Critically Ill Intensive Care Unit PatientsNCT01982877
The Four Supports Study: Family Support Intervention in Intensive Care Units
A study testing Four Supports Intervention in people with Critically Ill Intensive Care Unit Patients and Physician-Family Communication in Intensive Care Units, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critically Ill Intensive Care Unit Patients, Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients
- What is being tested?
- Four Supports Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 19 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion criteria:
- 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.
Patient 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15216
About this study
Official title: A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults
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.
Read the 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:
- 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.
- 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
- Being tested
- Four Supports Intervention, Educational Control Intervention
- Keywords
- decision making, values elicitation, patient centered care, Four Supports, Family Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Supports InterventionBehavioural
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.
Educational Control InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Support Intervention | Experimental | Multifaceted family support intervention as well as ICU educational component. Receives: Behavioral: Four Supports Intervention; Behavioral: Educational Control Intervention |
| Educational Control | Experimental | ICU educational component Receives: Behavioral: Educational Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Patient and family-centeredness of care measured using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted to use by surrogates.
Measured: At 6 months
Total Hospital Costs
he costs are measured using aggregate data form the date of hospital admission through hospital discharge
Measured: Duration of hospital stay, an expected average of 4 weeks
Intensive Care Unit Length of Stay
The Intensive Care Unit length of stay , assessed by abstraction from hospital administrative records
Measured: Participants will be followed for duration of ICU stay, an expected average of 21 days
Hospital Length of stay
Hospital length of stay length of stay , assessed by abstraction from hospital administrative records
Measured: Participants will be followed for duration of hospital stay, an expected average of 4 weeks
Impact of Events scale at 6 months
Symptoms of post traumatic stress in family members assessed using the validated 22 item Impact of Events Scale.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Intensive Care Unit PatientsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Douglas White, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982877
- Sponsor's protocol ID
- 1R01AG045176-01
- Status last verified
- Jan 2020
- First submitted
- 30 Oct 2013
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39586017Seaman 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.
PubMed 30088971
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults
- ClinicalTrials.gov ID
- NCT01982877
- Acronym / sponsor ID
- 1R01AG045176-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2014 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Support Intervention | Experimental | Behavioral: Four Supports Intervention, Behavioral: Educational Control InterventionMultifaceted family support intervention as well as ICU educational component. |
| Educational Control | Experimental | Behavioral: Educational Control InterventionICU educational component |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four Supports InterventionThe 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. | Behavioural | Family Support Intervention |
| Educational Control InterventionIn 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. | Behavioural | Educational Control, Family Support Intervention |
Primary outcome
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).
5 secondary outcomes
Patient and family-centeredness of care
Time frame: At 6 months
Total Hospital Costs
Time frame: Duration of hospital stay, an expected average of 4 weeks
Intensive Care Unit Length of Stay
Time frame: Participants will be followed for duration of ICU stay, an expected average of 21 days
Hospital Length of stay
Time frame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks
Impact of Events scale at 6 months
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 39586017Butler 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.
- Derived from this study: PubMed 30088971Seaman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four Supports Intervention in people with Critically Ill Intensive Care Unit Patients and Physician-Family Communication in Intensive Care Units, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.