ICU Family Communication Study

Three decades of research on end-of-life care in the United States indicate that people who
are dying often spend their final days receiving care they would not choose. The intensive
care unit (ICU) is an important focus for efforts to improve end-of-life care both because
death is common in this setting - approximately 20% of Americans die in or shortly after a
stay in the ICU - and also because care is highly technologic and, thus, expensive. As a
result of our prior work we have developed a wealth of knowledge about how to improve
communication and decision-making concerning end-of-life care in the ICU. One of the
important insights from this knowledge was the need for and development of a
facilitator-assisted interdisciplinary communication intervention. This intervention,
designed to improve communication and decision-making about end-of-life care in the ICU,
offers significant potential benefits for improving patient- and family-centered care for
five reasons: 1) communication is an integral component of clinician skill that affects all
other aspects of end-of-life care; 2) physicians and nurses in practice do not demonstrate
adequate skills for communicating about end-of-life care, especially in the ICU or acute
care setting; 3) interventions that have focused on improving communication within the ICU
team and between the team and the family have been shown to reduce the "prolongation of
dying" common in the ICU, but it remains unclear how to generalize these successes to other
hospitals; 4) a recent randomized trial in France used an intervention based on our prior
research and showed dramatic reductions in symptoms of anxiety, depression, and
post-traumatic stress disorder (PTSD) among family members after the patient's death, but it
is unclear how to translate these findings to hospitals in the U.S.; and 5) sustainable,
generalizable, and widely available interventions that improve communication about
end-of-life care are not available.

The long-term objectives are: 1) to demonstrate the efficacy of a generalizable
facilitator-assisted interdisciplinary communication intervention in the ICU to improve
family and patient outcomes; and 2) to demonstrate the feasibility of making this
intervention a routine part of clinical practice in the ICU setting.

The study will advance Nursing science by addressing an important area of emphasis within
Nursing science and a key component of the National Institute of Nursing Research's
strategic plan. One fifth of deaths in America occur in intensive care units and nurses
provide a key component of the care in this setting. With the aging population and
coincident advances in medical technology, more patients are likely to die after an
unsuccessful trial of intensive care. Prior research suggests that interventions to improve
communication about end-of-life care in the ICU may reduce the prolongation of dying that is
common in the ICU setting while at the same time improving the quality of care for patients
and family members. Unfortunately, this prior research does not provide a clear
generalizable intervention that can be easily implemented in academic and community
hospitals. The proposed randomized trial will test a feasible and generalizable
intervention to improve communication about end-of-life care and improve patient and family
outcomes.

The consent forms used for this study address the purpose, procedures, risks, alternatives,
benefits, and other information -- including emphasis on the voluntary nature of this
research and assurances of confidentiality.

The conceptual model for the intervention addresses three components of self-efficacy
theory: 1) knowledge, based on this team's prior research identifying components of
communication during ICU family conferences that are associated with improved patient and
family outcomes; 2) attitudes, informed by attachment theory as applied to clinician-patient
relationships and communication; and 3) communication behaviors informed by principles of
mediation based on identifying and resolving conflict in the healthcare setting.

The intervention includes the following steps: 1) in-person interviews by the facilitator
with the family prior to the family conference in order to discuss the family's concerns,
questions, needs and unique communication characteristics that will be addressed in the
family conference; 2) a pre-conference meeting with the facilitator, physician(s), nurse(s),
and other clinicians in which a brief summary describing the family's concerns, questions,
needs, and unique communication characteristics is presented and discussed; 3) facilitator
participation in the family conference; and 4) facilitator follow up with the family
throughout the ICU stay. Prior to the facilitator's involvement, both the intervention and
control group will meet with the research coordinator who will obtain consent from the
family and distribute baseline questionnaires; the research coordinator will also contact
both the intervention and control group families at the time of the follow-up questionnaires
(3 and 6 months after discharge or death) to notify them that questionnaires are being sent
to them and ask if they have any questions. The contacts through the research coordinator
are expected to enhance response rates for both groups. For the control group, these
contacts with the research coordinator will provide an "attention control." The research
coordinator will not provide any of the other intervention components provided by the
facilitator (i.e., discussion of concerns or questions prior to the family conference; brief
summary to clinicians; participation in the family conference; follow-up contact after the
family conference for duration of the ICU stay). A component of the facilitator's role will
also include helping to identify the need for a family conference and scheduling these
conferences. Therefore, as part of the multi-faceted intervention, we anticipate that
family conferences will occur earlier and more frequently in the intervention arm. After
the initial family conference, there may be additional family conferences and the
facilitator will participate in these conferences for the intervention group.

Inclusion Criteria:

- Patients, family members, clinicians attending ICU family conferences, and nurses
evaluating the quality of care.

- All ICU patients are eligible if they meet the age criteria, have been in the ICU for
at least 12 hours, have acute respiratory failure requiring mechanical ventilation at
the time of enrollment, and have an APACHE II score/SOFA score or other diagnosis
that predicts a 50% or greater risk of mortality.

- Eligible family members and/or friends may include any of the following: legal
guardians, durable power of attorney for healthcare, spouses, adult children,
parents, siblings, domestic partners, other relatives, and friends; if they meet the
age criteria, and understand English well enough to complete informed consent and
study materials.

- Eligible clinicians include those who are present during a family conference and may
include physicians, nurses, nurse practitioners, physician assistants, social
workers, respiratory therapists, and clergy.

- All critical care nurses are eligible to participate in the evaluation if they have
provided care to a patient on or before the shift in which he or she died or was
discharged from the ICU.

Exclusion Criteria:

- Legal or risk management concerns (as determined by the attending physician or via
hospital record designation);

- Psychological illness or morbidity; and

- Physical or mental limitations preventing ability to complete questionnaires.

- Patients will be excluded if they do not have at least one family member who is
eligible and willing to participate in the study.

- A patient who is readmitted to the ICU, if the patient was enrolled and discharged
previously, will not be eligible.

- Post-operative patients who have been admitted to the ICU after a scheduled surgery
without complications will be excluded. These patients may meet other eligibility
criteria (ventilation, APACHE scores, etc.) within the first 12 to 48 hours of
admission, but will usually improve quite rapidly after that period.