Improving Decision Making for Patients With Prolonged Mechanical Ventilation

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).

Study Overview

• Status: Completed
• Conditions: Prolonged Mechanical Ventilation; Surrogate Decision Makers
• Intervention / Treatment: Behavioral: Decision aid; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (Patient characteristics required for surrogate inclusion)

• age ≥18
• ≥10 days of mechanical ventilation interrupted by <96 continuous hours of unassisted breathing (including invasive and non-invasive ventilation)
• no anticipation of imminent (24 hours) death or extubation by the attending.

Exclusion Criteria (Patient characteristics that will exclude surrogates from study enrollment):

• possession of decisional capacity
• no identifiable surrogate, surrogate is unavailable for study procedures such as interviews
• imminent organ transplantation
• chronic neuromuscular disease
• physician refuses permission to approach family and/or patient for consent
• admission for severe burns
• admission for high cervical spine injury
• ventilation for >21 days.

Inclusion criteria for surrogate decision makers:

• age ≥18
• self-identified as participating directly in health care decision making for the incapable patient under relevant state law

Exclusion criteria for surrogate decision makers:

• do not personally know the patient
• need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)
• history of clinically important neurological disorder (e.g., dementia)
• patient dies after meeting inclusion criteria but before surrogates provide consent

Physician and nurse inclusion criteria:

• ICU attending or fellow (physicians) at the time of surrogate enrollment
• bedside ICU nurse present at the time of surrogate enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision aid; Web-based decision aid (decision support tool) provided to surrogate decision maker	Behavioral: Decision aid; A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
Active Comparator: Usual care; usual care in an intensive care unit setting	Other: Usual care; usual ICU care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician-surrogate Concordance Scale Score	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.	~2-7 days post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS) Total Score	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.	Pre-randomization (study day 1) and 180 days post-randomization
Post-traumatic Stress Syndrome Inventory	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.	Pre-randomization (study day 1) and 180 days post-randomization
Patient-centeredness of Care Scale	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.	Study day 1 and 180 days post-randomization
Medical Comprehension Scale Score	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.	Study day 1 (pre-randomization), ~2-7
Quality of Communication Scale Score	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.	Study day 1 (pre-randomization), ~2-7
Change in Clinical-surrogate Concordance Scale Score (Nurse)	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.	~2-7 days post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; University of Washington; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Christopher E Cox, MD MPH, Duke University

Publications and helpful links

General Publications

• Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
• Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 3, 2016
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; decision making; critical illness; decision aid; prolonged mechanical ventilation; chronic critical illness; decisional support
• Other Study ID Numbers: Pro00021965; R01HL109823-01A1 (U.S. NIH Grant/Contract)