Collaborative Care versus Usual Care to Improve Quality of Life, Pain, Depression, and Physical Activity in Outpatients with Spinal Cord Injury: The SCI-CARE Randomized Controlled Clinical Trial

Our goal was to test the effectiveness of collaborative care (CC) versus usual care (UC) to improve treatment of pain, depression, physical inactivity, and quality of life in outpatients with spinal cord injury (SCI). We conducted a single blind parallel group randomized controlled trial. The setting was two outpatient SCI rehabilitation clinics within a large academic medical center. Participants were 174 outpatients who were on average 47.7 years old, 76% male, 76% white, 8% Hispanic, 47% tetraplegic, 95% more than 1 year post-SCI, and 45% on Medicare. The intervention consisted of a mental health-trained collaborative care manager (CM) integrated into two SCI rehabilitation medicine clinics and supervised by content experts in pain and mental health treatment. The CM provided assessment, medical care coordination, adherence support, outcome monitoring, and decision support along with brief psychological interventions to the patients via up to 12 in-person or telephone sessions. Among all participants, 61% chose to focus on pain; 31% on physical activity and 8% on depression. The primary outcome was quality of life as measured by the World Health Organization Quality of Life-BREF at the end of treatment (4 months). Secondary outcomes were quality of life at 8 months and pain intensity and interference, depression severity, and minutes per week of moderate to vigorous physical activity at 4 and 8 months. A total of 174 participants were randomized 1:1 to CC (n = 89) versus UC (n = 85). The primary analysis, a mixed-effects linear regression adjusting for time since injury and sex, revealed a non-significant trend for greater improvement in quality of life in CC versus UC at 4 months (p = 0.083). Secondary analyses showed that those receiving CC reported significantly greater improvement in pain interference at 4- and 8-months and in depression at 4-months, but no significant effect on physical activity. We conclude that in an outpatient SCI care setting, CC is a promising model for delivering integrated medical and psychological care and improving management of common, chronic, disabling conditions such and pain and depression.