Evidence map›Paper›PMID 33203462›Full record

ArticleTrials2020

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

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Annemarie P M StiekemaDepartment of Psychiatry and Neuropsychology, School of Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.ORCID http://orcid.org/0000-0002-6739-3772
Christine ReschLimburg Brain Injury Center, Maastricht University, Maastricht, The Netherlands.
Mireille DonkervoortHealth Care and Social Work Division, Windesheim University of Applied Sciences, Almere, The Netherlands.
Natska JansenMevrouw Slimmer Werken Social Innovation in Health Care and Well-Being, Drogteropslagen, Netherlands.
Kitty H M JurriusHealth Care and Social Work Division, Windesheim University of Applied Sciences, Almere, The Netherlands.
Judith M ZadoksIn-Tussen Foundation, Utrecht, the Netherlands.
Caroline M van HeugtenDepartment of Psychiatry and Neuropsychology, School of Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands. c.vanheugten@maastrichtuniversity.nl.
Maastricht University · NLWindesheim University of Applied Sciences · NLBrain Injury Association of America · US

Funding

Ministerie van Volksgezondheid, Welzijn en Sport 328561
6 · The paper itself

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 18-24 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 registrationNetherlands Trial Register NL8104 . Registered on 22 October 2019.

Indexed as

Brain InjuriesCase ManagementAdultCaregiversEquivalence Trials as TopicHumansNetherlandsPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicBrain injuryCaregiversCase managementEarly interventionFamilyPsychosocialRandomized controlled trialStrokeTransitional careTraumatic brain injury

Identifiers

PMID33203462
PMCPMC7672813
OpenAlexW3101063862

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.