ICU Family Communication Study

NCT00720200 | Completed Phase 3 DMC

• 2 other identifiers: 33584-C2R01NR005226
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.

Conditions

Depression; Depressive Symptoms; Anxiety; Stress Disorders, Post-Traumatic; ICU Hospitalization; Care and Treatment in ICU

Keywords

Communication; Intensive Care Units; Palliative Care; End-of-Life Issues; Talking with Your Doctor; Coping with Chronic Illness

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionaire (PHQ-9)

  Family symptoms of depression after the patient dies or is discharged from ICU as assessed by a survey

  At 3- and 6- months following the death of the patient

Secondary Outcomes (8)

• Post-Traumatic Stress Disorder Checklist (PCL)

  At 3- and 6- months following the death of the patient

• Generalized Anxiety Disorder (GAD-7) Survey

  At 3- and 6- months following the death of the patient

• Quality of Dying and Death Questionaire

  Following death of patient

• Evaluate length of stay in ICU/hospital

  During hospital stay

• Costs during ICU stay including estimated costs of intervention

  During ICU length of stay

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Facilitator-Based intervention

2

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Facilitator-Based intervention BEHAVIORAL

Family Members receiving facilitator-based intervention

1

Usual Care BEHAVIORAL

Family Members receiving usual care/clinical interaction

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, family members, clinicians attending ICU family conferences, and nurses evaluating the quality of care.
• All ICU patients are eligible if they meet the age criteria, have been in the ICU for at least 12 hours, have acute respiratory failure requiring mechanical ventilation at the time of enrollment, and have an APACHE II score/SOFA score or other diagnosis that predicts a 30-50% or greater risk of mortality.
• Eligible family members and/or friends may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends; if they meet the age criteria, and understand English well enough to complete informed consent and study materials.
• Eligible clinicians include those who are present during a family conference and may include physicians, nurses, nurse practitioners, physician assistants, social workers, respiratory therapists, and clergy.
• All critical care nurses are eligible to participate in the evaluation if they have provided care to a patient on or before the shift in which he or she died or was discharged from the ICU.

You may not qualify if:

• Legal or risk management concerns (as determined by the attending physician or via hospital record designation);
• Psychological illness or morbidity; and
• Physical or mental limitations preventing ability to complete questionnaires.
• Patients will be excluded if they do not have at least one family member who is eligible and willing to participate in the study.
• A patient who is readmitted to the ICU, if the patient was enrolled and discharged previously, will not be eligible.
• Post-operative patients who have been admitted to the ICU after a scheduled surgery without complications will be excluded. These patients may meet other eligibility criteria (ventilation, APACHE scores, etc.) within the first 12 to 48 hours of admission, but will usually improve quite rapidly after that period.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Valley Medical Center

Renton, Washington, 98058, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Curtis JR, Ciechanowski PS, Downey L, Gold J, Nielsen EL, Shannon SE, Treece PD, Young JP, Engelberg RA. Development and evaluation of an interprofessional communication intervention to improve family outcomes in the ICU. Contemp Clin Trials. 2012 Nov;33(6):1245-54. doi: 10.1016/j.cct.2012.06.010. Epub 2012 Jul 6.

  PMID: 22772089 BACKGROUND

• Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, Khandelwal N, Young JP, Engelberg RA. Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care. Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. doi: 10.1164/rccm.201505-0900OC.

  PMID: 26378963 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Communication

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• J. Randall Curtis, MD, MPH

  University of Washington, Division of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

• Ruth A Engelberg, PhD

  University of Washington, Division of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (2)