Clinical trial NCT01982877: The Four Supports Study: Family Support Intervention in Intensive Care Units
Official title: A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Intensive Care Unit Patients
Physician-Family Communication in Intensive Care Units
Surrogate Decision-making for Critically Ill Patients
Keywords: decision making
values elicitation
patient centered care
Four Supports
Family Support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-11-13
Enrollment: 546
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

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).

Eligibility criteria: Patient Inclusion criteria:

1. age ≥21,
2. lack of decision making capacity as determined by clinical examination by the attending physician,
3. APACHE II score ≥ 22, AND/OR
4. \> 40% risk of death in hospital or \>40% chance of severe long term functional impairment as judged by the patient's attending physician.

Patient Exclusion Criteria:

1. lack of a surrogate decision maker and
2. impending organ transplantation.
3. decisions regarding care and treatment already made
4. not currently participating in competing research study
5. Discharged prior to enrollment
6. Incarcerated.

Surrogate Inclusion criteria:

1. age ≥ 18 years,
2. self-identify as being involved in surrogate decision-making for the patient, up to a total of four family/surrogates.
3. able to give full informed consent, and
4. able to complete written questionnaires.

Surrogate Exclusion Criteria:

1. age \<18 years old,
2. unable to read and understand English, and
3. unable to complete questionnaires due to physical or cognitive limitations.

Physician Inclusion criteria:

1) 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:

1) Study investigators will be excluded as participants.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: participants will be followed six months following the patient's death or discharge from hospital, an expected average of 195 days
Secondary outcomes:
measure: Patient and family-centeredness of care
timeFrame: At 6 months
measure: Total Hospital Costs
timeFrame: Duration of hospital stay, an expected average of 4 weeks
measure: Intensive Care Unit Length of Stay
timeFrame: Participants will be followed for duration of ICU stay, an expected average of 21 days
measure: Hospital Length of stay
timeFrame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks
measure: Impact of Events scale at 6 months
timeFrame: at 6 months
Other outcomes:
measure: Concordance between clinicians and surrogates about patient's prognosis (CSCS)
timeFrame: Participants are followed at time of enrollment, on day 5 of enrollment, and weekly thereafter for the duration of the hospital stay, an expected average of 4 weeks
measure: Decisional Conflict Scale (DCS)
timeFrame: Participants are followed at time of enrollment and on day 5 of enrollment
measure: Quality of Communication Scale
timeFrame: Day 5 of enrollment
measure: Impact of Events Scale
timeFrame: at 3 months
measure: Inventory of Complicated Grief
timeFrame: At 3 months and at 6 months
measure: Utilization of Mental Health Treatment
timeFrame: At 3 months and 6 months
measure: Activity of Daily Living
timeFrame: At 6 months
measure: Vital Status
timeFrame: At 6 months
measure: Discharge Dispensation
timeFrame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks
measure: HADS
timeFrame: at 3 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Seaman JB, Arnold RM, Buddadhumaruk P, Shields AM, Gustafson RM, Felman K, Newdick W, SanPedro R, Mackenzie S, Morse JQ, Chang CH, Happ MB, Song MK, Kahn JM, Reynolds CF 3rd, Angus DC, Landefeld S, White DB. Protocol and Fidelity Monitoring Plan for Four Supports. A Multicenter Trial of an Intervention to Support Surrogate Decision Makers in Intensive Care Units. Ann Am Thorac Soc. 2018 Sep;15(9):1083-1091. doi: 10.1513/AnnalsATS.201803-157SD.