NCT01057238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

January 26, 2010

Last Update Submit

July 25, 2016

Conditions

Critical Care

Keywords

mechanical ventilationcritical care

Outcome Measures

Primary Outcomes (1)

  • length of stay and depression

    ICU admission, Day 5, discharge, and 2 months

Study Arms (2)

Intensive Communication

EXPERIMENTAL

regular family meeting every 5 days.

Other: Intensive Communication System

Control

NO INTERVENTION

usual care

Interventions

Intensive Communication SystemOTHER

Regular family meetings once a week, using a standard protocol

Also known as: Intervention arm
Intensive Communication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cognitively impaired mechanical ventilation \>3 days not expected to be discharged before 5 days having a family decision maker

You may not qualify if:

  • no family member hospice referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hosptials Case Medical center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 20576734DERIVED

Study Officials

  • Barbara J Daly, PhD, RN

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

November 1, 2005

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

US(1)