Improving Decision Making for Patients With Prolonged Mechanical Ventilation

NCT01751061 | Completed Results DMC

• 2 other identifiers: Pro00021965R01HL109823-01A1
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 4

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).

Conditions

Surrogate Decision Makers; Prolonged Mechanical Ventilation

Keywords

prolonged mechanical ventilation; chronic critical illness; decision making; decision aid; decisional support; critical illness; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS) Total Score

  Pre-randomization (study day 1) and 180 days post-randomization

• Post-traumatic Stress Syndrome Inventory

  Pre-randomization (study day 1) and 180 days post-randomization

• Patient-centeredness of Care Scale

  Study day 1 and 180 days post-randomization

• Medical Comprehension Scale Score

  Study day 1 (pre-randomization), ~2-7

• Quality of Communication Scale Score

  Study day 1 (pre-randomization), ~2-7

Study Arms (2)

Decision aid

EXPERIMENTAL

Web-based decision aid (decision support tool) provided to surrogate decision maker

Behavioral: Decision aid

Usual care

ACTIVE COMPARATOR

usual care in an intensive care unit setting

Other: Usual care

Interventions

Decision aid BEHAVIORAL

A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions

Decision aid

Usual care OTHER

usual ICU care

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• age ≥18
• self-identified as participating directly in health care decision making for the incapable patient under relevant state law
• 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)
• ICU attending or fellow (physicians) at the time of surrogate enrollment
• bedside ICU nurse present at the time of surrogate enrollment

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator
• University of Pittsburgh: collaborator
• University of Washington: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 22635048 BACKGROUND

• 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.

  PMID: 30690645 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Christopher Cox
• Organization: Duke University

Christopher.cox@duke.edu

9196817232

Study Officials

• Christopher E Cox, MD MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: January 1, 2013
• Primary Completion: May 3, 2016
• Study Completion: January 6, 2017
• Last Updated: May 2, 2019
• Results First Posted: May 2, 2019

Record last verified: 2019-04

Locations

US (4)