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

ABSTRACT

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.

KEYWORDS:

• Traumatic brain injury
• rehabilitation
• pragmatic clinical trial
• information communication technology

Acknowledgments

This research was supported by the National Institute on Disability, Independent Living, and Rehabilitation Research, under Grant 90DPTB0012, Traumatic Brain Injury Model Systems.

The authors would like to acknowledge Dr. Molly Sullan for her work in helping to create the CSCRS measure used in this study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website

Additional information

Funding

This work was supported by the National Institute on Disability, Independent Living, and Rehabilitation Research [90DPTB0012].