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Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

BACKGROUND: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is lit...

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Autores principales: Wynia, Klaske, Annema, Coby, Nissen, Hans, De Keyser, Jacques, Middel, Berrie
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890641/
https://www.ncbi.nlm.nih.gov/pubmed/20507600
http://dx.doi.org/10.1186/1472-6963-10-142
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author Wynia, Klaske
Annema, Coby
Nissen, Hans
De Keyser, Jacques
Middel, Berrie
author_facet Wynia, Klaske
Annema, Coby
Nissen, Hans
De Keyser, Jacques
Middel, Berrie
author_sort Wynia, Klaske
collection PubMed
description BACKGROUND: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS) patients and their caregivers compared to usual care. METHODS/DESIGN: In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. DISCUSSION: This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1) the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2) we included patients with complex care situations and/or were at risk for critical situations; 3) the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4) case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5) the case managers had a regional network of professionals and health care organisations at their disposal, and were accepted as a coordinator of care. We also put a lot of effort on the selection of eligible patients, randomization and statistical methods, but also on power analysis, selection of reliable, validated and sensitive outcome measures, and (statistical) control of confounders. TRIAL REGISTRATION: Dutch Trial Register http://www.trialregister.nl. Trial ID: NTR762.
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spelling pubmed-28906412010-06-24 Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients Wynia, Klaske Annema, Coby Nissen, Hans De Keyser, Jacques Middel, Berrie BMC Health Serv Res Study protocol BACKGROUND: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS) patients and their caregivers compared to usual care. METHODS/DESIGN: In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. DISCUSSION: This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1) the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2) we included patients with complex care situations and/or were at risk for critical situations; 3) the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4) case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5) the case managers had a regional network of professionals and health care organisations at their disposal, and were accepted as a coordinator of care. We also put a lot of effort on the selection of eligible patients, randomization and statistical methods, but also on power analysis, selection of reliable, validated and sensitive outcome measures, and (statistical) control of confounders. TRIAL REGISTRATION: Dutch Trial Register http://www.trialregister.nl. Trial ID: NTR762. BioMed Central 2010-05-27 /pmc/articles/PMC2890641/ /pubmed/20507600 http://dx.doi.org/10.1186/1472-6963-10-142 Text en Copyright ©2010 Wynia et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study protocol
Wynia, Klaske
Annema, Coby
Nissen, Hans
De Keyser, Jacques
Middel, Berrie
Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title_full Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title_fullStr Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title_full_unstemmed Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title_short Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
title_sort design of a randomised controlled trial (rct) on the effectiveness of a dutch patient advocacy case management intervention among severely disabled multiple sclerosis patients
topic Study protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890641/
https://www.ncbi.nlm.nih.gov/pubmed/20507600
http://dx.doi.org/10.1186/1472-6963-10-142
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