Case management for people with acquired brain injury: feasibility and effectiveness of a two-year pragmatic randomized controlled trial.

BACKGROUND: Case management (CM) aims to facilitate access to and integration of health care and social services. We investigated the feasibility and effectiveness of CM. METHODS: Randomized controlled trial with 219 patients and 114 caregivers randomly allocated to CM (109/59) or care as usual (110/55). CM was based on early and continuous online monitoring of problems and needs. Outcomes were assessed every 6 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcome domains were participant restrictions, life satisfaction, self-efficacy, caregiver burden, and needs. Multilevel modeling was used. Feasibility aspects were protocol delivery, participants' and case managers' satisfaction, and factors affecting implementation. RESULTS: There were no significant differences between groups. Participation restrictions and unmet needs decreased in both groups within 6 months. Monitoring was successful in 38, and 10 participants asked the CM for support. CM consisted mostly of providing information. DISCUSSION: CM based on early and continuous online monitoring does not have benefit in identifying and addressing problems early after relatively mild injury. Unsuccessful monitoring may have hindered access to the case manager and prevented us from evaluating CM as a complex intervention. It remains a challenge to early identify those who could benefit from care coordination.

Case management after acquired brain injury compared to care as usual: study protocol for a 2-year pragmatic randomized controlled superiority trial with two parallel groups.

BACKGROUND: People with acquired brain injury may suffer from cognitive, emotional and behavioural changes in the long term. Continuity of care is often lacking, leading to a variety of unmet needs and hindering psychosocial functioning from the occurrence of brain injury up to years thereafter. Case management aims to prevent (escalation of) problems and to facilitate timely access to appropriate services. In other populations, case management has shown to improve psychosocial well-being. In this study, we aim to evaluate the feasibility of case management after acquired brain injury and its effectiveness and cost-effectiveness, compared to care as usual. METHODS: This is a pragmatic randomized controlled superiority trial with two parallel groups and repeated measures in adults with ABI and their family, taking place between November 2019 and December 2021 in three provinces in the Netherlands. Participants will be randomly allocated to either the case management group, receiving case management from hospital discharge up to 2 years thereafter, or the control group, receiving care as usual. Effectiveness will be evaluated every 6 months for 18-24 months by patient-reported psychosocial well-being (Hospital Anxiety and Depression Scale (HADS), Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) restriction subscale and the Life Satisfaction Questionnaire (LiSat)), self-management (Patient Activation Measure (PAM)) and care needs (Longer-term Unmet Needs after Stroke (LUNS)). Family outcomes include self-efficacy (Carer Self-Efficacy Scale (CSES)), caregiver burden (Caregiver Strain Index (CSI)), psychosocial well-being (LiSat, HADS), family needs (Family Needs Questionnaire (FNQ)). Feasibility will be evaluated using qualitative methods, assessing fidelity, dose delivered, dose received, reach, recruitment and context. Cost-effectiveness will be determined by the EQ-5D-3L and service use. DISCUSSION: At the moment, there is no integrated health care service for people with acquired brain injury and their family members in the long term. If case management is shown to be feasible and (cost)-effective, it could bridge the gap between patients' and families' needs and the available services. TRIAL REGISTRATION: Netherlands Trial Register NL8104 . Registered on 22 October 2019.