Comparing Two Models of Transition from Inpatient Rehabilitation Following Traumatic Brain Injury: A Pragmatic Comparative Effectiveness Trial.

Moderate to severe traumatic brain injury (msTBI) results in physical, cognitive, behavioral, and psychosocial difficulties. Those who receive inpatient rehabilitation following a msTBI need assistance after discharge. Patients and their families often struggle to find information, manage symptoms, and identify and access relevant services. Inadequate transition services from hospital-based care to the community can perpetuate and amplify the consequences of msTBI. There is a critical need for enhanced transitional care following hospital discharge. The goal of the current study was to compare two existing models for supporting the transition in the United States: 1. The Commission on Accreditation of Rehabilitation Facilities (CARF) model focused on transition planning prior to discharge (denominated Rehabilitation Discharge Plan [RDP]) and 2. The Veterans Health Administration model which provides a more intensive approach, extending beyond discharge, to enhance transitional care services (denominated Rehabilitation Transition Plan [RTP]). A six-center, 1:1 randomized pragmatic clinical trial with masked outcome assessment was conducted to compare the effectiveness of these two approaches. All participants received the RDP, including: 1. Patient and family education; 2. Written discharge instructions reviewed with the patient and family prior to discharge; and 3. A brief phone call from an inpatient care provider post discharge to identify any immediate problems. Those randomized to the RTP intervention also received up to 12 scheduled contacts during the 6 months following discharge from a trained care manager to assess needs, provide education, and resource facilitation. The primary outcomes were societal participation (participation assessment with recombined tools-objective) and quality of life (quality of life after brain injury scale) at 6 months post discharge. We hypothesized that patients randomized to RTP would report better participation and health-related quality of life (HRQoL) at the end of intervention and at 1-year post discharge compared with patients randomized to RDP. Second, we hypothesized that patients randomized to RTP would experience a steeper trajectory of improvement in participation and HRQoL over 12 months compared to patients randomized to RDP. A total of 925 patients were randomized. The results showed no significant differences between the two interventions on societal participation or HRQoL. Likewise, analysis of trajectory of outcomes did not show treatment group differences, and most patient participants had minimal change across all time points. Preinjury limitations, Medicaid insurance, and lower function contributed to worse outcomes but there was evidence for an interaction with the intervention for clinical sites and whether participants had an enrolled caregiver, which differed by group (increased participation with no enrolled caregiver in RTP, and better HRQoL with a caregiver for RDP). A key limitation of the study was the length of the intervention, with our patient, family, and professional partners reporting that 6 months might be insufficient to address the many needs that arise after msTBI.