TY - JOUR
T1 - Case management after acquired brain injury compared to care as usual
T2 - study protocol for a 2-year pragmatic randomized controlled superiority trial with two parallel groups
AU - Stiekema, Annemarie P. M.
AU - Resch, Christine
AU - Donkervoort, Mireille
AU - Jansen, Natska
AU - Jurrius, Kitty H. M.
AU - Zadoks, Judith M.
AU - van Heugten, Caroline M.
N1 - Funding Information:
This study is supported by a grant from the Dutch Ministry of Health, Welfare and Sport to Stichting InTussen. Both the funder and the sponsor (Maastricht University) had no role in the study design and will have no role in the collection, management, analysis and interpretation of data nor in the decision to submit the report for publication.
Funding Information:
APMS and CMvH developed the study protocol. CR, MD, NJ, KHMJ and JMZ contributed to the study design and procedures. APMS wrote the first draft of this manuscript. All authors have read and approved the final version of this manuscript. The authors declare that they have no competing interests. This study is supported by a grant from the Dutch Ministry of Health, Welfare and Sport to Stichting InTussen. Both the funder and the sponsor (Maastricht University) had no role in the study design and will have no role in the collection, management, analysis and interpretation of data nor in the decision to submit the report for publication. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request after publication of the results. The Medical Ethics Committee of Maastricht University Medical Center+ approved the trial (registration number METC19-040). The study will be conducted according to the principles of the Declaration of Helsinki (World Medical Association, October 2013) and in accordance with the Dutch Medical Research Involving Human Subjects Act (Dutch: WMO). All people with ABI and family members will provide informed consent prior to participation.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12/17
Y1 - 2020/12/17
N2 - 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.
AB - 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.
KW - Brain injury
KW - Stroke
KW - Traumatic brain injury
KW - Caregivers
KW - Case management
KW - Transitional care
KW - Psychosocial
KW - Early intervention
KW - Family
KW - Randomized controlled trial
KW - LIFE SATISFACTION QUESTIONNAIRE
KW - TERM UNMET NEEDS
KW - QUALITY-OF-LIFE
KW - FOLLOW-UP
KW - DEPRESSION SCALE
KW - HOSPITAL ANXIETY
KW - SELF-MANAGEMENT
KW - STROKE
KW - VALIDITY
KW - RELIABILITY
U2 - 10.1186/s13063-020-04804-2
DO - 10.1186/s13063-020-04804-2
M3 - Article
C2 - 33203462
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 928
ER -