NCT01230099

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

4 years

First QC Date

October 22, 2010

Last Update Submit

October 28, 2015

Conditions

Chronic Critical IllnessProlonged Mechanical Ventilation

Keywords

Critical IllnessMechanical VentilationPalliative CareCaregivers

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale

    Day 90

Secondary Outcomes (11)

  • Hospital Anxiety and Depression Scale

    Day 18-20

  • Impact of Events Scale-Revised

    Day 90

  • Discussion of Preferences for Patients Goals of Care

    Day 18-20

  • Quality of Communication

    Day 18-20

  • Family Satisfaction in the Intensive Care Unit (ICU) Survey

    Day 90

  • +6 more secondary outcomes

Study Arms (2)

Supportive Information Team Group

EXPERIMENTAL

Protocolized information and support meetings led by palliative care clinicians

Behavioral: Supportive Information Team Group

Usual Care Group

NO INTERVENTION

Interventions

Supportive Information Team GroupBEHAVIORAL

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.

Also known as: SIT
Supportive Information Team Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Durham Regional Medical Center

Durham, North Carolina, 27704, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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.

    PMID: 28387538DERIVED

  • 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. doi: 10.1001/jama.2017.4298.

    PMID: 27380343DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith Nelson, MD, JD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Shannon Carson, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 28, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

US(4)