Clinical trial NCT01230099: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Official title: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Critical Illness
Prolonged Mechanical Ventilation
Keywords: Critical Illness
Mechanical Ventilation
Palliative Care
Caregivers
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University of North Carolina
name: Duke University
First posted: 2010-10-28
Enrollment: 622
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.

Detailed description: 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 ≥ 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 Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is 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.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated ≥ 7 days
* Mechanically ventilated without \> 96 hour interruption
* Age ≥ 21 years
* ICU MD does not expect patient will die within 72 hours
* ICU MD does not expect patient will be liberated from the ventilator within 72 hours.

Exclusion Criteria:

* Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for \> 7 days before transfer
* Chronic Neuromuscular (NM) Disease
* Trauma
* Burn
* Previous palliative care consultation in this hospitalization
* No family or other surrogate decision-maker
* Family not available
* Surrogate lacks English proficiency
* Physician refused permission for research staff to approach the family

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Day 90
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Day 18-20
measure: Impact of Events Scale-Revised
timeFrame: Day 90
measure: Discussion of Preferences for Patients Goals of Care
timeFrame: Day 18-20
measure: Quality of Communication
timeFrame: Day 18-20
measure: Family Satisfaction in the Intensive Care Unit (ICU) Survey
timeFrame: Day 90
measure: Modified Center for Gerontology and Health Care Research (CHCR) Tool
timeFrame: Day 90
measure: Limitation of Intensive Care Unit (ICU) Therapy
timeFrame: Average of 60 days
measure: Hospital Length of Stay
timeFrame: Average of 60 days
measure: Mortality
timeFrame: Day 90
measure: Physician-Surrogate Discordance Score
timeFrame: day 18-20
measure: Discussion of Preferences for Patients Goals of Care
timeFrame: Day 90
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Durham
country: United States
facility: Durham Regional Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Judith Nelson, MD, JD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Shannon Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
citation: Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474.