Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)

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

Study Overview

• Status: Completed
• Conditions: Chronic Critical Illness; Prolonged Mechanical Ventilation
• Intervention / Treatment: Behavioral: Supportive Information Team Group

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.

• Study Type: Interventional
• Enrollment (Actual): 622
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina School of Medicine
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine
    • Durham, North Carolina, United States, 27704
      • Durham Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group
Experimental: Supportive Information Team Group; Protocolized information and support meetings led by palliative care clinicians	Behavioral: Supportive Information Team Group; A minimum of two protocolized, interdisciplinary, informational support meetings led by palliative care clinicians will be arranged with family members or other patient surrogates who participate in decision-making for individual chronically critically ill patients.; Other Names: SIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Anxiety and Depression Scale	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		Day 90
Hospital Anxiety and Depression Scale		Day 18-20
Impact of Events Scale-Revised		Day 90
Discussion of Preferences for Patients Goals of Care	Subscale of Center for Gerontology and Health Care Research Toolkit	Day 18-20
Quality of Communication	Curtis Measure	Day 18-20
Family Satisfaction in the Intensive Care Unit (ICU) Survey		Day 90
Modified Center for Gerontology and Health Care Research (CHCR) Tool		Day 90
Limitation of Intensive Care Unit (ICU) Therapy	Percent of patients with mechanical ventilation, renal replacement, vasopressors, or artificial nutrition withheld or withdrawn	Average of 60 days
Hospital Length of Stay	Days since randomization	Average of 60 days
Physician-Surrogate Discordance Score		day 18-20
Discussion of Preferences for Patients Goals of Care	Subscale of Center for Gerontology and Health Care Research Toolkit	Day 90

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Nursing Research (NINR); Duke University; University of North Carolina
• Investigators: Principal Investigator: Judith Nelson, MD, JD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: JAMA. 2017 May 23;317(20):2134.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Palliative Care; Critical Illness; Mechanical Ventilation; Caregivers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 08-0601 0001 01 ME; R01NR012413-01A1 (U.S. NIH Grant/Contract)