Intensive Communication for Chronically Critically Ill

NCT ID: NCT01057238

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Critical Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intensive Communication

regular family meeting every 5 days.

Group Type EXPERIMENTAL

Intensive Communication System

Intervention Type OTHER

Regular family meetings once a week, using a standard protocol

Control

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Communication System

Regular family meetings once a week, using a standard protocol

Intervention Type OTHER

Other Intervention Names

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Intervention arm

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Barbara J. Daly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara J Daly, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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University Hosptials Case Medical center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20576734 (View on PubMed)

Other Identifiers

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R01NR008941

Identifier Type: NIH

Identifier Source: org_study_id

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