Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Stroke | Study protocol

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

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

Published in: Trials | Issue 1/2020

Login to get access

Abstract

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.
Literature
1.
Allanson F, Pestell C, Gignac GE, Yeo YX, Weinborn M. Neuropsychological predictors of outcome following traumatic brain injury in adults: a meta-analysis. Neuropsychol Rev. 2017;27:187–201.PubMedCrossRef
2.
Jokinen H, Melkas S, Ylikoski R, Pohjasvaara T, Kaste M, Erkinjuntti T, et al. Post-stroke cognitive impairment is common even after successful clinical recovery. Eur J Neurol. 2015;22:1288–94.PubMedCrossRef
3.
De Wit L, Theuns P, Dejaeger E, Devos S, Gantenbein AR, Kerckhofs E, et al. Long-term impact of stroke on patients’ health-related quality of life. Disabil Rehabil. 2017;39:1435–40.PubMedCrossRef
4.
Bieńkiewicz MMN, Brandi ML, Hughes C, Voitl A, Hermsdörfer J. The complexity of the relationship between neuropsychological deficits and impairment in everyday tasks after stroke. Brain Behav. 2015;5:1–14.CrossRef
5.
Murray J, Young J, Forster A, Ashworth R. Developing a primary care-based stroke model: the prevalence of longer-term problems experienced by patients and carers. Br J Gen Pract. 2003;53:803–7.PubMedPubMedCentral
6.
Jennekens N, Dierckx de Casterlé B, Dobbels F. A systematic review of care needs of people with traumatic brain injury (TBI) on a cognitive, emotional and behavioural level. J Clin Nurs. 2010;19:1198–206.PubMedCrossRef
7.
Blake H. Caregiver stress in traumatic brain injury. Int J Ther Rehabil. 2014;15:263–71.CrossRef
8.
Anderson MI, Simpson GK, Morey PJ. The impact of neurobehavioral impairment on family functioning and the psychological well-being of male versus female caregivers of relatives with severe traumatic brain injury: multigroup analysis. J Head Trauma Rehabil. 2013;28:453–63.PubMedCrossRef
9.
Stokman M, Verhoeff H, Heineke D. Navigeren naar herstel; 2011.
10.
Stiekema APM, Winkens I, Ponds R, De Vugt ME, Van Heugten CM. Finding a new balance in life: a qualitative study on perceived long-term needs of people with acquired brain injury and partners. Brain Inj. 2020;00:1–9. Taylor & Francis.
11.
Pindus DM, Mullis R, Lim L, Wellwood I, Rundell AV, Aziz NAA, et al. Stroke survivors’ and informal caregivers’ experiences of primary care and community healthcare services – a systematic review and meta-ethnography. PLoS One. 2018;13:e0196185.PubMedPubMedCentralCrossRef
12.
Ontario Neurotrauma Foundation. Clinical practice guideline for the rehabilitation of adults with moderate to severe TBI [Internet]. 2016.
13.
Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47:e98–169.PubMedCrossRef
14.
Norrving B, Barrick J, Davalos A, Dichgans M, Cordonnier C, Guekht A, et al. Action plan for stroke in Europe 2018–2030. Eur Stroke J. 2018;3:309–36.PubMedPubMedCentralCrossRef
15.
Sacco RL, Sandercock P, Endres M, Feigin V, Pandian J, Shinohara Y, et al. Review and prioritization of stroke research recommendations to address the mission of the World Stroke Organization: a call to action from the WSO Research Committee. Int J Stroke. 2015;10:4–9.PubMedCrossRef
16.
Vroomen JMN, Bosmans JE, Eekhout I, Joling KJ, Van Mierlo LD, Meiland FJM, et al. The cost-effectiveness of two forms of case management compared to a control group for persons with dementia and their informal caregivers from a societal perspective. PLoS One. 2016;11:e0160908.CrossRef
17.
Reilly S, Malouf R, Hoe J, Toot S, Challis D, Orrell M. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1(1):CD008345.PubMed
18.
Joo JY, Liu MF. Effectiveness of nurse-led case management in cancer care: systematic review. Clin Nurs Res. 2019;28:968–91.PubMedCrossRef
19.
Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, et al. The effectiveness of disease and case management for people with diabetes: a systematic review. Am J Prev Med. 2002;22:15–38.PubMedCrossRef
20.
Joo JY, Huber DL. An integrative review of case management for diabetes. Prof Case Manag. 2012;17:72–85.PubMedCrossRef
21.
Boger EJ, Demain S, Latter S. Disability and rehabilitation self-management: a systematic review of outcome measures adopted in self-management interventions for stroke. Disabil Rehabil. 2013;35:1415–28.PubMedCrossRef
22.
Lukersmith S, Millington M, Salvador-Carulla L. What is case management? A scoping and mapping review. Int J Integr Care. 2016;16:1–13.CrossRef
23.
van Mierlo LD, MacNeil-Vroomen J, Meiland FJM, Joling KJ, Bosmans JE, Dröes RM, et al. Implementatie en (kosten-)effectiviteit van casemanagement voor mensen met dementie en hun mantelzorgers: resultaten van de COMPAS-studie. Tijdschr Gerontol Geriatr. 2016;47:223–33.PubMedCrossRef
