|- candidate number||22383|
|- NTR Number||NTR5262|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jun-2015|
|- Secondary IDs||METC VUMC 2015.237 WC EMGO VUMC, number will be expected|
|- Public Title||Shared Decision Making in Mental Health
with Routine Outcome Monitoring (ROM) as an information source. |
|- Scientific Title||Shared Decision Making in Mental Health
with Routine Outcome Monitoring (ROM) as an information source.
A cluster randomised trial in Breakthrough ROM teams
|- hypothesis||In this study, we aim to research the appliance of ROM in Shared Decision Making about treatment options between client and practitioner. We will compare two different conditions. In one condition, the Breakthrough-intervention teams, Shared Decision Making with ROM will have been implemented before this study will start. In the other condition, the Shadow-control teams will implement Shared Decision Making with ROM in a later phase, after data collection for this study.
The primary outcome measure will be the client’s perception of shared decision making.
The secondary outcome parameter will be the client-practitioner relationship. Additionally we will investigate the influence on the client’s commitment to the treatment. Depends on the patient population we also look at the effects on the reduction of symptoms, the improvement of functioning in the society or quality of live. Overall we expect positive effects on the primary, secondary and additional outcome parameters in the Breakthrough teams which will implement shared decision making with ROM at first.
|- Healt Condition(s) or Problem(s) studied||Shared decision making|
|- Inclusion criteria||Teams which are participating in the Dutch Breakthrough ROM network (project). |
Inclusion of clients which are receiving treatment (through the participating teams/practioners) and will give informed consent.
|- Exclusion criteria||Clients who are nog able to speak and read Dutch. |
Clients who don't agree with participating in the study (no informed consent)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2015|
|- planned closingdate||1-jun-2016|
|- Target number of participants||364|
|- Interventions||Appliance of Routine Outcome monitoring in Shared Decision Making about treatment options between client and practitioner. |
Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, using standardized instruments, aiming to evaluate and, if necessary, adapt treatment.
Breakthrough, intervention teams, receive training in SDM & ROM model, support and coaching in the implementation.
|- Primary outcome||The client’s perception of shared decision making|
|- Secondary outcome||Client-practitioner relationship|
Client’s commitment to the treatment
Reduction of symptoms, the improvement of functioning in the society or quality of live
|- Timepoints||Three measurement points in 6 months:|
T0 (baseline), T1 (+/- 3 months), T2 (+/- 6 months)
Inclusion patients in 3-4 months
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||drs. Metz Margot|
|- CONTACT for SCIENTIFIC QUERIES||drs. Metz Margot|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Network for Quality Development in the Mental Health|
|- Publications||not yet|
|- Brief summary||Although up to now results of Shared Decision Making in mental health are comparable with physical health settings, few studies have been conducted in mental health. Besides the appliance of ROM as an information source in Shared Decision Making between client and practitioner is an innovative intervention in mental health. To our knowledge research to the usage of ROM in Shared Decision Making has not been available yet. One of the purposes of the Dutch Breakthrough ROM-project, funded by the Network for Quality Development in the Mental Health, is to implement ROM as a source in Shared Decision Making by teams in Mental Health Organisations and self-employed practitioners. Because there is little known about the effects of this intervention, it is desirable to evaluate the effects of the implementation of ROM as a tool in Shared Decision Making. In this study, we aim to research the appliance of ROM in Shared Decision Making about treatment options between client and practitioner. |
|- Main changes (audit trail)|
|- RECORD||24-jun-2015 - 16-aug-2015|