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 guidelineā¦
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measurement at general practitioner level is:
1. Change in the number of patients who have been given the 4DQS as screener.
Secondary outcome
Other secondary outcomes are:
At patient level:
2. Change in the symptoms of anxiety and depression measured with the Four
Dimensional Symptom Questionnaire, the 4DSQ.
3. Change in functioning, measured with the WHO-DASS;
4. Experiences with the care, measured with the Quality Of care Through the
patient's Eyes (QUOTE, CQIndex)
5. Quality-of-life measured with the EuroQol (EQ-5D)
6.Care utilization, illness and work measured with the Trimbos/iMTA
questionnaire for Costs associated with Psychiatric Illness (TiC-P/prodisq).
At general practitioner level
7. Increase in registered diagnoses of anxiety and depression;
8. Change in anti-depressant prescribing, number of references, number of
consultations for anxiety and depression.
Background summary
Anxiety disorders and depression are 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 implementationstrategies are effective
in which context. This study is based on the hypothesis that the
implementationstrategy offered should be sufficiently aligned with specific
characteristics and barriers in the
local context.
Study objective
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.
The central questions of the study are the following:
1. Does an implementation strategy tailored to address identified barriers to
change lead to more guideline-led care with better outcomes for patients with
anxiety disorders and/or depression in general practice, as compared with an
implementation strategy not tailored to barriers?
2. How can a tailored implementation strategy eliminate the barriers identified
in care professionals and in the organization of care?
3. Does implementation with a tailored strategy lead to more efficient care
than an implementation strategy that is not tailored?
Study design
A randomised controlled trial (RCT) will be conducted to test the effects of a
tailored implementation in mental health primary care. This is a two-arm study
with two parallel groups, viz. an intervention group with a tailored
implementation strategy and a control group with an implementation strategy
that is not tailored, meaning that pre-identified barriers are not taken into
consideration. In addition, a process evaluation will take place among the care
professionals and experts involved concerning the manner in which the tailoring
was effected, the relevant influencing factors and experiences with the
strategy. The implementation costs and yields in both study groups will be
calculated and compared in a limited
economic evaluation.
Intervention
The 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. The selected
interventions are the following:
1. Structural use of a screening instrument, the Four-dimensional Symptom
Questionnaire (4DKL), 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.
Study burden and risks
Not applicable.
Postbus 725
3500 AS Utrecht
NL
Postbus 725
3500 AS Utrecht
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28350.097.09 |
Other | TC=1912 |