A Communication Tool to Assist Severely Injured Older Adults

NCT03188055 | Completed Results DMC

• 2 other identifiers: 2016-1588R21AG055876-01
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on the quality of communication with older patients admitted to two trauma units. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and we are now testing whether the intervention will work in a different setting. We will test the intervention with severely injured older adults at Oregon Health Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of Texas Southwestern (UTS). In the first year, UTS/PMH and OHSU will recruit and enroll 50 patients in the control arm (total, for both sites) and train trauma surgeons to use the best case/worst case tool. In the second year, UTS/PMH and OHSU will recruit and enroll 50 patients in the intervention arm (total, for both sites). UW will compare survey-reported and chart-derived measures before and after clinicians learn to use the best case/worst case tool.

Conditions

Communication

Keywords

patient decision making; surgical decision making; shared decision making; decision support techniques

Outcome Measures

Primary Outcomes (2)

• Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon

  Family member-reported quality of end of life communication will be measured by the 7-item end of life subscale of the Quality of Communication scale. The QOC is a validated self-report instrument. The average score is given with a possible range of 0-10. Higher scores indicate higher perceived quality of end of life communication

  72 hours after trauma unit admission

• Family Member-reported General Communication (QOC) Received From Study Surgeon

  Family member-reported general quality of end communication will be measured by the 6-item general communication subscale of the Quality of Communication scale. The QOC is a validated self-report instrument. The average score is given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication

  72 hours after trauma unit admission

Secondary Outcomes (9)

• Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon

  72 hours after trauma unit admission

• Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon

  72 hours after trauma unit admission

• Family-reported Communication and Care Coordination

  10 days after trauma unit admission

• Family-reported Goal Concordant Care

  10 days after trauma unit admission

• Patient-reported Trauma Quality of Life (TQoL)

  30 days after trauma unit admission

Study Arms (2)

Best Case/Worst Case communication tool

EXPERIMENTAL

The patient's enrolled surgeon will have completed training on the Best Case/Worst Case communication tool and will be encouraged to use it with the patient.

Other: Best Case/Worst Case communication tool

Usual Care

NO INTERVENTION

Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention.Usual care also consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.

Interventions

Best Case/Worst Case communication tool OTHER

The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes. The surgeon verbally describes the "best case," "worst case," and "most likely" outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.

Best Case/Worst Case communication tool

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatically injured patients 50 and older admitted to the ICU

You may not qualify if:

• Surgeons will have an opportunity to exclude a patient or family who, in the physician's judgment, would not be an appropriate participant
• Patients with a Physician Orders for Life-Sustaining Medical Treatment (POLST) or Medical Orders for Life-Sustaining Medical Treatment (MOLST) form on file in their medical record that specifies that the patient or their decision maker wishes them to receive no intervention
• Patients with an isolated head injury as defined by a Head Abbreviated Injury Scale (AIS) score of 2 or less and an External AIS score of 1 or 0 and a Glasgow Coma Scale (GCS) score of 15. This serves to exclude the mildly traumatically brain injured patients with minimal external injuries who require ICU-level monitoring for a short period of time only
• Family Members
• N/A
• We will exclude patients whose family members do not speak English
• Under the age of 18
• Lack decision making capacity (DMC)
• Have a severe hearing or vision impairment.
• Surgeons
• N/A
• Care providers who do not directly provide primary trauma care in the ICU
• Residents who have not had at least 5 years of postgraduate training
• Trauma consultants including for example, neurosurgeons, orthopedic surgeons, and otolaryngologists
• Nurses

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator
• Oregon Health and Science University: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (2)

Oregon Health Sciences University

Portland, Oregon, 97239-3098, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Zimmermann CJ, Zelenski AB, Buffington A, Baggett ND, Tucholka JL, Weis HB, Marka N, Schoultz T, Kalbfell E, Campbell TC, Lin V, Lape D, Brasel KJ, Phelan HA, Schwarze ML. Best case/worst case for the trauma ICU: Development and pilot testing of a communication tool for older adults with traumatic injury. J Trauma Acute Care Surg. 2021 Sep 1;91(3):542-551. doi: 10.1097/TA.0000000000003281.

  PMID: 34039930 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Chart-derived treatment intensity as measured by the Simplified Therapeutic Intervention Scoring System (TISS-28) was removed as an outcome measure as this data was collected inconsistently, considered unreliable and therefore not analyzed.

Results Point of Contact

• Title: Margaret Lee Schwarze, MD, MPP, FACS
• Organization: University of Wisconsin, Madison

schwarze@surgery.wisc.edu

(608) 265-2358

Study Officials

• Gretchen Schwarze, MD, MPP, FACS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Karen Brasel, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Thomas Shoultz, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: July 14, 2017
• Primary Completion: December 20, 2019
• Study Completion: March 3, 2020
• Last Updated: November 4, 2025
• Results First Posted: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)