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

Brief Summary:
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.

Condition or disease Intervention/treatment
Critical Care Other: Intensive Communication System

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intensive Communication for Chronically Critically Ill
Study Start Date : November 2005
Primary Completion Date : April 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intensive Communication
regular family meeting every 5 days.
Other: Intensive Communication System
Regular family meetings once a week, using a standard protocol
Other Name: Intervention arm
No Intervention: Control
usual care

Primary Outcome Measures :
  1. length of stay and depression [ Time Frame: ICU admission, Day 5, discharge, and 2 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057238

United States, Ohio
University Hosptials Case Medical center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Principal Investigator: Barbara J Daly, PhD, RN Case Western Reserve University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barbara J. Daly, Principal Investigator, Case Western Reserve University Identifier: NCT01057238     History of Changes
Other Study ID Numbers: R01NR008941 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Keywords provided by Barbara J. Daly, Case Western Reserve University:
mechanical ventilation
critical care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes