Intensive Communication for Chronically Critically Ill

Critical Care Clinical Trial

Official title:

Intensive Communication for Chronically Critically Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057238
• Other study ID #: RO1NR8941
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: July 25, 2016
• Start date: November 2005
• Est. completion date: May 2008

Study information

• Verified date: July 2016
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Care
• Critical Illness

Intervention

Other:
• Intensive Communication System
Regular family meetings once a week, using a standard protocol

Locations

Country	Name	City	State
United States	University Hosptials Case Medical center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay and depression		ICU admission, Day 5, discharge, and 2 months	No