Intensive Communication for Chronically Critically Ill
Primary Purpose
Critical Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Communication System
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Care focused on measuring mechanical ventilation, critical care
Eligibility Criteria
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
Sites / Locations
- University Hosptials Case Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive Communication
Control
Arm Description
regular family meeting every 5 days.
usual care
Outcomes
Primary Outcome Measures
length of stay and depression
Secondary Outcome Measures
Full Information
NCT ID
NCT01057238
First Posted
January 26, 2010
Last Updated
July 25, 2016
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT01057238
Brief Title
Intensive Communication for Chronically Critically Ill
Official Title
Intensive Communication for Chronically Critically Ill
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Care
Keywords
mechanical ventilation, critical care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
571 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Communication
Arm Type
Experimental
Arm Description
regular family meeting every 5 days.
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
Intensive Communication System
Other Intervention Name(s)
Intervention arm
Intervention Description
Regular family meetings once a week, using a standard protocol
Primary Outcome Measure Information:
Title
length of stay and depression
Time Frame
ICU admission, Day 5, discharge, and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Daly, PhD, RN
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hosptials Case Medical center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20576734
Citation
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.
Results Reference
derived
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Intensive Communication for Chronically Critically Ill
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