Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)

Prolonged Mechanical Ventilation Clinical Trial

Official title:

Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230099
• Other study ID #: 08-0601 0001 01 ME
• Secondary ID: R01NR012413-01A1
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: October 28, 2015
• Start date: October 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Critical Illness
• Critical Illness
• Prolonged Mechanical Ventilation

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Duke University School of Medicine	Durham	North Carolina
United States	Durham Regional Medical Center	Durham	North Carolina
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Duke University, National Institute of Nursing Research (NINR), University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale		Day 90	No
Secondary	Hospital Anxiety and Depression Scale		Day 18-20	No
Secondary	Impact of Events Scale-Revised		Day 90	No
Secondary	Discussion of Preferences for Patients Goals of Care	Subscale of Center for Gerontology and Health Care Research Toolkit	Day 18-20	No
Secondary	Quality of Communication	Curtis Measure	Day 18-20	No
Secondary	Family Satisfaction in the Intensive Care Unit (ICU) Survey		Day 90	No
Secondary	Modified Center for Gerontology and Health Care Research (CHCR) Tool		Day 90	No
Secondary	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	No
Secondary	Hospital Length of Stay	Days since randomization	Average of 60 days	No
Secondary	Mortality		Day 90	Yes
Secondary	Physician-Surrogate Discordance Score		day 18-20	No
Secondary	Discussion of Preferences for Patients Goals of Care	Subscale of Center for Gerontology and Health Care Research Toolkit	Day 90	No