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

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ClinicalTrials.gov Identifier: NCT01982877
Recruitment Status : Recruiting
First Posted : November 13, 2013
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Douglas White, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Critically Ill Intensive Care Unit Patients Physician-Family Communication in Intensive Care Units Surrogate Decision-making for Critically Ill Patients Behavioral: Four Supports Intervention Behavioral: Educational Control Intervention Not Applicable

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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Family Support Intervention
Multifaceted family support intervention as well as ICU educational component.
Behavioral: Four Supports Intervention
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.
Behavioral: Educational Control Intervention
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.
Experimental: Educational Control
ICU educational component
Behavioral: Educational Control Intervention
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Patient and family-centeredness of care [ Time Frame: At 6 months ]
    Patient and family-centeredness of care measured using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted to use by surrogates.

  2. Total Hospital Costs [ Time Frame: Duration of hospital stay, an expected average of 4 weeks ]
    he costs are measured using aggregate data form the date of hospital admission through hospital discharge

  3. Intensive Care Unit Length of Stay [ Time Frame: Participants will be followed for duration of ICU stay, an expected average of 21 days ]
    The Intensive Care Unit length of stay , assessed by abstraction from hospital administrative records

  4. Hospital Length of stay [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks ]
    Hospital length of stay length of stay , assessed by abstraction from hospital administrative records

  5. Impact of Events scale at 6 months [ Time Frame: at 6 months ]
    Symptoms of post traumatic stress in family members assessed using the validated 22 item Impact of Events Scale.


Other Outcome Measures:
  1. Concordance between clinicians and surrogates about patient's prognosis (CSCS) [ Time Frame: 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 ]
    Prognostic estimates of survival and long-term functional impairment are measured responses by assessing the surrogate decision maker and the physician

  2. Decisional Conflict Scale (DCS) [ Time Frame: Participants are followed at time of enrollment and on day 5 of enrollment ]

    This validated instrument measures personal perceptions of:

    1. uncertainty in choosing options;
    2. modifiable factors contributing to uncertainty such as feeling uniformed, unclear about personal values and unsupported in decision making; and
    3. effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

  3. Quality of Communication Scale [ Time Frame: Day 5 of enrollment ]
    Quality of communication in family members is assessed using the validated 19 item Quality of Communication Scale

  4. Impact of Events Scale [ Time Frame: at 3 months ]
    Symptoms of post traumatic stress in family members assessed using the validated 22 item Impact of Events Scale.

  5. Inventory of Complicated Grief [ Time Frame: At 3 months and at 6 months ]
    This validated instrument consists of 19 first-person statements concerning the immediate bereavement-related thoughts and behaviors of the participant.

  6. Utilization of Mental Health Treatment [ Time Frame: At 3 months and 6 months ]
    The utilization of mental health treatment is tracked via participant interview

  7. Activity of Daily Living [ Time Frame: At 6 months ]
    Functional status of the patient is assessed using the validated Katz Activities of Daily Living Scale.

  8. Vital Status [ Time Frame: At 6 months ]
    Mortality of the patient will be assessed at 6 months using hospital administrative records, and the 6-month follow-up with surrogate decision makers.

  9. Discharge Dispensation [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks ]
    The disposition of the patient at time of discharge will be assessed via chart abstraction

  10. HADS [ Time Frame: at 3 months ]
    Hospital Anxiety and Depression Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 22 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 40% risk of long term severe functional impairment or 40% risk of in-hospital mortality
  • must be 21 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982877


Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15216
Contact: Douglas B White, MD, MAS    412-864-3757    whitedb@upmc.edu   
Contact: Anne-Marie Shields, RN, BSN, MSN    412-647-9102    shieldsa@upmc.edu   
Principal Investigator: Douglas B White, MD, MAS         
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)

Responsible Party: Douglas White, MD, MAS Vice Chair and Professor of Critical Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01982877     History of Changes
Other Study ID Numbers: 1R01AG045176-01 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Keywords provided by Douglas White, University of Pittsburgh:
decision making
values elicitation
patient centered care
Four Supports
Family Support

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes