Family Support Intervention in Intensive Care Units (The Four Supports Study)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Physician-Family Communication in Intensive Care Units Surrogate Decision-making for Critically Ill Patients |
Behavioral: Family Support Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients. |
- Family Outcome: Family members' depressive symptoms [ Time Frame: Three months following patient death or discharge from the ICU. ] [ Designated as safety issue: No ]
- Patient Outcome: Patient centeredness of care [ Time Frame: Three months following patient death or discharge from the ICU. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 175 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Family Support Intervention |
Behavioral: Family Support Intervention
Multifaceted family support intervention
|
| No Intervention: Control Group |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for ICU Patients:
- 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.
Exclusion Criteria for ICU Patients:
- Patients who do not have surrogates or at least one family member who is willing to participate in the study.
- Patients awaiting organ transplantation.
Contacts and Locations| Contact: Anne-Marie Shields, MSN, RN | 412-647-9102 | shieldsa@upmc.edu |
| Contact: Nicole Caliari, RN | Caliarin@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center (UPMC) | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| Contact: Anne-Marie Shields, MSN, RN 412-647-9102 | |
| Contact: Nicole Caliari, BSN, RN caliarin@upmc.edu | |
| Principal Investigator: Douglas B. White, MD, MAS | |
| Principal Investigator: | Douglas B. White, MD, MAS | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01107704 History of Changes |
| Other Study ID Numbers: | K23AG032875, K23AG032875 |
| Study First Received: | April 19, 2010 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Intensive Care Units Surrogates Family Members Physicians Critically Ill Depression Anxiety |
Emotional Support Multi-faceted communication Grief Prognosis Family Support Counselor |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013