24.
Lukersmith S, Fernandez A, Millington M, Salvador-Carulla L. The brain injury case management taxonomy (BICM-T); a classification of community-based case management interventions for a common language. Disabil Health J. 2016;9:272–80. Elsevier Inc.PubMedCrossRef
25.
Malec JF, Buffington ALH, Moessner AM, Thompson JM. Maximizing vocational outcome after brain injury: integration of medical and vocational hospital-based services. Mayo Clin Proc. 1995;70:1165–71.PubMedCrossRef
26.
Malec JF, Buffington ALH, Moessner AM, Degiorgio L. A medical/vocational case coordination system for persons with brain injury: an evaluation of employment outcomes. Arch Phys Med Rehabil. 2000;81:1007–15.PubMedCrossRef
27.
Ashley MJ, Persel CS, Lehr RP, Feldman B, Krych DK. Post-acute rehabilitation outcome: relationship to case-management techniques and strategy. J Insur Med. 1994;26:348–54.PubMed
28.
Heinemann AW, Corrigan JD, Moore D. Case management for traumatic brain injury survivors with alcohol problems. Rehabil Psychol. 2004;49:156–66.CrossRef
29.
Lannin NA, Laver K, Henry K, Turnbull M, Elder M, Campisi J, et al. Effects of case management after brain injury: a systematic review. NeuroRehabilitation. 2014;35:635–41.PubMedCrossRef
30.
Fens M, Van Heugten CM, Beusmans G, Metsemakers J, Kester A, Limburg M. Effect of a stroke-specific follow-up care model on the quality of life of stroke patients and caregivers: a controlled trial. J Rehabil Med. 2014;46:7–15.PubMedCrossRef
31.
Boter H. Multicenter randomized controlled trial of an outreach nursing support program for recently discharged stroke patients. Stroke. 2004;35:2867–72.PubMedCrossRef
32.
Mayo NE, Scott S. Evaluating a complex intervention with a single outcome may not be a good idea: an example from a randomised trial of stroke case management. Age Ageing. 2011;40:718–24.PubMedCrossRef
33.
Alzheimer Nederland & Vilans. Zorgstandaard dementie. 2013.
34.
Groenewoud H, Egers I, Pool A, de Jange J. Evaluatieonderzoek van de pilot casemanagement dementie in de regio Delft Westland Oostland 2005–2007. Rotterdam: Eindrapport; 2008.
35.
Huijsman R, Jansen G, Bolle F. Expertisegebied dementieverpleegkundige (voorheen casemanager dementie). Utrecht: V&VN; 2017.
36.
Ketelaar N, Jukema J, van Bemmel M, Adriaansen M, Smits C. Casemanagement dementie. Methodisch werken en positionering in de keten. Een werk- methodiek ontwikkeld door drie regionale dementieketens. Zwolle; 2015.
37.
de Lange J. Casemanager dementie: een complexe baan. Tijdschr voor Prakt. 2014;2:47–9.CrossRef
38.
de Lange J, Deusing E, Peeters J, Francke A, Pot AM. De kunst van casemanagement. Tien succesfactoren volgens mantelzorgers; 2013.
39.
Peeters JM, Francke AL, Pot AM. Organisatie en invulling van casemanagement dementie in Nederland. Verslaglegging van een landelijke peiling onder regionale projectleiders. Utrecht; 2011.
40.
Peeters, J., Werkman, W., & Francke AL. Dementiemonitor Mantelzorg: problemen, zorgbehoeften, zorggebruik en oordelen van mantelzorgers. Utrecht; 2012.
41.
Peeters JM, de Lange J, van Asch I, Spreeuwenberg P, Veerbeek M, Pot AM, Francke AL. Landelijke evaluatie van casemanagement dementie. Utrecht; 2012.
42.
Rijken, E., Jansen, P., Diermanse, I., & Ten Hove S. Casemanagement dementie: stand van zaken, knelpunten en oplossingen. Enschede; 2016.
43.
Verkade PJ, van Meijel B. Tien jaar casemanagement bij dementie. Tijdschr voor Verpleegkundigen. 2011;5:51–5.
44.
Verberne-Nuijten D, de Lange J. Casemanagement in de dementieketen. Rotterdam: Capelle en Krimpen aan den IJssel; 2014.
45.
Verkade PJ, Kuipers T, van Wees C, Mieremet W, Lenselink J. Expertisegebied casemanager dementie. Utrecht; 2012.
46.
Winters J. Expertiseprofiel casemanagers dementie sociaal werk zorg. Utrecht; 2018.
47.
Stiekema APMM, van Heugten CM, de Vugt ME. Joining forces to improve psychosocial care for people with cognitive deficits across diagnoses: social health as a common framework. Aging Ment Health. 2019;23:1275–81.PubMedCrossRef
48.
van Heugten C, Rasquin S, Winkens I, Beusmans G, Verhey F. Checklist for cognitive and emotional consequences following stroke (CLCE-24): development, usability and quality of the self-report version. Clin Neurol Neurosurg. 2007;109:257–62.CrossRefPubMed
49.
van der Zee CH, Visser-Meily JMA, Lindeman E, Jaap Kappelle L, Post MWM. Participation in the chronic phase of stroke. Top Stroke Rehabil. 2013;20:52–61.PubMedCrossRef
50.
Lambert MJ, Burlingame GM, Umphress V, Hansen NB, Vermeersch DA, Clouse GC, et al. The reliability and validity of the outcome questionnaire. Clin Psychol Psychother. 1996;3:249–58.CrossRef
