|- candidate number||23624|
|- NTR Number||NTR5677|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jan-2016|
|- Secondary IDs||2015.434 Medisch Ethische Toetsingscommissie (METC) VU Medisch Centrum|
|- Public Title||Empowerment in mental health care using e-health in a redesigned intake process|
|- Scientific Title||Empowerment in mental health care using e-health in a redesigned intake process: a cluster randomised controlled trial.
|- hypothesis||The aim of this study is to examine whether the implementation of a redesigned intake process using e-health is effective compared to the intake as usual without an e-health intervention.
The first hypothesis is that using e-health in a new intake method will lead to a higher degree of autonomous motivation of patients for psychiatric treatment and which may in turn lead to a beneficial shift in the empowerment of patients to play an active role in their own mental health and treatment.
Second hypothesis is that motivated and active involved patients have a more equivalent interplay with their clinician. Due to the empowerment of patients and equivalence in the working relationship between patients and clinicians the application of Shared Decision Making may be encouraged.
Third it is hypothesized that improvement in motivation, active involvement and an equivalent working relationship is positively related to patientís adherence to treatment and improved clinical outcome.
|- Healt Condition(s) or Problem(s) studied||Empowerment, E-health, Mental health care|
|- Inclusion criteria||Patients who are referred to one of the participating centers treating depression, anxiety and personality disorders, for whom a full intake is planned and who have sufficient command of the Dutch language, are eligible for participation and will be asked for written informed consent. |
|- Exclusion criteria||Exclusion criteria for participating in this study are patients who donít get a full intake because of a come back in treatment and patients who donít speak and read Dutch.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2016|
|- planned closingdate||1-apr-2017|
|- Target number of participants||172|
|- Interventions||The intake-teams randomised to the intervention group implement e-health interventions in a redesigned intake process. |
To implement this new way of working, the clinicians of the intervention teams follow a training aiming to gain insight, knowledge and skills in the application of recovery supported care, shared decision making and e-health with the purpose to motivate and empower patients in gaining an active role in their recovery and stimulating an equivalent interplay between patients and clinicians.
|- Primary outcome||The primary outcome measures are the degree in patient motivation for treatment and patient activation in mental health (treatment).|
|- Secondary outcome||The secondary outcome measures are quality of the patient-clinician relationship, process of Shared Decision Making, patientsí adherence to treatment and clinical outcome. |
|- Timepoints||Datacollection: September 2016-March 2017
Reporting of the results is expected from September 2017. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Margot Metz|
|- CONTACT for SCIENTIFIC QUERIES|| Margot Metz|
|- Sponsor/Initiator ||GGZ Breburg, EMGO Institute, VU University Medical Center, Vrije Universiteit Amsterdam, Tilburg University, Leiden University|
(Source(s) of Monetary or Material Support)
|- Publications||Article about studyprotocol in preparation. |
|- Brief summary||This study is designed to investigate the effectiveness of a redesigned intake process in specialised mental health care using e-health in a two-arm cluster randomised controlled trial. |
The study hypothesizes that this new way of working is positively related to: 1) a higher level of autonomous motivation and an more active role of patients in their mental health treatment, 2) greater equivalence in and quality of the working relationship between patient and clinician, 3) a higher level of the application of shared decision making and treatment adherence, and 4) better clinical outcomes.
|- Main changes (audit trail)|
|- RECORD||17-jan-2016 - 31-mrt-2016|