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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

622 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Critical Illness Prolonged Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Supportive Information Team Group

Protocolized information and support meetings led by palliative care clinicians

Group Type EXPERIMENTAL

Supportive Information Team Group

Intervention Type 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.

Usual Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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SIT

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No