Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
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Purpose
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
| Condition | Intervention |
|---|---|
|
Chronic Critical Illness Prolonged Mechanical Ventilation |
Behavioral: Supportive Information Team Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT) |
- Hospital Anxiety and Depression Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]
- Impact of Events Scale-Revised [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Discussion of Preferences for Patients Goals of Care [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]Subscale of Center for Gerontology and Health Care Research Toolkit
- Quality of Communication [ Time Frame: Day 18-20 ] [ Designated as safety issue: No ]Curtis Measure
- Family Satisfaction in the Intensive Care Unit (ICU) Survey [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Modified Center for Gerontology and Health Care Research (CHCR) Tool [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Limitation of Intensive Care Unit (ICU) Therapy [ Time Frame: Average of 60 days ] [ Designated as safety issue: No ]Percent of patients with mechanical ventilation, renal replacement, vasopressors, or artificial nutrition withheld or withdrawn
- Hospital Length of Stay [ Time Frame: Average of 60 days ] [ Designated as safety issue: No ]Days since randomization
- Mortality [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
- Physician-Surrogate Discordance Score [ Time Frame: day 18-20 ] [ Designated as safety issue: No ]
- Discussion of Preferences for Patients Goals of Care [ Time Frame: Day 90 ] [ Designated as safety issue: No ]Subscale of Center for Gerontology and Health Care Research Toolkit
| Estimated Enrollment: | 620 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supportive Information Team Group
Protocolized information and support meetings led by palliative care clinicians
|
Behavioral: Supportive Information Team Group
A minimum of two protocolized, interdisciplinary, informational support meetings led by palliative care clinicians will be arranged with family members or other patient surrogates who participate in decision-making for individual chronically critically ill patients.
Other Name: SIT
|
| No Intervention: Usual Care Group |
Detailed Description:
Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering >100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients ≥ 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is a randomized, controlled, multi-center clinical trial of such an intervention. Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients; and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mechanically ventilated ≥ 7 days
- Mechanically ventilated without > 96 hour interruption
- Age ≥ 21 years
- ICU MD does not expect patient will die within 72 hours
- ICU MD does not expect patient will be liberated from the ventilator within 72 hours.
Exclusion Criteria:
- Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for > 7 days before transfer
- Chronic Neuromuscular (NM) Disease
- Trauma
- Burn
- Previous palliative care consultation in this hospitalization
- No family or other surrogate decision-maker
- Family not available
- Surrogate lacks English proficiency
- Physician refused permission for research staff to approach the family
Contacts and Locations| Contact: Stefanie Weiss | 212-241-7258 | stefanie.weiss@exchange.mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Stefanie Weiss 212-241-7258 stefanie.weiss@exchange.mssm.edu | |
| Principal Investigator: Judith Nelson, MD, JD | |
| United States, North Carolina | |
| University of North Carolina School of Medicine | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Joyce Lanier 919-966-2531 joyce_lanier@med.unc.edu | |
| Principal Investigator: Shannon Carson, MD | |
| Duke University School of Medicine | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Christopher Cox, MD 919-681-7232 christopher.cox@duke.edu | |
| Principal Investigator: Christopher Cox, MD | |
| Durham Regional Medical Center | Recruiting |
| Durham, North Carolina, United States, 27704 | |
| Contact: Christopher Cox, MD 919-681-7232 christopher.cox@duke.edu | |
| Principal Investigator: Christopher Cox, MD | |
| Principal Investigator: | Judith Nelson, MD, JD | Mount Sinai School of Medicine |
| Principal Investigator: | Shannon Carson, MD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01230099 History of Changes |
| Other Study ID Numbers: | 08-0601 0001 01 ME, R01NR012413-01A1 |
| Study First Received: | October 22, 2010 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Critical Illness Mechanical Ventilation Palliative Care Caregivers |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013