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Optimizing guideline adherence of rheumatologists


- candidate number16561
- NTR NumberNTR4449
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2014
- Secondary IDs2013/529; RR-119-protocoladherentie CCMO number; local research number Sint Maartenskliniek
- Public TitleOptimizing guideline adherence of rheumatologists
- Scientific TitleImprovement of adherence to optimal care recommendations in rheumatoid arthritis: a multimodal approach
- ACRONYMITS BETTER (IT Supported and BEhavioural Training of Tight control Enhancement in Rheumatologists)
- hypothesisIf not well treated rheumatoid arthritis (RA) can lead to severe joint damage and subsequently functional impairment. Current treatment strategies aim at quickly lowering disease activity in order to prevent later damage. RA treatment recommendations are well described in different (inter)national guidelines. But in general there is a discrepancy between available evidence regarding state-of-the-art practice and actual behaviour in daily routine. Although this is not often studied in RA it is presumed that physician adherence to RA treatment strategies is suboptimal; for example therapy is often not changed despite active disease. With this in mind, we aim to improve RA care by increasing RA guideline adherence of the clinicians working in a specialized rheumatology clinic in the Netherlands. Primary objective: 1. To assess the effects of several targeted intervention(s) on adherence to different components of optimal RA care by clinicians Secondary objectives 1. To assess which factors can modify successful guideline implementation 2. To assess user satisfaction with the newly implemented innovations 3. To assess if individual differences in adherence between clinicians exist 4. To assess if differences in adherence to the single indicators exist, and if yes a pattern can be seen
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Guideline adherence
- Inclusion criteriaClinicians: - all clinicians allowed, by Dutch law, to prescribe rheumatologic medication working at the Sint Maartenskliniek during the study period Patients: - all adult RA patients treated at the outpatient clinic of the Sint Maartenskliniek by one of the included clinicians during the study period Clinicians will be randomized, not patients.
- Exclusion criteriaClinicians: - refusal to sign informed consent Patients: - none
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-jan-2014
- planned closingdate1-jun-2014
- Target number of participants20
- InterventionsIntervention 1: education and feedback - information on RA treatment strategies including general background information and feedback on current guideline adherence (all clinicians) Intervention 2: IT support Development of a new electronic ordering and signalling system within the current electronic hospital system. (intervention group only)
- Primary outcomeIn order to assess the first study objective (effectiveness of the interventions) 13 specially developed guideline indicators will be measured for all the RA patients before and after the interventions. 1. DAS28 measurement done during the outpatient clinic visit, either by a rheumatologist or other relevant health care professional 2.X-rays of hands, feet and thorax, done at the correct moment according to the local guideline 3. Yearly assessment of functional status (Health Assessment Questionnaire) by either the rheumatologist of another health care professional 4. Prescription of conventional DMARDs and biological therapy according to the preferential order¢Ó, in case of initiation of a new DMARD or biological 5. Use or prescription of a concomitant DMARD in case of biological treatment with Adalimumab, Etanercept, Infliximab or Rituximab. 6. Therapy change in case of active disease (based on DAS28) 7. Biological dose reduction in case of stable low disease activity for ¡Ã 6 months 8. Referral to a specialized nurse within two weeks after the second outpatient clinic visit, in case of a new patient 9.Referral to or seen at the Clinimetric Centre 10. Referral to a Physician Assistant 11. Correct intervals between consecutive regular visits 12. A ¡®new patient letters¡¯ send to the general physician within two weeks after the second outpatient clinic visit 13. A ¡®control patient letters¡¯ send to the general physician within 18 months after the last letter
- Secondary outcomePossible predictive factors are derived from earlier studies done in our centre and all focus on individual clinician factors: - cognitive bias (Inventory of Cognitive Bias in Medicine; ICBM) - personality (Big Five Inventory; BFI) - thinking styles (Rational Experiental Inventory; REI) - demographics (age, gender) - work & training (years of experience as clinician, % patient contact, PhD)
- TimepointsPrimary outcome: All data needed to calculate the indicators are collected for both time periods: 6 months before the intervention (july-december 2013; retrospective) and after the intervention (january- may 2014). For every included clinician 30 patients are randomly selected. Of those patients the first visit in the measurement period was selected for data collection. Secondary outcomes: All questionnaires were used in a previous study and are therefore already completed (april 2012).
