Helping Older Persons Emerge Stronger

The 300,000 chronically critically ill patients each year who require prolonged mechanical
ventilation (PMV)1,2 represent an ever-growing, extremely vulnerable, proportion of intensive
care unit (ICU) survivors.3 The increasing number of these patients is an important factor in
the expanded use of long-term acute care hospitals (LTACHs), centers that specialize in
mechanical ventilation weaning and rehabilitation. The 412 LTACHs currently operated in the
United States admit more than 130,000 patients annually and account for more than $5 billion
in Medicare expenditures each year.4,5 Unfortunately, LTACH stays for patients requiring PMV
are typically complicated and associated with a number of poor outcomes including very high
one-year mortality rates (44-77%),6,7 severe and enduring brain dysfunction (i.e., coma
and/or delirium), life-altering functional decline, substantial pain and suffering, caregiver
burden and diminished quality of life.6-11 While returning home is often an important goal
for patients and their families,3 this is a rare outcome in this population.11 Rather,
patients requiring PMV often experience multiple transitions in care in the year following
their original hospital admission (median of 4), which results in further costs and
persistent, profound disability.9 Despite these disheartening findings, to date there is very
limited scientific evidence available to help clinicians care for the chronically critically
ill, particularly those requiring PMV in LTACHs.

Chronically critically ill patients are generally older, sicker and have more comorbidities
than their acutely ill counterparts.12 Importantly, they also suffer from much greater
symptom burden, with up to 90% of patients experiencing at least one distressing symptom
during the course of their illness (e.g., pain, dyspnea, weakness).13 While these symptoms
are often thought of as unfortunate and inevitable consequences of critical illness,14
evidence suggests that the inappropriate management of these symptoms may actually be causal
to the poor outcomes experienced by this group.15 For example, the results of numerous,
well-designed, clinical trials conducted in the traditional ICU setting by our team and
others suggest regular pain, agitation, and delirium assessment, prevention and treatment,
coupled with strategies that decrease patients' exposure to sedative medications, support
early mobilization, promote evidence-based mechanical ventilation discontinuation approaches,
and actively engage and empower family members in patient care can positively affect
important patient-centered outcomes (e.g., improved survival and physical/cognitive
ability).16-26 One unifying method of implementing these evidence based interventions into
everyday practice is consistent and reliable use of the ABCDEF bundle (i.e., Assess, prevent,
and manage pain, Both Spontaneous Awakening Trials (SATs) & Spontaneous Breathing Trials
(SBTs), Choice of analgesia and sedation, Delirium assess, prevent, and manage, Early
mobility and exercise, and Family engagement and empowerment).27 Congruent with the Society
of Critical Care Medicine's Clinical Practice Guidelines for the Management of Pain,
Agitation, and Delirium and endorsed by a number of patient safety and quality organizations
including the Institute for Healthcare Improvement and the Gordon and Betty Moore Foundation,
the ABCDEF bundle is being actively implemented in ICUs throughout the world. The strength of
evidence supporting the ABCDEF bundle, coupled with this strong implementation momentum, has
prompted interest in the LTACH in applying the bundle into the everyday care of chronically
critically ill patients who require mechanical ventilation.

Select Specialty, a national network of more than 100 LTACHs across the United States, has
expressed the desire to adopt the ABCDEF bundle as a "standard of care" for its patients. As
part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement
project in one of its local hospitals. The overall purpose of this before-after study is to
study prospectively the process and effects of implementing the ABCDEF bundle into the
everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.
Specifically the study's aims are to:

Aim 1: Identify facilitators and barriers to successful ABCDEF bundle implementation in the
LTACH setting.

Aim 2: Compare the symptom experience (e.g., pain, agitation, anxiety, fatigue, shortness of
breath, restlessness, sadness, hunger, fear, thirst, confusion sedative medication exposure)
of patients receiving usual LTACH care (during months 1-4.5) to those treated with the ABCDEF
bundle (during months 4.5-9).

Aim 3. Evaluate the impact ABCDEF bundle implementation has on safety (i.e., new pneumonias,
device self-removal) and patient-centered outcomes (i.e., delirium/coma free days, weaning
duration, tracheostomy removal , mortality, depression, post-traumatic stress disorder,
functional and cognitive ability, discharge disposition, opioid and benzodiazepine withdrawal
rates, and quality of life) of patients receiving usual LTACH care (during months 1-4.5) to
those treated with the ABCDEF bundle (during months 4.5-9).

To complete these aims the investigators will administer an on-line survey and conduct focus
group interviews with LTACH staff before and after the ABCDEF bundle is implemented into
everyday care. Over the course of a nine month period, the investigators will also consent
and enroll 81 patients who require mechanical ventilation at the time of LTACH admission.
These patients will undergo daily, in-person symptom assessment using valid and reliable
screening tools. Finally, medical record reviews and brief patient interviews will be
conducted to obtain data on our outcomes of interest.

Aim 1:

Inclusion • All full and part-time Registered Nurses, attending physicians, respiratory
therapists, pharmacists, and physical/occupational/speech therapists who regularly care for
patients requiring prolonged mechanical ventilation in the LTACH setting

Exclusion

• None

Aims 2 and 3:

Inclusion

- >18 years old

- Admitted to the LTACH with a tracheostomy

- Require mechanical ventilation > 8 hours a day upon LTACH admission

- English speaking

Exclusion Criteria:

- Severe neurologic deficits defined as coma (i.e., Richmond Agitation Sedation Score <
-4 or -5 due to stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic
brain injury, or cerebral edema)

- Inability to obtain informed consent from the patient's legally authorized
representative (LAR) within 72 hours of meeting all inclusion criteria

- Chronic ventilator dependence that is deemed "not weanable" by admitting LTACH
physician.