OBJECTIVE: To measure the effectiveness of a scheduled telephone intervention offering counseling and education to people with traumatic brain injury (TBI) on behavioral outcomes compared with standard follow-up at 1 year postinjury. DESIGN: Two-group randomized, prospective clinical trial throughout the first year after injury. SETTING:Subjects' homes via telephone in an urban-rural catchment area from a level I trauma center. PARTICIPANTS: Subjects (N=171; age range, 18-70 y) with a primary diagnosis of TBI who were discharged from an acute rehabilitation unit. They were randomly assigned to the telephone intervention (n=85) or to standard follow-up (n=86) groups at discharge. Of these, 79 participated in the intervention and completed the outcome assessment (3 withdrew; 3 were lost to follow-up), and 78 participated in usual care and completed the outcome assessment (8 were lost to follow-up). INTERVENTIONS: Subjects were randomly assigned to receive telephone calls at 2 and 4 weeks and 2, 3, 5, 7, and 9 months after discharge. The calls consisted of brief motivational interviewing, counseling, and education, plus facilitating usual care or usual care alone through follow-up appointments and therapy prescriptions. MAIN OUTCOME MEASURES: A composite outcome was used as the primary endpoint on an intent-to-treat basis. Secondary analyses were conducted with individual measures, including the FIM instrument, Disability Rating Scale, Community Integration Questionnaire, Neurobehavioral Functioning Inventory, Functional Status Examination, Glasgow Outcome Scale-Extended, Medical Outcomes Study 36-Item Short-Form Health Survey, Brief Symptom Inventory, EuroQol, and Modified Perceived Quality of Life scale. The primary analysis was a blocked Mann-Whitney U test. RESULTS: At 1-year follow-up, those who had received scheduled telephone intervention fared significantly better on the primary composite outcome index ( P =.002). In addition, this group fared better on specific composites such as functional status ( P =.003) and quality of well-being ( P =.006). There were no significant differences on vocational status ( P =.08) or community integration status ( P =.13). CONCLUSIONS: Scheduled telephone counseling and education resulted in improved overall outcome, particularly for functional status and quality of well-being, when compared with usual outpatient care. Telephone counseling shows promise as a low-cost, widely available rehabilitation intervention for TBI.
RCT Entities:
OBJECTIVE: To measure the effectiveness of a scheduled telephone intervention offering counseling and education to people with traumatic brain injury (TBI) on behavioral outcomes compared with standard follow-up at 1 year postinjury. DESIGN: Two-group randomized, prospective clinical trial throughout the first year after injury. SETTING: Subjects' homes via telephone in an urban-rural catchment area from a level I trauma center. PARTICIPANTS: Subjects (N=171; age range, 18-70 y) with a primary diagnosis of TBI who were discharged from an acute rehabilitation unit. They were randomly assigned to the telephone intervention (n=85) or to standard follow-up (n=86) groups at discharge. Of these, 79 participated in the intervention and completed the outcome assessment (3 withdrew; 3 were lost to follow-up), and 78 participated in usual care and completed the outcome assessment (8 were lost to follow-up). INTERVENTIONS: Subjects were randomly assigned to receive telephone calls at 2 and 4 weeks and 2, 3, 5, 7, and 9 months after discharge. The calls consisted of brief motivational interviewing, counseling, and education, plus facilitating usual care or usual care alone through follow-up appointments and therapy prescriptions. MAIN OUTCOME MEASURES: A composite outcome was used as the primary endpoint on an intent-to-treat basis. Secondary analyses were conducted with individual measures, including the FIM instrument, Disability Rating Scale, Community Integration Questionnaire, Neurobehavioral Functioning Inventory, Functional Status Examination, Glasgow Outcome Scale-Extended, Medical Outcomes Study 36-Item Short-Form Health Survey, Brief Symptom Inventory, EuroQol, and Modified Perceived Quality of Life scale. The primary analysis was a blocked Mann-Whitney U test. RESULTS: At 1-year follow-up, those who had received scheduled telephone intervention fared significantly better on the primary composite outcome index ( P =.002). In addition, this group fared better on specific composites such as functional status ( P =.003) and quality of well-being ( P =.006). There were no significant differences on vocational status ( P =.08) or community integration status ( P =.13). CONCLUSIONS: Scheduled telephone counseling and education resulted in improved overall outcome, particularly for functional status and quality of well-being, when compared with usual outpatient care. Telephone counseling shows promise as a low-cost, widely available rehabilitation intervention for TBI.
Authors: Megan E Shepherd-Banigan; Abigail Shapiro; Jennifer R McDuffie; Mira Brancu; Nina R Sperber; Courtney H Van Houtven; Andrzej S Kosinski; Neha N Mehta; Avishek Nagi; John W Williams Journal: J Gen Intern Med Date: 2018-05-07 Impact factor: 5.128
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