A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 546
- Locations
- 1
- Primary Endpoint
- Hospital Anxiety and Depression Scale
Study Overview
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.
Detailed Description
One in four elderly Americans die in or shortly after discharge from an intensive care unit. An expanding body of literature documents that physician-family communication and end-of-life care is poor in intensive care units. These deficiencies are associated with high rates of adverse psychological outcomes among surrogates, physician-family conflict, and life support decisions that may be inconsistent with patients' goals and preferences. There is a lack of information on practical, generalizable interventions that effectively improve this important aspect of care for elderly patients and their families.
The primary aim of this study is to evaluate the effectiveness of a multifaceted communication intervention as compared to an educational control to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.
This randomized controlled trial involves adding a Family Support Specialist (FSS) to the clinical team to provide four types of support to the families of patients with advanced critical illness: emotional support, communication support (between the clinical team and the family), decisional support (education about the role of a surrogate decision maker) and anticipatory grief support.
The overall aim of the study is to improve the long-term psychological outcomes for family members of critically ill patients, to improve the quality of communication and decision-making between physicians and families, and to improve the patient-centeredness of care.
What happens in the study?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient Inclusion criteria:
- •lack of decision making capacity as determined by clinical examination by the attending physician,
- •APACHE II score ≥ 22, AND/OR
- •> 40% risk of death in hospital or >40% chance of severe long term functional impairment as judged by the patient's attending physician.
Exclusion Criteria
- •lack of a surrogate decision maker and
- •impending organ transplantation.
- •decisions regarding care and treatment already made
- •not currently participating in competing research study
- •Discharged prior to enrollment
- •Incarcerated.
- •Surrogate Inclusion criteria:
- •age ≥ 18 years,
- •self-identify as being involved in surrogate decision-making for the patient, up to a total of four family/surrogates.
- •able to give full informed consent, and
- •able to complete written questionnaires.
- •Surrogate Exclusion Criteria:
- •age <18 years old,
- •unable to read and understand English, and
- •unable to complete questionnaires due to physical or cognitive limitations.
- •Physician Inclusion criteria:
- •Eligible physicians will be the patient's primary attending or his/her designee. If an enrolled patient is cared for by more than one attending physician during their ICU stay, each will be consented.
- •Physician Exclusion Criteria:
- •Study investigators will be excluded as participants.
Arms & Interventions
Family Support Intervention
Multifaceted family support intervention as well as ICU educational component.
Intervention: Four Supports Intervention (Behavioral)
Family Support Intervention
Multifaceted family support intervention as well as ICU educational component.
Intervention: Educational Control Intervention (Behavioral)
Educational Control
ICU educational component
Intervention: Educational Control Intervention (Behavioral)
Outcomes
Primary Outcomes
Hospital Anxiety and Depression Scale
Time Frame: participants will be followed six months following the patient's death or discharge from hospital, an expected average of 195 days
Burden of anxiety and depression will be measured in family members 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS).
Secondary Outcomes
- Hospital Length of stay(Participants will be followed for duration of hospital stay, an expected average of 4 weeks)
- Patient and family-centeredness of care(At 6 months)
- Impact of Events scale at 6 months(at 6 months)
- Intensive Care Unit Length of Stay(Participants will be followed for duration of ICU stay, an expected average of 21 days)
- Total Hospital Costs(Duration of hospital stay, an expected average of 4 weeks)
Investigators
Douglas White
MD, MAS Vice Chair and Professor of Critical Medicine
University of Pittsburgh