CONNECT: A pragmatic clinical trial testing a remotely provided linkage to service coordination after hospitalization for TBI

Objective: To test whether a complex behavioral intervention delivered remotely to connect individuals to clinical resources after hospitalization for TBI improved their quality of life. Design/Methods: Community-based randomized pragmatic clinical trial. Main measures TBI-QOL, Activity Measure for Post-Acute Care (AM-PAC), Clinical Satisfaction and Competency Rating Scale. Results: 332 individuals ≥18 years-old hospitalized for TBI in four upper Midwest states were randomized to Remote (n = 166) and Usual Care (n = 166) groups. The groups were equivalent and representative of their state population’s racial and ethnic composition, age, and proportion living in rural communities. There were no significant differences within or between experimental groups over the study period in TBI-QOL t-scores. There was a significant improvement in AM-PAC Daily Activities within the Remote group and a significant between-group improvement in clinical satisfaction for the Remote group. Conclusion: Enrolling a representative, regional community-based sample of individuals with TBI can be successful, and delivering a customized complex behavioral intervention remotely is feasible. The overall lack of intervention effectiveness was likely due to enrolling individuals without pre-identified clinical needs, initiating intervention after the immediate post-acute phase when needs are often highest, inability to provide direct clinical care remotely, and potential lack of outcome measure responsiveness in our sample.