Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Not Applicable

Completed

• Conditions: Prolonged Mechanical Ventilation; Surrogate Decision Makers
• Interventions: Other: Usual care; Behavioral: Decision aid

• Registration Number: NCT01751061
• Lead Sponsor: Duke University

Brief Summary

Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).

Detailed Description

The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.

Study Timeline

• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-17
• Study Start: 2013-01
• Primary Completion: 2016-05-03
• Study Completion: 2017-01-06
• Results First Submitted: 2019-03-05
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Results First Posted: 2019-05-02
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	usual care in an intensive care unit setting
Decision aid	Decision aid	Web-based decision aid (decision support tool) provided to surrogate decision maker

Primary Outcome Measures

Name	Time	Method
Change in Clinician-surrogate Concordance Scale Score	~2-7 days post-randomization	Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100.; We report pre-intervention to post-intervention difference in the CSCS.; The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.

Secondary Outcome Measures

Name	Time	Method
Post-traumatic Stress Syndrome Inventory	Pre-randomization (study day 1) and 180 days post-randomization	Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers.; PTSS scores can range from 10-70, with greater scores=more distress.
Patient-centeredness of Care Scale	Study day 1 and 180 days post-randomization	Here we report change in patient-centeredness score between Study day 1 (Interview 1) and 180 days post-randomization (Interview 4) for primary (not secondary) surrogate decision makers.; Scores can range from 12-48 points, with higher scores=greater patient-centeredness.
Quality of Communication Scale Score	Study day 1 (pre-randomization), ~2-7	Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.; Scores range from 0-110, with higher scores=better quality of communication.
Medical Comprehension Scale Score	Study day 1 (pre-randomization), ~2-7	Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.; Scores can range from 0-8, with greater scores=better comprehension.
Hospital Anxiety and Depression Scale (HADS) Total Score	Pre-randomization (study day 1) and 180 days post-randomization	We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary).; HADS scores can range from 0 to 42 points; higher scores=more distress.
Change in Clinical-surrogate Concordance Scale Score (Nurse)	~2-7 days post-randomization	Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the primary surrogate decision maker and the IUC nurse, and, therefore, can range from 0 to 100.; We report pre-intervention to post-intervention difference in the CSCS.; The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of the nurse to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.

Trial Locations

Locations (4)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Washington; 🇺🇸 Seattle, Washington, United States