Advancing Discussions Using a Video-based Support Tool About End-of-life Care (ADVISE)

Advancing Discussions Using a Video-based Support Tool About End-of-life Care: the ADVISE Project

The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults

Study Overview

• Status: Recruiting
• Conditions: Traumatic Injury
• Intervention / Treatment: Behavioral: Video conversation aid; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thaddeus J Puzio, MD, MS, FACS; Phone Number: 713-500-7218; Email: Thaddeus.J.Puzio@uth.tmc.edu
• Study Contact Backup: Name: Erin Fox; Phone Number: (713) 500-7965; Email: Erin.E.Fox@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Thaddeus J Puzio, MD, MS, FACS; Phone Number: 713-500-7218; Email: Thaddeus.J.Puzio@uth.tmc.edu
      • Contact: Erin Fox; Phone Number: (713) 500-7965; Email: Erin.E.Fox@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English or Spanish speaking
• admitted to any level of care following trauma

Exclusion Criteria:

• Prisoners
• Existing do not resuscitate (DNR)/do not intubate (DNI)
• Patients admitted while on hospice
• Patients not expected to survive over 24-48 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; Participants and/or surrogates will participate in discussions surrounding life-sustaining care at healthcare provider discretion.
Experimental: Video conversation aid	Behavioral: Video conversation aid; A video conversation aid which provides information regarding life-sustaining care and encourages further goals of care discussions with a healthcare provider will be shown to patients or their surrogates (for those incapacitated and unable to make their own decisions) on admission or within 48 hours whenever feasible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who had a transition in code status from full code	Data will be reported categorically as number of participants who transitioned from full code to DNR/DNI, DNR, ok for intubation, or Comfort measures only	at time of discharge (about 5 days after admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants that recognize survival after Cardiopulmonary resuscitation (CPR) as less than 50 percent as assessed by a survey		at time of discharge (about 5 days after admission)
Number of participants that received information about life-sustaining care outcomes as assessed by a survey		at time of discharge (about 5 days after admission)
Number of participants that desire more information regarding life-sustaining care as assessed by a survey		at time of discharge (about 5 days after admission)
Number of participants that had hospital-free days		in the first 30 days after admission
Number of participants that had ICU-free days		at time of discharge (about 5 days after admission)
Discharge disposition	Data will be reported categorically as number of participants that were discharged to home, nursing facility, rehab facility, long term care hospital, hospice or number of participants that die	at time of discharge (about 5 days after admission)
Number of participants that had ventilator-free days		at time of discharge (about 5 days after admission)
Decisional conflict score as assessed by the Decisional Conflict Scale	This is a 4 item questionnaire, each is scored as 0(no) or 1(yes), for a maximum score of 4, higher score indicating no decisional conflict	at time of discharge (about 5 days after admission)
Number of interventional procedures	Procedures include tracheostomy, feeding tube placement, dialysis initiation	at time of discharge (about 5 days after admission)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Thaddeus J Puzio, MD, MS, FACS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death
• Other Study ID Numbers: HSC-MS-24-1256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No