Intensive Communication for Chronically Critically Ill
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2010 | ||||
| Last Updated Date | January 26, 2010 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
length of stay and depression [ Time Frame: ICU admission, Day 5, discharge, and 2 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intensive Communication for Chronically Critically Ill | ||||
| Official Title ICMJE | Intensive Communication for Chronically Critically Ill | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Critical Care | ||||
| Intervention ICMJE | Other: Intensive Communication System
Regular family meetings once a week, using a standard protocol
Other Name: Intervention arm |
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| Study Arm (s) | No Intervention: Control usual care
usual care and communication
Intervention: Other: Intensive Communication System |
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| Publications * | 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. Epub 2010 Jun 24. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 571 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01057238 | ||||
| Other Study ID Numbers ICMJE | RO1NR8941 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Barbara Daly, Case Western Reserve University | ||||
| Study Sponsor ICMJE | Case Western Reserve University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Case Western Reserve University | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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