Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering >100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients e 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for ICU families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This R01 application proposes a randomized, controlled, multi-center clinical trial of such an intervention.
Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients;and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality. The research will be conducted in medical ICUs at 5 hospitals (4 academic centers/1 community hospital) over 5 years including 4 years of subject enrollment. Dyads of chronically critically ill patients and their families will be randomized within sites to receive either the intervention (Supportive Information Team [SIT] family meetings led by palliative care physician) plus the printed aid or usual care plus the printed aid. Communication between SIT and ICU physicians will be optimized through a structured and templated process. The ICU physician will also have the option to join intervention family meetings and, for all patients, decision-making will remain the responsibility of this physician with the family. Primary outcomes (collected by family interviews) are Family Anxiety/Depression, Family Post-Traumatic Stress Disorder, and Discussion of Preferences for Patient Goals of Care. We will also evaluate outcomes related to utilization of critical care resources including ICU and hospital lengths of stay.
A large and growing population of patients survive acute critical illness only to remain critically ill on a chronic basis, with continued dependence on mechanical ventilation and other intensive care therapies. Mostly older adults, these patients face poor health outcomes in the context of marked emotional impact and other burdens on their families as well as extraordinary health care costs. This multicenter, randomized, controlled clinical trial will test a generalizable and sustainable model to provide informational support and other assistance to families facing treatment decisions for the chronically critically ill, thereby improving patient- and family-focused outcomes as well as utilization of critical care resources, without increasing patient mortality.
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