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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
University of North Carolina
Duke University
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01230099
First received: October 22, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Chronic Critical Illness
Prolonged Mechanical Ventilation
Behavioral: Supportive Information Team Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]
  • Impact of Events Scale-Revised [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Discussion of Preferences for Patients Goals of Care [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]
    Subscale of Center for Gerontology and Health Care Research Toolkit

  • Quality of Communication [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]
    Curtis Measure

  • Family Satisfaction in the Intensive Care Unit (ICU) Survey [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Modified Center for Gerontology and Health Care Research (CHCR) Tool [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Limitation of Intensive Care Unit (ICU) Therapy [ Time Frame: Average of 60 days ] [ Designated as safety issue: No ]
    Percent of patients with mechanical ventilation, renal replacement, vasopressors, or artificial nutrition withheld or withdrawn

  • Hospital Length of Stay [ Time Frame: Average of 60 days ] [ Designated as safety issue: No ]
    Days since randomization

  • Mortality [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • Physician-Surrogate Discordance Score [ Time Frame: day 18-20 ] [ Designated as safety issue: No ]
  • Discussion of Preferences for Patients Goals of Care [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Subscale of Center for Gerontology and Health Care Research Toolkit


Estimated Enrollment: 620
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SIT
No Intervention: Usual Care 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230099

Contacts
Contact: Yanoh K Jalloh, MPH 212-241-7258 Yanoh.Jalloh@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Yanoh K Jalloh, MPH    212-241-7258    Yanoh.Jalloh@mssm.edu   
Principal Investigator: Judith Nelson, MD, JD         
United States, North Carolina
University of North Carolina School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Joyce Lanier    919-966-2531    joyce_lanier@med.unc.edu   
Principal Investigator: Shannon Carson, MD         
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Cox, MD    919-681-7232    christopher.cox@duke.edu   
Principal Investigator: Christopher Cox, MD         
Durham Regional Medical Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Christopher Cox, MD    919-681-7232    christopher.cox@duke.edu   
Principal Investigator: Christopher Cox, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
University of North Carolina
Duke University
Investigators
Principal Investigator: Judith Nelson, MD, JD Mount Sinai School of Medicine
Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01230099     History of Changes
Other Study ID Numbers: 08-0601 0001 01 ME, R01NR012413-01A1
Study First Received: October 22, 2010
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Critical Illness
Mechanical Ventilation
Palliative Care
Caregivers

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014