Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Prolonged Mechanical Ventilation Clinical Trial

Official title:

Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751061
• Other study ID #: Pro00021965
• Secondary ID: R01HL109823-01A1
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 6, 2017

Study information

• Verified date: April 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: January 6, 2017
• Est. primary completion date: May 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Mechanical Ventilation
• Surrogate Decision Makers

Intervention

Behavioral:
• Decision aid
A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions

Other:
• Usual care
usual ICU care

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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