NCT01107704

Brief Summary

The purpose of this study is to test the effectiveness of a multi-faceted communication intervention for family members of critically ill patients to reduce the family members' long-term symptoms of depression and anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

April 19, 2010

Last Update Submit

January 23, 2014

Conditions

Physician-Family Communication in Intensive Care UnitsSurrogate Decision-making for Critically Ill Patients

Keywords

Intensive Care UnitsSurrogatesFamily MembersPhysiciansCritically IllDepressionAnxietyEmotionalSupportMulti-faceted communicationGriefPrognosisFamily Support Counselor

Outcome Measures

Primary Outcomes (2)

  • Family Outcome: Family members' depressive symptoms

    Three months following patient death or discharge from the ICU.

  • Patient Outcome: Patient centeredness of care

    Three months following patient death or discharge from the ICU.

Study Arms (2)

Family Support Intervention

EXPERIMENTAL
Behavioral: Family Support Intervention

Control Group

NO INTERVENTION

Interventions

Family Support InterventionBEHAVIORAL

Multifaceted family support intervention

Family Support Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be unable to make treatment decisions for him/herself, as determined by the patient's physicians.
  • must have have either an APACHE II score of ≥ 25 or, for patients with a primary neurologic diagnosis (e.g. intracranial hemorrhage, subdural hemorrhage, or subarachnoid hemorrhage), physician estimate that the patient has at least a 50% risk of long term, severe functional impairment
  • must be 50 years old or greater.

You may not qualify if:

  • Patients who do not have surrogates or at least one family member who is willing to participate in the study.
  • Patients awaiting organ transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

MeSH Terms

Conditions

Critical IllnessDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Douglas B. White, MD, MAS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

US(1)