|- candidate number||10340|
|- NTR Number||NTR3105|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-sep-2011|
|- Secondary IDs||300020011 ZonMw|
|- Public Title||Use of an electronic patient decision aid to support Shared Decision Making and treatment planning in psychotic disorders.(NL: Samen Keuzes Maken).|
|- Scientific Title||Use of an electronic patient decision aid to support Shared Decision Making and treatment planning in psychotic disorders.|
|- hypothesis||We expect the intervention group to be more satisfied with the treatment planning process compared to the control group.|
|- Healt Condition(s) or Problem(s) studied||Schizophrenia, Decision Support System (Clinical), Shared decision making, Psychotic disorders, E-health|
|- Inclusion criteria||1. Psychiatric outpatients diagnosed with a psychotic disorder;|
2. Age 18-65 years;
3. Fluent in Dutch.
|- Exclusion criteria||Patients with HoNOS score >= 15 for at least 1 month or in crisis.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2011|
|- planned closingdate||31-dec-2012|
|- Target number of participants||200|
|- Interventions||Intervention group:|
Treatment planning in a shared decision making process, supported by an electronic patient decision aid.
The electronic decision aid supports clients in getting an overview of their care needs and of the treatment modules provided by GGZ Friesland. The decision aid is a piece of software, consisting of three parts:
1. A questionnaire (based on the items of the CANSAS-P) about care needs that patients can fill out;
2. A digital catalogue with an overview of treatment modules, including a description of the content, duration, professionals involved and a description of problems/symptoms the treatment module is usually indicated for;
3. A section in which clients can indicate their personal preferences for treatment modules (by means of a checkbox). After having use the decision aid, clients can print an overview of their preferences and take this print to the next meeting with their clinician, in which the treatment planning will be discussed.
The control group receives standard care (ie no use of the patient decision aid).
|- Primary outcome||Patient satisfaction with treatment planning process, measured with a satisfaction questionnaire developed for this trial. (The questionnaire is a combination of items from, among others, the COMRADE and the CSQ).|
|- Secondary outcome||1. Patient preference for autonomy (API);|
2. HoNOS scores;
3. Care consumption;
4. Number of undesirable events including crisis-contacts, medication non-compliance, no shows, BOPZ procedures and increase in medication dosage.
|- Timepoints||1. T0 baseline;|
2. T1 after 6 months;
3. T2 after 12 months;
4. The study duration will be one year (2 x 6 months).
All measurements, except for the Autonomy Preference Index and the Satisfaction Questionnaire, can be obtained from ROM research or retrieved from the Electronic Patient File, meaning that this data would also be collected in the absence the present experiment.
|- Trial web site||http://development.wegweis.nl/|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.A.J. Krieke, van der|
|- CONTACT for SCIENTIFIC QUERIES|| J.A.J. Krieke, van der|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Rob Giel Research Center for Mental Health Services Research , GGZ Friesland|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Psychotic disorders are among the most severe and disabling mental disorders, characterized by abnormalities in the perception of reality and cognitive functioning (American Psychiatric Association, 1994). They generally lead to significant social and occupational dysfunction. The lifetime prevalence is estimated as 1% of the population. Dutch mental health institutions provide a broad array of evidence based interventions for psychotic disorders (i.e. schizophrenia), and in the North of the Netherlands this has led to the development of specific disease management protocol. However, even within such protocols the care system still is mainly driven by supply in stead of by the needs of users. The delivery of care and the selection of specific interventions is insufficiently based on individual demands and needs, even more alarming, it certainly does not reflect a model of shared decision making (SDM).
GGZ Friesland recently launched a new disease management protocol for the treatment of people with psychotic disorders, in which SDM is designated as a proper method for treatment planning. According to the protocol, clinicians and clients are supposed to each give their input as to which treatment modules they deem adequate and acceptable.
There are, however, two matters that seem to hamper a genuine process of SDM in the treatment planning at GGZ Friesland. Firstly, clients usually do not have access to their test results, after having completed a needs questionnaire. Secondly, clients usually are not well informed about the different treatment modules offered by the organization. In other words: they do not know what modules they can choose from. As a consequence, the SDM process in the current health care planning and treatment protocol of GGZ Friesland is not as strong as it can be.
In an attempt to tackle the obstacles and to strengthen SDM, we have developed an electronic patient decision aid to. support patients in getting an overview of their care needs and of the treatment modules provided by GGZ Friesland This experiment aims to test the effectiveness of this tool in supporting the SDM process.
|- Main changes (audit trail)|
|- RECORD||13-sep-2011 - 26-okt-2011|