Intensive Communication for Chronically Critically Ill

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbara J. Daly, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01057238
First received: January 26, 2010
Last updated: July 25, 2016
Last verified: July 2016

January 26, 2010
July 25, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057238 on ClinicalTrials.gov 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.

Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
571
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057238
RO1NR8941
Yes
Not Provided
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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