Intensive Communication for Chronically Critically Ill

This study has been completed.
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01057238
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 26, 2010
January 26, 2010
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
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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
No Intervention: Control usual care
usual care and communication
Intervention: Other: Intensive Communication System
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. 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057238
RO1NR8941
Yes
Barbara 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
January 2010

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