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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.

Abstract：

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.

journal_name

BMC Health Serv Res

journal_title

BMC health services research

authors

Wynia K,Annema C,Nissen H,De Keyser J,Middel B

doi

10.1186/1472-6963-10-142

subject

Has Abstract

pub_date

2010-05-27 00:00:00

pages

142

issn

1472-6963

pii

1472-6963-10-142

journal_volume

pub_type

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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.