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

NCT06804226 | Recruiting

• 1 other identifier: HSC-MS-24-1256
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

Study Arms (2)

Video conversation aid

EXPERIMENTAL

Behavioral: Video conversation aid

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Video conversation aid BEHAVIORAL

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

Video conversation aid

Usual Care BEHAVIORAL

Participants and/or surrogates will participate in discussions surrounding life-sustaining care at healthcare provider discretion.

Usual Care

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Thaddeus J Puzio, MD, MS, FACS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaddeus J Puzio, MD, MS, FACS

CONTACT

713-500-7218; Thaddeus.J.Puzio@uth.tmc.edu

Erin Fox

CONTACT

(713) 500-7965; Erin.E.Fox@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)