Implementation study ADHD-Tornadoproject.|
|- candidate number||8444|
|- NTR Number||NTR2505|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-sep-2010|
|- Secondary IDs||80-823159710002 ZonMW |
|- Public Title||Implementation study ADHD-Tornadoproject.|
|- Scientific Title||Improving patient care for uncomplicated ADHD in children and adolescents by organisational redesign and enhanced collaboration between psychiatry and general practice. |
|- hypothesis||Problem: |
Although it is considered essential to implement the national guidelines for diagnostics and treatment in children and adolescents with ADHD, it is acknowledged to be more difficult in daily practice. In 2008 the Inspection of Healthcare established an ad-hoc working-party of experts their opinion on signals published in the media about over/underdiagnosing, treatment delay, and inappropriate treatment of children and adolescents with ADHD. The latter is even more worrisome since in the period 1996-2006 a remarkable increase of ADHD-medication in 0-19 year old is found: 2,6- to 19,5 per 1000. An explanation for inappropriate prescribing of medication is that because of the long waiting list in the child and adolescent Mental Health, general practitioners are
tempted to tune in and prescribe the medication themselves. The 2005 Guideline does not give applicable advises to the general practitioner for diagnosing and treating ADHD in children and adolescents. When it is being considered that ADHD in children and adolescents in the meantime is being called "common illness" it now seems necessary to develop methods in which general practitioners can contribute to the diagnosing and treatment of uncomplicated ADHD in children and adolescents. GPs have much experience in providing chronic care, but not for ADHDH. Our aim is that children and adolescents are helped sooner and the psychiatrists can focus on the more complicated cases. The (sub-)group of patients, targeted in this proposal are ADHD (Attention Deficit Hyperactivity Disorder, DSM-IV codes 314.01 and 314.00) in children and adolescents (6-15 year-olds),
uncomplicated and without comorbidity. This study aims to determine the effectiveness and efficiency of a program to implement prevailing guidelines for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents (the ADHD-Tornadoprogram). We expect that health outcomes (ADHD symptoms) will be at least the same, if not better, in the new program. We expect to reduce waiting time to specialist care so these health outcomes will be achieved quicker. However, further exploration of the cost consequences is required for a complete economic evaluation.
|- Healt Condition(s) or Problem(s) studied||Children, Adolescents, ADHD|
|- Inclusion criteria||Children and adolescents (age 6-15 years) with, at referral by their GP, suspicion of uncomplicated ADHD (Attention Deficit Hyperactivity Disorder, DSM-IV codes 314.01 and 314.00).
|- Exclusion criteria||Children and adolescents (age 6-15 years) with, at referral tot University Cluster of Karakter by their GP, suspicion of uncomplicated ADHD (Attention Deficit Hyperactivity
Disorder, DSM-IV codes 314.01 and 314.00) but who appear, after further study of their characteristics and complaints by the admission-coordinator, to have a more complicated (e.g. with psychiatrical or somatic co-morbidity and/of serious family-problems) form of AHDH.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||90|
|- Interventions||Implementation intervention. The ADHD implementation program, which has been successfully pilot tested in Nijmegen, focuses on children and adolescents with uncomplicated ADHD. It has two key components: Organizational redesign at the mental health centre, so that time between referral and start of treatment is substantially reduced; and enhanced collaboration between psychiatry and general practitioners, by providing short online courses for the GPs of referred patients. To make this intervention as recommended by the multidisciplinary ADHD guideline, the following procedures are implemented in patient care: |
1. Triage of these referred patients to confirm the suspicion of uncomplicated ADHD;
2. Short procedures for diagnostic process (shorter than current usual care);
3. Start of appropriate pharmaceutical treatment and other treatment, by the child psychiatrist;
4. Monitoring and follow-up of the treatment results, by the child psychiatrist (usual care) or GP (intervention group);
5. Focused parent training in 4 sessions in the study centre.
Control-condition (care as usual for children and adolescents with ADHD): Referred patients suspected of uncomplicated ADHD are selected.
The following procedure will start:
1. They will get a regular intake and diagnostic proces in the outpatient clinic of Karakter. This standard procedures consists of: anamnese en hetero-anamnese with limited developmental anamnese, an assessment by a child and adolescent psychiatrist and;
2. When necessary an extended developmental anamnese, neuropsychological assessment, family assessment and contact with school about the school functioning of the child;
3. After these assessements there will be an appointment with the child and adolescent psychiatrist who will explain the results and give advice about further treatment.
This diagnostic traject will take, in general, 6 to 12 weeks.
4. The child and adolescent psychiatrist will start the suitable farmacotherapy;
5. Monitoring en follow up of this farmacotherapy will be done by the child- and adolescent psychiatrist;
6. Focused parent training in 8 sessions in the control centre or individual sessions of parent training (length of training depending on severity of problems and treatment-results).