51.
Spinhoven P, Ormel J, Sloekers PPA, Kempen GIJM, Speckens AEM, van Hemert AM. A validation study of the Hospital Anxiety And Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27:363–70.CrossRefPubMed
52.
Fugl-Meyer AR, Bränholm I-B, Fugl-Meyer KS. Happiness and domain-specific life satisfaction in adult northern swedes. Clin Rehabil. 1991;5:25–33.CrossRef
53.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the hospital anxiety and depression scale. J Psychosom Res. 2002;52:69–77.PubMedCrossRef
54.
Post MW, Van Leeuwen CM, Van Koppenhagen CF, De Groot S. Validity of the life satisfaction questions, the life satisfaction questionnaire, and the satisfaction with life scale in persons with spinal cord injury. Arch Phys Med Rehabil. 2012;93:1832–7.PubMedCrossRef
55.
Boonstra AM, Reneman MF, Stewart RE, Balk GA. Life satisfaction questionnaire (Lisat-9). Int J Rehabil Res. 2012;35:153–60.PubMedCrossRef
56.
Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the patient activation measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39:1005–26.PubMedPubMedCentralCrossRef
57.
Rademakers J, Nijman J, Van Der Hoek L, Heijmans M, Rijken M. Measuring patient activation in the Netherlands: translation and validation of the American short form Patient Activation Measure (PAM13). BMC Public Health. 2012;12:1.CrossRef
58.
Forster A. Validation of the longer-term unmet needs after stroke (LUNS) monitoring tool: a multicentre study. Clin Rehabil. 2013;27:1020–8.CrossRef
59.
Groeneveld IF, Arwert HJ, Goossens PH, Vliet Vlieland TPM. The longer-term unmet needs after stroke questionnaire: cross-cultural adaptation, reliability, and concurrent validity in a Dutch population. J Stroke Cerebrovasc Dis. 2018;27:267–75.PubMedCrossRef
60.
61.
Nederlandse Vereniging voor Neurologie. Herseninfarct en hersenbloeding. 2017.
62.
63.
Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002;6:153–60.PubMedCrossRef
64.
Lorig K, Holman HR. Self-management education: History, definition, outcomes , and mechanisms. Ann Behav Med. 2003;26:1–7.PubMedCrossRef
65.
Kreutzer JS, Wehman P. Community integration following traumatic brain injury. Baltimore: Brookes; 1990.
66.
Dalemans R, Overländer S, Knors A. Family needs questionnaire Vertaling naar het Nederlands, onderzoek naar de begrijpelijkheid: Logop en Foniatr; 2011. p. 82–6.
67.
Kreutzer JS, Serio CD, Bergquist S. Family needs after brain injury: a quantitative analysis. J Head Trauma Rehabil. 1994;9:104–15.CrossRef
68.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.PubMedPubMedCentralCrossRef
69.
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22:1717–27.PubMedCrossRef
70.
Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, et al. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Appl Health Econ Health Policy. 2013;11:155–61.PubMedCrossRef
71.
Rauwenhoff J, Peeters F, Bol Y, Van Heugten C. The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial. Trials. 2019;20:1–10.CrossRef
72.
Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005;6:134–47.PubMedCrossRef
73.
Moulaert VRMP, van Heugten CM, Winkens B, Bakx WGM, de Krom MCFTM, Gorgels TPM, et al. Early neurologically-focused follow-up after cardiac arrest improves quality of life at one year: a randomised controlled trial. Int J Cardiol. Elsevier B.V. 2015;193:8–16.PubMedCrossRef
74.
Rausch JR, Maxwell SE, Kelley K. Analytic methods for questions pertaining to a randomized pretest, posttest, follow-up design. J Clin Child Adolesc Psychol. 2003;32:467–86.PubMedCrossRef
75.
Hennink M. International focus group research. A handbook for the health and social sciences. Cambridge: University Press; 2007.CrossRef
76.
Patton M. Qualitative research & evaluation methods. 3rd ed. Thousands Oaks London New Delhi: SAGE Publications; 2002.
77.
78.
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15:1277–88.PubMedCrossRef
Metadata
Title
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
Authors
Annemarie P. M. Stiekema
Christine Resch
Mireille Donkervoort
Natska Jansen
Kitty H. M. Jurrius
Judith M. Zadoks
Caroline M. van Heugten
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Stroke
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04804-2

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial

Study protocol

Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial

Study protocol

Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Research

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

Research

A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)

Study protocol

Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial