|- candidate number||10489|
|- NTR Number||NTR3150|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-nov-2011|
|- Secondary IDs||10-462 UMCU|
|- Public Title||Early Diagnostics of Depression in Primary Care.|
|- Scientific Title||Early Diagnostics of Depression in Primary Care.|
|- ACRONYM||Early Diagnostics of Depression |
|- hypothesis||Which of two strategies for early detection of depression in primary care performs best, i.e. results in higher number of identified depressions. The two strategies are:|
1. Active case finding of high risk patients by a nurse practitioner;
2. Routing of high risk patients in electronic dossiers of the general practitioner.
|- Healt Condition(s) or Problem(s) studied||Depression, Early diagnostics|
|- Inclusion criteria||All patients in primary care between 18 and 70 years old.|
|- Exclusion criteria||1. A current diagnosis of depression (ICPC-code P96 in the last 6 months);|
2. Current use of antidepressives (ATC-code N106A in the last 3 months);
3. A diagnosis of schizophrenia (ICPC-code P72), affective psychosis (P73), or bipolair disorder (P99), or suicide attemt (P77).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-jan-2012|
|- planned closingdate||15-nov-2013|
|- Target number of participants||32000|
|- Interventions||The first strategy involves a nurse practitioner (POH-GGz) who actively approaches (by phone) highrisk patients on account of the general practitioner. The POH-GGz makes an inventory of complaints using the 4DKL. When suspecting a diagnosis of depression, a diagnosis may be made together with the general practitioner and treatment as usual is provided.|
In the second strategy, the general practitioner is informed about the patient being at highrisk for depression by active routing in the EMR. The general practitioner will provide diagnostics and treatment during regular consultation (care as
|- Primary outcome||The number of depressive complaints and the number of diagnosed depressions in the year follow-up (cumulative year incidence) on the basis of ICPC codes from the routine care records (EMD) of the LRJG.|
|- Secondary outcome||1. Number of prescribed anti-depressives (ATC-code N106A) in the year follow-up;|
2. Number of psychological treatments in the year follow-up;
3. Number of referrals to secondary care (psychiatry) in EMD in the year follow-up;
4. Number of complaints in P-category of the ICPC code;
5. Direct medical costs.
|- Timepoints||Interventions will run for 1 year. After a year we will measure the primary and secondary outcomes during the year of intervention. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Lidewij Wind|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. N.J. Wit, de|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Agis Health Insurance |
|- Brief summary||Depression is one of the top five diseases with the highest diseaseload. If untreated, depression has a large impact on quality of life and brings high costs for society.|
Structured early detection of high risk patients is an important strategy to reduce the disease load of mood disorders in primary care. Early detection of non-diagnosed depression in primary care and care for high risk patients in primary care may reduce the development of depression. This will result in a reduction of caseload and costs of care.
It is important to evaluate different strategies for early detection to learn which intervention has the best results and can be incorporated in primary care on a larger scale in the future.
In this randomised clinical trial design we will compare two strategies for early detection of depression in highrisk patients.
Our objective is to determine which of two strategies for early detection of depression in primary care performs best, i.e. results in higher number of identified depressions. The two strategies are: 1) active case finding by a nurse practitioner and 2) routing of high risk patients in electronic dossiers of the general practitioner.
The study involves a randomised trial design; we compare two strategies for a period of 1 year. In two Leidsche Rijn Julius healthcarecenters (LRJG) (Parkwijk and Terwijde, n = 16.000) identified high-risk patients (by known risk factors for
depression) will be randomised on practicelevel. In two other LRJG centers (Vleuterweide and Velthuizen, n = 16.000) we do nothing, as to be able to control for possible time-trends.
Highrisk individuals are detected on the basis of known riskfactors for depression from the PREDICT study (King ea 2008).
|- Main changes (audit trail)|
|- RECORD||1-nov-2011 - 28-nov-2011|