ICU Family Communication Study

Depression Clinical Trial

Official title:

A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720200
• Other study ID #: 33584-C
• Secondary ID: 2R01NR005226
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: September 13, 2014
• Start date: June 2008
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Three decades of research on end-of-life care in the United States indicate that people who are dying often spend their final days receiving care they would not choose. The intensive care unit (ICU) is an important focus for efforts to improve end-of-life care both because death is common in this setting - approximately 20% of Americans die in or shortly after a stay in the ICU - and also because care is highly technologic and, thus, expensive. As a result of our prior work we have developed a wealth of knowledge about how to improve communication and decision-making concerning end-of-life care in the ICU. One of the important insights from this knowledge was the need for and development of a facilitator-assisted interdisciplinary communication intervention. This intervention, designed to improve communication and decision-making about end-of-life care in the ICU, offers significant potential benefits for improving patient- and family-centered care for five reasons: 1) communication is an integral component of clinician skill that affects all other aspects of end-of-life care; 2) physicians and nurses in practice do not demonstrate adequate skills for communicating about end-of-life care, especially in the ICU or acute care setting; 3) interventions that have focused on improving communication within the ICU team and between the team and the family have been shown to reduce the "prolongation of dying" common in the ICU, but it remains unclear how to generalize these successes to other hospitals; 4) a recent randomized trial in France used an intervention based on our prior research and showed dramatic reductions in symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) among family members after the patient's death, but it is unclear how to translate these findings to hospitals in the U.S.; and 5) sustainable, generalizable, and widely available interventions that improve communication about end-of-life care are not available.

The long-term objectives are: 1) to demonstrate the efficacy of a generalizable facilitator-assisted interdisciplinary communication intervention in the ICU to improve family and patient outcomes; and 2) to demonstrate the feasibility of making this intervention a routine part of clinical practice in the ICU setting.

The study will advance Nursing science by addressing an important area of emphasis within Nursing science and a key component of the National Institute of Nursing Research's strategic plan. One fifth of deaths in America occur in intensive care units and nurses provide a key component of the care in this setting. With the aging population and coincident advances in medical technology, more patients are likely to die after an unsuccessful trial of intensive care. Prior research suggests that interventions to improve communication about end-of-life care in the ICU may reduce the prolongation of dying that is common in the ICU setting while at the same time improving the quality of care for patients and family members. Unfortunately, this prior research does not provide a clear generalizable intervention that can be easily implemented in academic and community hospitals. The proposed randomized trial will test a feasible and generalizable intervention to improve communication about end-of-life care and improve patient and family outcomes.

The consent forms used for this study address the purpose, procedures, risks, alternatives, benefits, and other information -- including emphasis on the voluntary nature of this research and assurances of confidentiality.

The conceptual model for the intervention addresses three components of self-efficacy theory: 1) knowledge, based on this team's prior research identifying components of communication during ICU family conferences that are associated with improved patient and family outcomes; 2) attitudes, informed by attachment theory as applied to clinician-patient relationships and communication; and 3) communication behaviors informed by principles of mediation based on identifying and resolving conflict in the healthcare setting.

The intervention includes the following steps: 1) in-person interviews by the facilitator with the family prior to the family conference in order to discuss the family's concerns, questions, needs and unique communication characteristics that will be addressed in the family conference; 2) a pre-conference meeting with the facilitator, physician(s), nurse(s), and other clinicians in which a brief summary describing the family's concerns, questions, needs, and unique communication characteristics is presented and discussed; 3) facilitator participation in the family conference; and 4) facilitator follow up with the family throughout the ICU stay. Prior to the facilitator's involvement, both the intervention and control group will meet with the research coordinator who will obtain consent from the family and distribute baseline questionnaires; the research coordinator will also contact both the intervention and control group families at the time of the follow-up questionnaires (3 and 6 months after discharge or death) to notify them that questionnaires are being sent to them and ask if they have any questions. The contacts through the research coordinator are expected to enhance response rates for both groups. For the control group, these contacts with the research coordinator will provide an "attention control." The research coordinator will not provide any of the other intervention components provided by the facilitator (i.e., discussion of concerns or questions prior to the family conference; brief summary to clinicians; participation in the family conference; follow-up contact after the family conference for duration of the ICU stay). A component of the facilitator's role will also include helping to identify the need for a family conference and scheduling these conferences. Therefore, as part of the multi-faceted intervention, we anticipate that family conferences will occur earlier and more frequently in the intervention arm. After the initial family conference, there may be additional family conferences and the facilitator will participate in these conferences for the intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Facilitator-Based intervention
Family Members receiving facilitator-based intervention
• Usual Care
Family Members receiving usual care/clinical interaction

Locations

Country	Name	City	State
United States	Valley Medical Center	Renton	Washington
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Post-Traumatic Stress Disorder Checklist (PCL)	Symptoms of PTSD	At 3- and 6- months following the death of the patient	No
Secondary	Generalized Anxiety Disorder (GAD-7) Survey	Anxiety	At 3- and 6- months following the death of the patient	No
Secondary	Quality of Dying and Death Questionaire		Following death of patient	No
Secondary	Evaluate length of stay in ICU/hospital		During hospital stay	No
Secondary	Costs during ICU stay including estimated costs of intervention		During ICU length of stay	No
Secondary	Families' ratings of the quality of communication generally and specifically in the family conference		During ICU length of stay	No
Secondary	Clinicians' ratings of the quality of clinician-family in the family conference		During ICU length of stay	No
Secondary	Clinicians' ratings of nurse-physician collaboration		During ICU length of stay	No