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

NCT01982877 | Completed DMC

• 1 other identifier: 1R01AG045176-01
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  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).

  participants will be followed six months following the patient's death or discharge from hospital, an expected average of 195 days

Secondary Outcomes (5)

• Patient and family-centeredness of care

  At 6 months

• Total Hospital Costs

  Duration of hospital stay, an expected average of 4 weeks

• Intensive Care Unit Length of Stay

  Participants will be followed for duration of ICU stay, an expected average of 21 days

• Hospital Length of stay

  Participants will be followed for duration of hospital stay, an expected average of 4 weeks

• Impact of Events scale at 6 months

  at 6 months

Other Outcomes (10)

• Concordance between clinicians and surrogates about patient's prognosis (CSCS)

  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

• Decisional Conflict Scale (DCS)

  Participants are followed at time of enrollment and on day 5 of enrollment

• Quality of Communication Scale

  Day 5 of enrollment

Study Arms (2)

Family Support Intervention

EXPERIMENTAL

Multifaceted family support intervention as well as ICU educational component.

Behavioral: Four Supports Intervention; Behavioral: Educational Control Intervention

Educational Control

EXPERIMENTAL

ICU educational component

Behavioral: Educational Control Intervention

Interventions

Four Supports Intervention BEHAVIORAL

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.

Family Support Intervention

Educational Control Intervention BEHAVIORAL

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.

Educational Control; Family Support Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥21,
• 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.

You may not qualify if:

• 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.
• 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.
• age \<18 years old,
• unable to read and understand English, and
• unable to complete questionnaires due to physical or cognitive limitations.
• \) 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.
• \) Study investigators will be excluded as participants.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15216, United States

Location

Related Publications (2)

• Butler RA, Seaman JB, Felman K, Stonehouse W, San Pedro R, Morse JQ, Chang CH, Lincoln T, Reynolds CF 3rd, Landefeld S, Happ MB, Song MK, Angus DC, Arnold RM, White DB. Randomized Clinical Trial of the Four Supports Intervention for Surrogate Decision-Makers in Intensive Care Units. Am J Respir Crit Care Med. 2025 Mar;211(3):370-380. doi: 10.1164/rccm.202405-0931OC.

  PMID: 39586017 DERIVED

• 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.

  PMID: 30088971 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MAS Vice Chair and Professor of Critical Medicine

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 13, 2013
• Study Start: January 1, 2014
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (1)