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
  Purpose

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 Intervention
Critical Care
Other: Intensive Communication System

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intensive Communication for Chronically Critically Ill

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • length of stay and depression [ Time Frame: ICU admission, Day 5, discharge, and 2 months ] [ Designated as safety issue: No ]

Enrollment: 571
Study Start Date: November 2005
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control usual care
usual care and communication
Other: Intensive Communication System
Regular family meetings once a week, using a standard protocol
Other Name: Intervention arm

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057238

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

No publications provided by Case Western Reserve University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Daly, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01057238     History of Changes
Other Study ID Numbers: RO1NR8941
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
mechanical ventilation
critical care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014