support Tool on patients’
clinical outcomes, surrogates’ psychological outcomes, measures of decision quality, and end-
of-life healthcare utilization. In Aim 3, we will conduct a qualitative study in parallel with the RCT
to identify the contextual factors, barriers, and facilitators that may influence the efficacy of the
Family Support Tool. The research is highly significant because it will establish the efficacy of a
low-cost, scalable intervention to overcome major public health problems that affect hundreds of
thousands of Americans annually. This proposal is innovative because the intervention
challenges the existing paradigm of how to support surrogates facing difficult decisions near the
end of life. The work is feasible in our hands because our team of established investigators
successfully developed and pilot tested the Family Support Tool, has a proven record of
success conducting trials in ICUs, and has buy-in for participation from all sites.
