Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial

Abstract

Objective: s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients.

Design: Randomized controlled trial.

Setting: Three tertiary care PICUs in the United States.

Patients: Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours.

Interventions: Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32).

Measurements and main results: Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes.

Conclusions: A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.

Trial registration: ClinicalTrials.gov NCT02209935.

Conflict of interest statement

Conflicts of Interest: This research was supported by Patient Centered Outcomes Research Institute (PCORI) (CER-1310–08343) (E.L.F.). The remaining authors report no conflicts.

Conflict of Interest Disclosures: This research was supported by Patient Centered Outcomes Research Institute (CER-1310–08343) (E.L.F.). The remaining authors report no conflicts.

Copyright form disclosure: Drs. Fink, Houtrow, Richichi, Ortiz-Aguayo, Smith, and Kochanek institution received funding from Patient Centered Outcomes Research Institute (PCORI). Dr.

Richichi disclosed that he does statistical analysis for the University of Pittsburgh, and disclosed work for hire. Dr. Kochanek received support for article research from PCORI. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Figures

Figure 1.

CONSORT diagram. PICU, pediatric intensive care unit; LOS, length of stay; PT, physical therapy; OT, occupational therapy; SLT, speech and language therapy; DNR, do not resuscitate