Physician-Family Communication in Intensive Care UnitsNCT01107704
Family Support Intervention in Intensive Care Units (The Four Supports Study)
A study testing Family Support Intervention in people with Physician-Family Communication in Intensive Care Units and Surrogate Decision-making for Critically Ill Patients, 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 50 years and older
- Conditions the study is for
- Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients
- What is being tested?
- Family Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be unable to make treatment decisions for him/herself, as determined by the patient's physicians.
- must have have either an APACHE II score of ≥ 25 or, for patients with a primary neurologic diagnosis (e.g. intracranial hemorrhage, subdural hemorrhage, or subarachnoid hemorrhage), physician estimate that the patient has at least a 50% risk of long term, severe functional impairment
- must be 50 years old or greater.
Who cannot join
- Patients who do not have surrogates or at least one family member who is willing to participate in the study.
- Patients awaiting organ transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213-2582
About this study
Official title: A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.
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 on 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 to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.
- Conditions
- Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients
- Being tested
- Family Support Intervention
- Keywords
- Intensive Care Units, Surrogates, Family Members, Physicians, Critically Ill, Depression, Anxiety, Emotional, Support, Multi-faceted communication, Grief, Prognosis, Family Support Counselor
- Medical subject headings
- Critical Illness, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Support InterventionBehavioural
Multifaceted family support intervention
| Study group | Role | What they receive |
|---|---|---|
| Family Support Intervention | Experimental | Not described Receives: Behavioral: Family Support Intervention |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Outcome: Family members' depressive symptoms
Measured: Three months following patient death or discharge from the ICU.
Patient Outcome: Patient centeredness of care
Measured: Three months following patient death or discharge from the ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician-Family Communication in Intensive Care UnitsStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Douglas B. White, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107704
- Sponsor's protocol ID
- K23AG032875
- Other IDs
- K23AG032875
- Status last verified
- Jan 2014
- First submitted
- 19 Apr 2010
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT01107704
- Acronym / sponsor ID
- K23AG032875
- Conditions
- Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients
- Keywords
- Intensive Care Units, Surrogates, Family Members, Physicians, Critically Ill, Depression, Anxiety, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Apr 2010 (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 on 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 to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.
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: Family Support Intervention |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must be unable to make treatment decisions for him/herself, as determined by the patient's physicians.
- must have have either an APACHE II score of ≥ 25 or, for patients with a primary neurologic diagnosis (e.g. intracranial hemorrhage, subdural hemorrhage, or subarachnoid hemorrhage), physician estimate that the patient has at least a 50% risk of long term, severe functional impairment
- must be 50 years old or greater.
Key exclusion criteria (2 listed)
- Patients who do not have surrogates or at least one family member who is willing to participate in the study.
- Patients awaiting organ transplantation.
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 |
|---|---|---|
| Family Support InterventionMultifaceted family support intervention | Behavioural | Family Support Intervention |
Primary outcome
Family Outcome: Family members' depressive symptoms
Time frame: Three months following patient death or discharge from the ICU.
Patient Outcome: Patient centeredness of care
Time frame: Three months following patient death or discharge from the ICU.
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 27 Jan 2014.
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.
Douglas B. White, MD, MAS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Support Intervention in people with Physician-Family Communication in Intensive Care Units and Surrogate Decision-making for Critically Ill Patients, 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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 27 Jan 2014. 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?
Family Outcome: Family members' depressive symptoms (time frame: Three months following patient death or discharge from the ICU.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2014.