Improving Decision Making for Patients With Prolonged Mechanical Ventilation

NCT ID: NCT01751061

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-01-06

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.

Conditions

Surrogate Decision Makers; Prolonged Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decision aid

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

Group Type: EXPERIMENTAL

Decision aid

Intervention Type: BEHAVIORAL

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

Usual care

usual care in an intensive care unit setting

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

usual ICU care

Interventions

Decision aid

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

Intervention Type: BEHAVIORAL

Usual care

usual ICU care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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

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

Exclusion Criteria

• 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.

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher E Cox, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22635048 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30690645 (View on PubMed)

Other Identifiers

R01HL109823-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00021965

Identifier Type: -

Identifier Source: org_study_id