Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing

Abstract

Objective: To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.

Methods: We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.

Results: The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as "good" or "excellent"). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.

Conclusions: Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.

© 2020 American Academy of Neurology.

Figures

Figure 1. Stepwise decision aid (DA) development

We developed the DA for surrogate decision-makers of critically ill patients with traumatic brain injury (ciTBI) in 4 stages, with stakeholders included in the first 3 stages. Development stages 2 and 3 were used for iterative revisions after receiving feedback. A professional medical editor assessed the DA for language to ensure a 6th-grade reading level. Validated scales were used to assess acceptability and usability in stage 3. An open-label randomized controlled feasibility trial is ongoing. The timeline is shown to the right of the development stages. ICU = intensive care unit; TBI = traumatic brain injury.

Figure 2. Example of an individualized icon array used in our decision aid

Shown is the icon array for a 57-year-old patient with traumatic brain injury with motor Glasgow Coma Scale score 2, bilaterally reactive pupils, Marshall head CT classification II, absence of both preadmission hypoxia and preadmission hypotension, presence of traumatic subarachnoid hemorrhage, and absence of epidural hematoma on head CT. The mortality and unfavorable outcome probabilities are derived using the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) model with the publicly available IMPACT model prognostic calculator and converted into an icon array using the publicly available icon array creator. This was color-printed with a standardized legend and placed in an empty placeholder box in the preprinted decision aid spiral-bound booklet. In the decision aid, the icon array is described as only a “rough estimate of the outlook,” and includes a disclaimer about uncertainty, that the IMPACT model does not include all individual variables that may influence a patient's outcome, and to ask the physician in the family meeting about more details on the potential outcome of the specific patient.

Figure 3. Usability and acceptability results from the field testing (development stage 3)

Shown are the acceptability field-testing results from 18 surrogates recruited from the University of Massachusetts Medical School and Yale neurologic intensive care unit waiting rooms. We applied the acceptability scale, adapted from the original version. The multicolor scale graph represents the composite results of 9 questions asking users to grade how the information was presented in the decision aid as “excellent,” “good,” “fair,” or “poor.” A total of 97% rated the content as excellent or good. The light blue bar graphs show the proportion of favorable responses to 7 specific questions regarding our decision aid. Favorable was defined as “yes” on decision aid usefulness for making goals-of-care decisions; “balanced” for the presentation of the decision options; “easier” on how the tester thought the personal worksheet helped with making the decision; “yes” on enough information for surrogates to decide on goals of care; “just right” for the length of the decision aid and amount of information; and “easy to understand the different potential outcomes” on the way prognosis was explained. A total of 73% found the length of the decision aid “just right”; 27% found it “too long” and none “too short.” The amount of information was judged to be “just right” by 73%, “too little” by 7%, and “too much” by 20%.

Figure 4. Flowchart for feasibility trial

Shown is the number of screened, excluded, and included participants in the feasibility trial. The consent rate was 73% (16/22). Of the 16 participants included and randomized, 8 were randomized to decision aid or usual care. GOC = goals of care; PEG = percutaneous endoscopic gastrostomy; TBI = traumatic brain injury.