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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012413-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| University of North Carolina | OTHER |
| Duke University | OTHER |
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The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Information Team Group | Experimental | Protocolized information and support meetings led by palliative care clinicians |
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| Usual Care Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Information Team Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | Day 18-20 | |
| Impact of Events Scale-Revised | Day 90 | |
| Discussion of Preferences for Patients Goals of Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Nelson, MD, JD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Shannon Carson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| University of North Carolina School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28387538 | Derived | Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC. | |
| 27380343 | Derived | Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Subscale of Center for Gerontology and Health Care Research Toolkit |
| Day 18-20 |
| Quality of Communication | Curtis Measure | Day 18-20 |
| Family Satisfaction in the Intensive Care Unit (ICU) Survey | Day 90 |
| Modified Center for Gerontology and Health Care Research (CHCR) Tool | Day 90 |
| Limitation of Intensive Care Unit (ICU) Therapy | Percent of patients with mechanical ventilation, renal replacement, vasopressors, or artificial nutrition withheld or withdrawn | Average of 60 days |
| Hospital Length of Stay | Days since randomization | Average of 60 days |
| Mortality | Day 90 |
| Physician-Surrogate Discordance Score | day 18-20 |
| Discussion of Preferences for Patients Goals of Care | Subscale of Center for Gerontology and Health Care Research Toolkit | Day 90 |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Durham Regional Medical Center | Durham | North Carolina | 27704 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |