Pilot Trial of a Web/Mobile/Tablet-based Communication and Goals-of-Care Decision Aid for Clinicians and Families of Severe Acute Brain Injury Patients

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• surrogate is age 18 years or older, no upper age limit;

• documented surrogate decision-maker (official health care proxy, or legal next of kin) of a critically ill severe acute brain injury (SABI) patient ≥ 3 days after admission;

• patient is age 18 years or older, no upper age limit;

• patient has SABI; defined as either traumatic brain injury, spontaneous primary intracerebral hemorrhage (not due to tumor or vascular malformation), or hemispheric acute ischemic stroke;

• patient iscritically ill defined as either intubated on a mechanical ventilator, or unable to swallow without a feeding tube (even if not intubated/ventilated);

• patient is judged by the attending physician to have ≥40% risk of death or long-term functional impairment, elicited by asking the attending physician, does this patient have at least a 40% chance of in-hospital mortality or long-term functional impairment?, defined as needing assistance with at least 1 activity of daily living (ADL).

• patient has undergone initial stabilization but remains critically ill;

• surrogate will participate in clinician-family goals of care meeting, either in person or via video- or telephone-conference.

• surrogate must be English speaking and literate

• clinical treating attending, or physician trainee (fellow, resident), or licensed affiliated practitioner who will lead the clinician-family meeting when goals-of-care are discussed;

• clinician may decline participation in the outcome measures but cannot restrict the surrogate decision-maker in study participation.

Locations
United States
Massachusetts
UMass Memorial Hospital
RECRUITING
Worcester
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Susanne Muehlschlegel, MD, MPH
susanne.muehlschlegel@umassmed.edu
(617)866-8289
Backup
Susanne Muehlschlegel, MD, MPH
smuehlsch@jhu.edu
(410)502-6534
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 50
Treatments
Experimental: Web-based Decision Aid + Communication (DA+C) tool
Surrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet. Surrogate(s) will have unlimited access to the DA+C tool and may return to the tool and edit the worksheet at any time.
No_intervention: Usual Care
No decision aid
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR), Johns Hopkins University, National Institutes of Health (NIH), Worcester Polytechnic Institute
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov