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

Annemarie P. M. Stiekema, Christine Resch, Mireille Donkervoort, Natska Jansen, Kitty H. M. Jurrius, Judith M. Zadoks, Caroline M. van Heugten*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BackgroundPeople 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.MethodsThis 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 18-24months 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.DiscussionAt 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 registrationNetherlands Trial Register NL8104. Registered on 22 October 2019.

Original languageEnglish
Article number928
Number of pages16
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 17 Dec 2020

Keywords

  • Brain injury
  • Stroke
  • Traumatic brain injury
  • Caregivers
  • Case management
  • Transitional care
  • Psychosocial
  • Early intervention
  • Family
  • Randomized controlled trial
  • LIFE SATISFACTION QUESTIONNAIRE
  • TERM UNMET NEEDS
  • QUALITY-OF-LIFE
  • FOLLOW-UP
  • DEPRESSION SCALE
  • HOSPITAL ANXIETY
  • SELF-MANAGEMENT
  • STROKE
  • VALIDITY
  • RELIABILITY

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