|- candidate number||2695|
|- NTR Number||NTR1033|
|- Date ISRCTN created||23-aug-2007|
|- date ISRCTN requested||13-aug-2007|
|- Date Registered NTR||7-aug-2007|
|- Secondary IDs|| |
|- Public Title||DTO-FTO trial|
|- Scientific Title||Small group quality improvement on prescribing and test ordering performance of general practitioners. A large scale implementation study in the South of the Netherlands.|
|- hypothesis||This strategy will improve the number of tests ordered or the volume of prescribed drugs by 20% and decrease the interdoctor variation.|
|- Healt Condition(s) or Problem(s) studied||Implementation, Guidelines, General practitioner, Peer review, Audit|
|- Inclusion criteria||1. Groups of GP's conjoint in pharmacotherapeutic audit groups.
|- Exclusion criteria||1. Groups outside the provinces: Zeeland, Brabant or Limburg
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-feb-2010|
|- Target number of participants||50|
|- Interventions||All participating GP's receive feedback on their own test ordering and prescribing performance in the foregoing 6 months on a predefined clinical topic. The graphical comparative feedback is send to each GP individually together with an outline of current guidelines on the topic, prior to the group meeting. |
The feedback will lead to peer review, seeking and discussing explanations for differences, comparing own performance to the guidelines, discussing a plan for change and discussing barriers to change.
Each group discusses 3 clinical topics in 6 sessions. If the group whiches to do so, 2 sessions (test ordering and prescribing) can be combined into one session.
The intervention will run from september 2009 through februari 2009.
|- Primary outcome||1. The volume of ordered diagnostic tests and of prescibed medication|
2. the inter-doctor variation in both test ordering and prescribing
|- Secondary outcome||1. The quality of prescribing as defined by indicators.|
2. The level of functioning of the groups.
3. What are the costs of implementation of the strategy?
4. process data (attendance, altering of the meeting structure etc)
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| J.P. Trietsch|
|- CONTACT for SCIENTIFIC QUERIES|| J.P. Trietsch|
|- Sponsor/Initiator ||University Maastricht (UM), Department General Practitioner Medicine, University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, CZ Actief in gezondheid|
|- Brief summary||Background:|
The use of guidelines in general practice is not optimal. Inter-doctor variation in adherence to general practice guidelines is relatively high. Evidence based methods to improve adherence to guidelines and reduce inter-doctor variation are available, but not widely implemented in the Netherlands.
To improve adherence to guidelines and reduce inter-doctor variation related to test ordering and prescribing behaviour delivered by general practitioners (GPs) by audit, feedback, educational materials small peer group discussion and local opinion leaders.
1) What is the effect on GPs test ordering and prescribing behavior of a combined intervention using educational materials, audit and feedback, peer review in small groups and local opinion leaders, in a pragmatic design?
2) what are the costs of implementation of the strategy?
3) Is the gain in level of group functioning predictive of the achieved effect?
4) Do effect sizes on test ordering differ from effect sizes on prescribing?
Design of study:
A multi-center cluster randomized trial with a balanced incomplete block design.
Local GP groups and community pharmacists in the South of the Netherlands, already conjoined in pharmaco-therapeutic audit meeting (PTAM) groups. Approximately 50 groups with around 300 general practitioners will be randomly allocated to two arms. Each GP-group will be allocated to the implementation strategy, but for different topics and thus serve as blind controls.
In both arms each group chooses 2 topics from a set of 3 predefined “major” and 1 of 2 predefined “minor” clinical topics. Both arms have different balanced sets of topics they can choose from. Each member of a group will receive comparative feedback related to its own test ordering and prescribing performance on these topics. The feedback will be discussed in the group and, after discussion on the guidelines and barriers to change; working agreements have to be set. The data for the feedback is collected from existing and newly formed databases. The length of the intervention period is 18 months.
Data collected at baseline will be used to provide feedback. every 3 months the database will be fed with new data on test ordering and prescribing. These data will be used as follow-up measurement.
|- Main changes (audit trail)|
|- RECORD||7-aug-2007 - 10-okt-2008|