Improving Decision Making for Patients With Prolonged Mechanical Ventilation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
University of Pittsburgh
University of Washington
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01751061
First received: December 13, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Surrogate Decision Makers
Prolonged Mechanical Ventilation
Behavioral: Decision aid
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinician-surrogate concordance scale score [ Time Frame: ~2-7 days post-randomization ] [ Designated as safety issue: No ]
    Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician, and, therefore, can range from 0 to 100.


Secondary Outcome Measures:
  • Hospital anxiety and depression scale (HADS) score [ Time Frame: Pre-randomization (study day 1) and post-randomization days ~2-7, 90, 180 ] [ Designated as safety issue: No ]
  • post-traumatic stress syndrome inventory [ Time Frame: Pre-randomization (study day 1) and post-randomization days ~2-7, 90, 180 ] [ Designated as safety issue: No ]
  • total health care costs [ Time Frame: over duration of study period (180 days) ] [ Designated as safety issue: No ]
  • patient-centeredness of care scale [ Time Frame: ~2-7, 90, and 180 days post-randomization ] [ Designated as safety issue: Yes ]
  • Medical comprehension scale score [ Time Frame: Study day 1 (pre-randomization), ~2-7 ] [ Designated as safety issue: No ]
  • Quality of communication scale score [ Time Frame: Study day 1 (pre-randomization), ~2-7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 410
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751061

Contacts
Contact: Derek M Jones, MDiv 919-681-6833 derek.m.jones@duke.edu
Contact: Derek M Jones, MDiv 919-613-6833 derek.m.jones@duke.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Shannon S Carson, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Christopher E Cox, MD MPH         
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Principal Investigator: Douglas B White, MD MS         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Catherine L Hough, MD MSc         
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
University of Pittsburgh
University of Washington
Investigators
Principal Investigator: Christopher E Cox, MD MPH Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01751061     History of Changes
Other Study ID Numbers: Pro00021965, R01HL109823-01A1
Study First Received: December 13, 2012
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
prolonged mechanical ventilation
chronic critical illness
decision making
decision aid
decisional support
critical illness
intensive care unit

ClinicalTrials.gov processed this record on August 01, 2014