Intensive Communication for Chronically Critically Ill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057238
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):
Barbara J. Daly, Case Western Reserve University

January 26, 2010
January 27, 2010
July 27, 2016
November 2005
April 2008   (Final data collection date for primary outcome measure)
length of stay and depression [ Time Frame: ICU admission, Day 5, discharge, and 2 months ]
Same as current
Complete list of historical versions of study NCT01057238 on Archive Site
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Intensive Communication for Chronically Critically Ill
Intensive Communication for Chronically Critically Ill
This study was a trial of a formal system of family meetings to support family decision makers of chronically critically ill patients in the intensive care unit.

Formal family meetings have been recommended as a useful approach to assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the ICU. We implemented an "intensive communication system" to test the effect of regular, structured formal family meetings on patient outcomes among long-stay ICU patients

The design was a pre-post, tandem assignment of patients (n=217) receiving usual care and communication, followed by enrollment of intervention patients (n=354), from 5 ICUs. The "intensive communication system" included: (1) family meeting within 5 days of ICU admission and weekly thereafter; (2) each meeting addressed medical update, values and preferences, goals of care; treatment plan, and milestones for judging effectiveness of treatment.

We measured differences between control and intervention patients in indicators of aggressiveness of care or timing of treatment limitation decisions (ICU mortality, LOS, duration of ventilation, treatment limitation orders, or use of tracheostomy or percutaneous gastrostomy). Difference in outcomes among patients who died or who had treatment limitation orders, comparing control and intervention groups, was also examined.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Critical Care
Other: Intensive Communication System
Regular family meetings once a week, using a standard protocol
Other Name: Intervention arm
  • Experimental: Intensive Communication
    regular family meeting every 5 days.
    Intervention: Other: Intensive Communication System
  • No Intervention: Control
    usual care
Daly BJ, Douglas SL, O'Toole E, Gordon NH, Hejal R, Peerless J, Rowbottom J, Garland A, Lilly C, Wiencek C, Hickman R. Effectiveness trial of an intensive communication structure for families of long-stay ICU patients. Chest. 2010 Dec;138(6):1340-8. doi: 10.1378/chest.10-0292. Epub 2010 Jun 24.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • cognitively impaired mechanical ventilation >3 days not expected to be discharged before 5 days having a family decision maker

Exclusion Criteria:

  • no family member hospice referral
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01NR008941( U.S. NIH Grant/Contract )
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Barbara J. Daly, Case Western Reserve University
Case Western Reserve University
Not Provided
Principal Investigator: Barbara J Daly, PhD, RN Case Western Reserve University
Case Western Reserve University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP