NCT01982877

The Four Supports Study: Family Support Intervention in Intensive Care Units

A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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? Patient is randomized to one of two groups: 1. INTERVENTION GROUP: Family Support Specialist is added to the clinical team to provide emotional support to the family and facilitate frequent communication with the clinical team. 2. CONTROL GROUP: Receives usual care with the addition of two educational sessions provided by the FSS to teach family members about the ICU environment. What do participants need to do? Family Members: Interact with the Family Support Specialist daily. Family Support Specialist addresses family needs and ensures that their questions are addressed. Physicians: Collaborate with the Family Support Specialist to determine how best to support the family as well as attending clinician-family meetings. Sample size: With a sample size of 300 patients (450 surrogates), the study is well powered to detect small and clinically important differences in the primary outcome measure Hospital Anxiety and Depression Score (HADS).The trial's original sample size of 400 patients (600 surrogates) was chosen to maximize the power to detect differences in a secondary outcome measure (costs) that required a substantially larger sample size than the primary outcome (HADS). Since the original power calculations were conducted, new data were published which indicated that cost analysis in this context will require an even larger sample size based one effect modification from whether the patient lived or died. Therefore, the Data and Safety Monitoring Board recommended revising the sample size to power the trial on the primary outcome (HADS), which required 300 patients (450 surrogates).

Conditions

• Critically Ill Intensive Care Unit Patients
• Physician-Family Communication in Intensive Care Units
• Surrogate Decision-making for Critically Ill Patients

Interventions

Type	Name	Description
BEHAVIORAL	Four Supports Intervention	The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse/social worker interventionist to the patient's care team who delivers four kinds of support: emotional support, communication support, decision support, and anticipatory grief support.
BEHAVIORAL	Educational Control Intervention	In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-04-19
• Completion: 2019-04-19
• First posted: 2013-11-13
• Last updated: 2020-01-14

Locations

1 site across 1 country: United States