|- candidate number||8681|
|- NTR Number||NTR2612|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-nov-2010|
|- Secondary IDs||171101012 ZonMW, VEMI subsidie|
|- Public Title||Measuring the effectiveness and efficiency of a communication training for medical specialists focused on patients with medically unexplained physical symptoms (MUPS).|
|- Scientific Title||Effectiveness and efficiency of a consultation skills training programme for medical specialists focused on patients with medically unexplained physical symptoms (MUPS).|
|- ACRONYM||MUPS training for medical specialists|
|- hypothesis||Training medical specialists in consultation skills focused on MUPS patients improves the specialistic care for these patients in terms of illness worries, course of symptoms and daily functioning and reduces the medical costs for this patient group.|
|- Healt Condition(s) or Problem(s) studied||Medically unexplained physical symptoms, Communication, Cost-effectiveness , Education, Consultation skills training, Medical specialists, Illness worries|
|- Inclusion criteria||Adult outpatients with MUPS, diagnosed by the participating specialist.|
|- Exclusion criteria||1. Age < 18 years;|
2. Not able to comprehend Dutch;
3. Legally incapable.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-apr-2013|
|- Target number of participants||720|
|- Interventions||Consultation skills training programme for medical specialists focused on patients with MUPS.|
The programme consists of 4 training sessions with an interval of 4 to 6 weeks, in groups of 12 persons with 2 experienced trainers.
Training 1 consists of exploring complaints of patients on all aspects of SCEBS (Somatic, Cognitive, Emotion, Behaviour, Social environment).
In Training 2, informing the patient is the central subject (seek connection with his language etc). Explaining the conditions that maintain the current condition (vicious circles), registration of complaints and reattribution.
Training 3 treats techniques for tough anxiety (stop reassuring, interrogate catastrophic ideas, etc) and ways of refering and reporting back to the GP.
Training 4 gives space for presenting casuistry, where the doctor has worked with the new techniques.
The control group receives no training.
|- Primary outcome||On patient-level we measure with questionnaires:|
1. Illness worries with Whiteley Index;
2. Current symptom severity with VAS;
3. Distress, depression, anxiety and somatisation with 4-DSQ;
4. Daily functioning of patients with SF-36.
The questionnaires will be taken at baseline, after 3 months and after 6 months.
|- Secondary outcome||On doctor-level we measure the application of consultation skills by observation of video-taped consultations and facts from patientfiles.|
An economic evaluation will be performed from societal perspective. Costs of the training programme, health care utilization, personal expenses and production loss will be measured. The research team registers the costs of intervention; we measure the other volumina by patient questionnaires.
|- Timepoints||1. Months 1-2: Preparation;|
2. Months 3-20: Datacollection and intervention;
3. Months 21-24: Data-analysis and report.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. Anne Weiland|
|- CONTACT for SCIENTIFIC QUERIES||Dr. L.R. Arends|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Internal Medicine , VU University Medical Center, EMGO+ Institute, NIVEL|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Rotterdam, ZON-MW, The Netherlands Organization for Health Research and Development, Fonds Nuts-Ohra, CZ Fonds|
|- Brief summary||To improve medical specialistic care for patients with medically unexplained physical symptoms (MUPS) by developing and researching the effectiveness and efficiency of a consultation skills training programme for medical specialists focused on MUPS-patients.|
|- Main changes (audit trail)|
|- RECORD||18-nov-2010 - 4-dec-2010|