A Goal-Oriented Randomized Controlled Intervention in the Chronic Phase of Traumatic Brain Injury: Feasibility, Patient-Reported Problem Areas, and Goal Attainment

Abstract

A broad range of symptoms may be expected in patients experiencing a traumatic brain injury (TBI), and for some these difficulties persist for decades after their injury. Further, many individuals with TBI and their families report long-term unmet health care needs. The variability in expected symptoms post TBI is high, which necessitates an individualized approach in assessing and treating these patients. Further, to improve the patient-centeredness and personal relevance of rehabilitation approaches, treatment should be goal-oriented and conducted within the context of the patient’s everyday life. This thesis was written in the context of a randomized controlled trial (RCT) that aims to investigate the efficacy of a goal-oriented and home-based rehabilitation intervention for individuals in the chronic phase of TBI. The overall aim of the thesis is to cover knowledge gaps about treatment needs and options in the chronic phase of TBI by developing an individualized rehabilitation intervention with suitable goal attainment measures to be evaluated in an RCT. This thesis displays the feasibility testing (paper I), the study protocol (paper II), the utility of an individualized assessment approach (paper III), and the goal attainment in the intervention group (paper IV). The first aim was to investigate the feasibility of the intervention delivery. Paper I displayed that although the intervention was considered feasible and acceptability was high, some amendments was needed before establishing the final protocol for the RCT. As a result of the feasibility trial, eligibility criteria were amended, the baseline assessment was abbreviated, and the included outcome measures and their order were modified. Paper II displays the full study protocol for the RCT, including study design, setting, intervention content and planned analyses for the efficacy evaluation of this trial. In paper III, an individualized approach (Target Outcomes) to attain information about main patient-reported problems areas after TBI was evaluated and compared to standardized outcome measures. In total 120 individuals with persistent symptoms at least two years after a TBI was included. Target Outcomes were reported in the domains of cognitive, physical, emotional, and social functioning, and covered 24 distinct sub-categories. Further, comparison with standardized measures displayed that the Target Outcome approach provided a more detailed picture of the problem profile of each participant. It was concluded that this approach might be a useful addition to assessing idiosyncratic TBI-related difficulties that may aid clinicians and researchers in planning interventions for these patients. Paper IV displayed goal attainment results from the intervention group of the RCT. Goal attainment was high and all 59 patients displayed overall improved goal attainment at the final intervention session. Goal attainment did not vary depending on the type of goal, i.e., goals within different domains (cognitive, physical, emotional, social) were attainable at the same levels. Individuals who were less educated, experienced less cognitive and executive impairments, and had high outcome expectation at session 3 showed higher goal attainment at session 8. These findings should be considered preliminary, and more research on indicators of goal attainment is warranted. In summary, this thesis displays insights into the delivery of an individualized approach to rehabilitation in the chronic phase of TBI. It provides a transparent look into aspects of conducting a RCT such as feasibility testing and protocol establishment. It also expands current knowledge about individualized approaches that may aid in the planning and delivery of rehabilitation interventions for patients in the chronic phase of TBI, ensuring the delivery of an evidence-based and patient-centered intervention. Individualized and patientcentered approaches are considered crucial to improve outcomes in the chronic phase of TBI.

The efficacy evaluation of the RCT is pending the completion of final outcome assessments and results are expected to be available in 2022.