- Trial web site-
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES N. Lesuis
- CONTACT for SCIENTIFIC QUERIES A. Broeder, den
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Sint Maartenskliniek Nijmegen
- PublicationsN/A
- Brief summaryIf not well treated rheumatoid arthritis (RA) can lead to severe joint damage and subsequently functional impairment. Current treatment strategies aim at quickly lowering disease activity in order to prevent later damage. RA treatment recommendations are well described in different (inter)national guidelines. But in general there is a discrepancy between available evidence regarding state-of-the-art practice and actual behaviour in daily routine. Although this is not often studied in RA it is presumed that physician adherence to RA treatment strategies is suboptimal; for example therapy is often not changed despite active disease. With this in mind, we aim to improve RA care by increasing RA guideline adherence of the clinicians working in a specialized rheumatology clinic in the Netherlands. Therefore we developed a multimodal intervention strategy which will be tested in a randomized, controlled study. Objectives Primary objective: 1. To assess the effects of several targeted intervention(s) on adherence to different components of optimal RA care by clinicians Secondary objectives 1. To assess which factors can modify successful guideline implementation 2. To assess user satisfaction with the newly implemented innovations 3. To assess if individual differences in adherence between clinicians exist 4. To assess if differences in adherence to the single indicators exist, and if yes a pattern can be seen Methods This study will be a single centre, combined before/after and randomized controlled pilot study assessing the effect of a stepwise implementation strategy on adherence to optimal care recommendations for RA. The study is performed in a specialized clinic for orthopaedics, rehabilitation medicine and rheumatology in the eastern part of the Netherlands (Sint Maartenskliniek). The interventions will be aimed at clinicians involved in the medical treatment of RA patients (rheumatologist, rheumatology trainee, physician assistant) working at the rheumatology department of the study centre. Informed consent will be asked from the clinicians, but not from the patients as the recommendations for optimal care are already usual care. Based on the expected barriers targeted interventions will be developed, using a structured implementation model [7]. The focus of these interventions will be in the first step to 1/improve knowledge and 2/improve attitude about the recommendations and the RA guideline in general (educational session and feedback) and in the second step to 3/remove practical barriers (including changes in ordering system in the electronic patient information system). The interventions will take place in a stepwise manner, as to assess the impact on guideline adherence of the separate interventions. At the start of the study all included clinicians who have signed informed consent receive the first intervention step (knowledge and attitude). Directly afterwards the group is randomized in an intervention and control group, with the intervention group receiving intervention step two (practical barriers). In this way the effect of intervention one can be tested in an before/after controlled design and whereas intervention two is tested in a randomized controlled design. The primary outcomes of this study includes diagnostic and therapeutic behaviour of the clinicians, together forming optimal RA care (proper ordering of diagnostic tests, prescription of medication, planning of follow-up, referral to other clinicians and documentation). Adherence to the recommendations will be measured in the six months before the intervention and the four months thereafter, in order to facilitate both designs. User satisfaction with the interventions is also measured after intervention one and two, and will be taken into account when evaluating both interventions. Outcome measures & results To measure adherence to optimal RA care a set of indicators will be developed defining what optimal care is. These indicators have a dichotomous outcome (yes or no) which makes it possible to calculate a sum score per patient of all indicators scored with ¡®yes¡¯. This sum score serves as the primary outcome measure and mean sum scores will be used to judge effectiveness of the interventions. To assess modifying factors in successful implementation data from an earlier study on guideline adherence will be used. Personality, thinking styles, cognitive bias and knowledge about the (RA) guideline were measured. After every intervention it will be analysed if any of these factors modifies adherence. User satisfaction will be measured using a short questionnaire, developed specially for this study. Clinicians are encouraged to give feedback on the new system(s) as to make further improvements possible after this study.
- Main changes (audit trail)
- RECORD26-feb-2014 - 8-apr-2014


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