Mean length of individual parent training: 12 sessions in half a year time.
|- Primary outcome||Primary outcome: Time between referral to the mental health centre and start of treatment. We will examine: |
1. Duration of waiting time, between referral and actual start of the diagnostic process;
2. Duration of run time/lead time of the diagnosis and the start of treatment.
|- Secondary outcome||1. ADHD status: The functional status of the patients will be measured with the HoNOSCA. The HoNOSCA provides a global measure of an individuals current mental health status. Time Points: T1,T2,T4,T5,T7;|
2. Treatment adherence is measured by using the Morisky Adherence Scale to provide a brief screening
measurement of adherence with treatment response options. To measure the treatment adherence regarding the parent training, their appearance will be registered and parents will be asked ( by a brief, self-composed questionnaire at the end of the training) if they consider the parent-training useful and to what extend they apply what they learned in this training. Timepoints: T5, T6, T7;
3. Parents and patients are asked about their experiences (using the Trimbos Thermometer), study and control group are compared. Timepoints: T3 and T7;
4. Semi-strucured telephone interviews with GPs in the study group are done to assess their experiences with the ADHD-program. Focus will be on:
A. Their opinion and experience with respect to the referral process (forth and back), compared to usual
B. Do the involved GPs (in the ADHD-program and control group) feel themselves competent enough
to prescribe abd monitor ADHD-medication?
C. Do the GPs involved in the ADHD-program think that the course, given by our ADHD-specialist, about
prescribing and monitoring medication for ADHD is effective? Is their a difference in their feeling of competence before and after the course?
Semi-structured interviews with the involved professionals in the Karakter University Cluster regarding their experiences in this program, with particularly respect to the referral proces between general practitioners and specialists, compared to care as usual. Timepoint: T7;
5. The clinical indicator measuring the ADHD symptoms before and after treatment by using the ADHD-Ratingscale
Timepoints: T1, T2, T4, T5, T7;
6. Economic evaluation:
Objectives: The economic evaluation aims to determine the efficiency of the ADHD-program in comparison to the control group for the observed period (using observed costs and outcomes). The primary question is, what the cost consequences are per unit improvement on the primary outcome, that is reduction of time between referral and start of treatment. Indicators: EQ5D (child- and proxyversion) and Tic-P (proxy-version). Timepoints EQ5D: T1, T2, T4, T5, T6, T7. Timepoints Tic-P: T4 and T7.
|- Timepoints||T1= Referral by GP;|
T3= End of diagnostic phase;
T4= Start farmacotherapy;
T5= 6 weeks after start farmacotherapy;
T6= 9 months after T1;
T7= 1 year after T1.
|- Trial web site||www.karakter.com, direction: tornadopoli|
|- CONTACT FOR PUBLIC QUERIES|| Mijnke M.M. Janssen|
|- CONTACT for SCIENTIFIC QUERIES|| Mijnke M.M. Janssen|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Country of recruitment: The Netherlands.
This study aims to determine the effectiveness and efficiency of a program to implement prevailing guidelines for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents (the 'ADHD-program').
Cluster trial in 6 treatment teams at two sites, with a comparative before-after design. Patients in Nijmegen suspected of uncomplicated ADHD are selected from the group referred patients to our outpatient-clinic (n=3 treatment teams). The control-group consists of patients from the Karakter Cluster Gelderland (Arnhem and Doetinchem) outpatient-clinic children and adolescent psychiatry (n=3 treatment teams). They receive care as usual.
Children and adolescents (6-15 year- olds) with uncomplicated ADHD and their parents. Their parents are involved in the study for reporting on symptom-monitoring, satisfactory experience and treatment adherence for medication and the parent-training component of the ADHD
program. Professionals, such as General Practitioners and the professionals of the Karakter Nijmegen Centre
involved in this program, comprise another study population.
Intervention to be implemented:
Diagnostic and therapy, as recommended in the multidisciplinary ADHD guideline.
Implementation intervention. The ADHD implementation program, which has been successfully pilot tested in Nijmegen, focuses on children and adolescents with uncomplicated ADHD. It has two key components: Organizational redesign at the mental health centre, so that time between referral and start of treatment is substantially reduced; and enhanced collaboration between psychiatry and general practitioners, by providing short courses for the GPs of referred patients.
Sample size and statistical power:
The study is powered to to detect a difference of 36 days in the time between referral to mental health centre and start of medical treatment. Taken into account clustering in
the data, we aim to recruit a total of 162 patients (81 at each site, each with 3 teams who provide 27 patients).
|- Main changes (audit trail)||19-sep-2014: Changes |
- In- and exclusioncriteria: children and adolescents (age 6- 18 years) instead of age 6-15 years
- Interventions: removal of intervention no. 3, change of intervention no.4 into: "Start and monitoring of pharmaceutical treatment and follow-up of the treatment results, by the child psychiatrist (usual care) or GP (intervention group)"
- Design: "Non randomized controlled before-after study. Patients for the Tornado program suspected of uncomplicated ADHD are selected from the group referred patients to our outpatient-clinic in Nijmegen (n=3 treatment teams). The control-group consists of patients of seven other teams.
- Study population: children and adolescents (6-18 year-olds) with uncomplicated ADHD and their parents.
|- RECORD||14-sep-2010 - 19-sep-2014|
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