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Effective and efficient care for patients with anxiety disorders and/or depression in primary care.


- candidate number6103
- NTR NumberNTR1912
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2009
- Secondary IDs171003004  ZonMw
- Public TitleEffective and efficient care for patients with anxiety disorders and/or depression in primary care.
- Scientific TitleThe effect of tailoring on the implementation of guideline recommendations for the recognition, diagnosis and allocation of care for patients with anxiety disorder and/or depression in primary care.
- ACRONYMN/A
- hypothesisAnxiety disorders and depression are common illnesses that have a negative impact on everyday functioning, cause great suffering, and entail both high care costs and loss of production. Recognition, diagnosis and stepped care allocation of treatment in primary care could be improved. For both disorders national guidelines excist and following guidelines can lead to significant reduction of the burden of disease, significantly greater symptom reduction and improvement of social functioning. Adherence to guidelines should be improved.
There can be several barriers which hinder the adherence to guidelines. There is relatively little known about which implementation strategies are effective in which context.
This study is based on the hypothesis that the implementation strategy offered should be sufficiently aligned with specific characteristics and barriers in the local context.
The objective of this study is to improve the quality of care and outcomes for patients with anxiety disorders and depression and to acquire knowledge and insight into the effect of tailored strategies focused on the implementation of guideline recommendations for the recognition, diagnosis and stepped care allocation in primary care for patients of 18 years and older with a first or new episode of anxiety disorders and/or depression.
- Healt Condition(s) or Problem(s) studiedDepression, Anxiety disorders
- Inclusion criteriaThe criteria for the inclusion of patients are:
1. Patients from 18 years and older whose first score on the Dutch version of the extended Kessler-10 (EK-10) is 20 or higher and/or at least once a yes on the added questions 11 till 16;
2. Adequate knowledge of the Dutch language;
3. Able to complete questionnaires.

The criteria for the inclusion of general practitioners are:
1. Participate in a training;
2. Motivated to perform screening with the Four-dimensional Symptom Questionnaire (4DSQ), stepped care diagnostics and allocation, psychoeducation;
3. The use of a GP Information System (HIS) and the capability to register data;
4. Monitor treated patients;
5. Filling in questionnaires about experienced barriers and used implementation strategies;
6. Agree with an on-site supervision visit.
- Exclusion criteriaNone.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate1-dec-2012
- Target number of participants572
- InterventionsThe interventions to be implemented in both groups are derived from the national guidelines for anxiety disorders and depression and comprise the phase of recognition, diagnosis and needs assessment for stepped care. Both groups get information about the interventions. The selected interventions are:
1. Structural use of a screening instrument, the Four-dimensional Symptom Questionnaire (4DSQ), for high-risk patients. Criteria are described in the national guidlines;
2. Making the diagnosis and recording this in the General Practitioner Information System;
3. Discussion of the diagnosis and treatment options with the patient and providing psycho-education to diagnosed patients in accordance with the protocol;
4. Making the distinction between mild/non-complex problems and severe/complex problems and determining suitable initial treatment on this basis (stepped care allocation), in consultation with the patient. This is minimal treatment in the case of mild problems and medication or psychotherapy for people with severe problems.

Tailoring of strategies:
In the first months of the project, a list will be prepared of possible barriers to better screening, diagnosis, the provision of information and needs assessment for stepped care in the general practice. The digital barrier list will be used to carry out the analysis of the local context with the general practitioners in the intervention group. Barriers will be coupled directly to concrete strategies, creating combinations of strategies that are geared to the local context.
- Primary outcomeAssessment at the cluster level of recognition of anxiety or depression by the GP in patients screened positive on the EK-10.
- Secondary outcomeOutcomes at the patient level:
1. Change in the symptoms of anxiety and depression measured with the Four-dimensional Symptom Questionnaire; the 4DSQ. 2. Change in functioning, measured with the WHO-DASS;
2. Experiences with the care, measured with the QUality Of care Through the Eyes of the patient scale (QUOTE).;
3. Care utilization, illness and work measured with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).
Outcomes at general practitioner level are: 1. Increase in registered diagnoses of anxiety and depression; 2. Change in anti-depressant prescribing, number of references, number of consultations for anxiety and depression.
- Timepoints1. At patientlevel: at baseline, 3 and 6 months;
2. At GP level: data on outcomes were gathered from a retrospective patient medical record search, which took place between 6 months before and 6 months after patients completed the EK-10.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Henny Sinnema
- CONTACT for SCIENTIFIC QUERIES Henny Sinnema
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Radboud University Medical Center Nijmegen, VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryGoal: To acquire knowledge and insight into the effect of tailored strategies focused on the implementation of guideline recommendations for the recognition, diagnosis and stepped care allocation in primary care for patients of 18 years and older with a first or new episode of anxiety disorders and/or depression, to achieve better outcomes and more efficient use of implementation strategies.
Design: randomised controlled trial with two-arms perform in 40 general practitioner practices. Clusterrandomisation. Measurs at baseline, 6, and 24 months after inclusion. A process evaluation is carried out to acquire knowledge about how tailoring of implementation strategies deal with implementation barriers by professionals and in the organizational context.
Study population: patients who visit the general practitioner and by whose first score on the Dutch version of the extended Kessler-10 (EK-10) is 20 or higher and/or at least once a yes on the added questions 11 till 16.
Interventions:
1. The structural use of a screening instrument, the Four-dimensional Symptom Questionnaire;
2. Making the diagnosis and recording this in the General Practitioner Information System;
3. Making the distinction between mild- and severe problems;
4. Discussion of the diagnosis and treatment options with the patient and providing psycho-education to diagnosed patients.
Implementation strategies: depending on the barriers for successful implementation strategies are being tailored.
Outcome measures: Primary outcome measurement is change in the symptoms of anxiety and depression measured with the Four Dimensional Symptom Questionnaire.
Sample size calculation/data analysis: based on a power calculation we have to include 572 patients. All analyses will be conducted in accordance with the intention-to-treat principle. Patients are recruited in the Netherlands.
Economic evaluation: in the economic evaluation we will study both the costs and benefits of tailored strategy in comparison with the control group.
- Main changes (audit trail)31-3-2014: Change of primary outcome (was " Outcomes at the patient level are:
Change in the symptoms of anxiety and depression measured with the Four-dimensional Symptom Questionnaire; the 4DSQ.

Outcomes at general practitioner level are:
1. Increase in the number of patients who have been given the 4DQS as screener;
2. Increase in registered diagnoses of anxiety and depression;
3. Increase in stepped care allocation;
4. Change in anti-depressant prescribing, number of references, number of consultations for anxiety and depression.")
Change secondary outcome:
- Added "1. Change in the symptoms of anxiety and depression measured with the Four-dimensional Symptom Questionnaire; the 4DSQ."
- Changed "questions from the Consumer Quality Index (CQ Index)" into "the QUality Of care Through the Eyes of the patient scale (QUOTE)"
- Added outcomes at general practioner level.
Change of time points: at patient level was "baseline, 6 and 12 months", at GP level was "baseline, 6 and 24 months) - AB
- RECORD15-jul-2009 - 31-mrt-2014


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