|- candidate number||11317|
|- NTR Number||NTR3323|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2012|
|- Secondary IDs||ERB 64 / 2011/237; NVMO / METC VUmc|
|- Public Title||Developing and evaluating live CME sessions for family physicians on cancer and heredity: An RCT.|
|- Scientific Title||Live genetic continuing medical educational meetings for general practitioners:
A double blind, randomised controlled trial of effectiveness.
|- ACRONYM||General practitioners' live genetics education evaluation: RCT|
|- hypothesis||We expect this innovative case based live genetic continuing medical educational (CME) meetings for general practitioners (GPs) to produce changes with respect to genetics and cancer skills and attitude applicable in daily family practice.|
|- Healt Condition(s) or Problem(s) studied||Cancer and genetics, Continuing educational meetings (CME), General practitioner, Simulation patients, Randomized Controlled Trial (RCT)|
|- Inclusion criteria||To be eligible for the study, Dutch GPs are required to work full- or part-time in a family practice setting. GPs are not required to comfortless use the internet, however a computer with internet access is necessary to access the online and login accessible genetic CME questionnaires.|
|- Exclusion criteria||GPs are excluded if they are unwilling or unable to participate in either randomly assigned study group.|
GPs outside the provinces of Noord Holland and Limburg in the Netherlands. The live genetic CME sessions are only held in these provinces and because we wish to not have selection bias and high validity of our testresults.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2011|
|- planned closingdate||1-mei-2012|
|- Target number of participants||66|
|- Interventions||Live accredited genetic continuing medical education (CME) meetings lasting approximately 4 hours during single evening sessions.
GPs are able to randomly sign up for the live genetic CME meetings on given dates in December/January 2011/2012 (resp. Noord Holland and Limburg, Intervention group) or March/April 2012 (resp. Noord Holland and Limburg, Control group).|
The live genetic CME incorporates multifaceted instructional approaches previously suggested (see refs.) and practice based enabling and reinforcing strategies. Content is based on previously held assessment of physician needs, genetic educational priorities and on genetic education core competences for generalists and those specializing in a field other than genetics.
|- Primary outcome||Knowledge on skills of genetics (such as how to refer and to whom) is assessed immediately before the intervention, one month after the intervention and 3 months later by mail linked to an online questionnaire.
Skills and attitude is assessed through non anonymous live simulation patient contact in general practice shortly before the intervention, one month after the intervention and 3 months later. The participants in the control groups are visited by the simulation patients at the same time, they participated in the live genetic CME after all the live visits by the simulation patients and questionnaires are done. The non anonymous simulationpatients were instructed to tell the GPs once in the practice room they are there for the project, it is therefore "semi anonymous" because of logistic reasons.
|- Secondary outcome||Participants are also one month after the intervention. 3 months later the intervention group is further assessed for applicability of the acquired knowledge in daily genetic patient care.|
|- Timepoints||Immediately before live genetic CME, 1 month after and 3 months after live genetic CME.|
|- Trial web site||http://www.emgo.nl/team/775/isahouwink/projects/|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Elisa Houwink|
|- CONTACT for SCIENTIFIC QUERIES|| Martina C. Cornel|
|- Sponsor/Initiator ||VU University Medical Center, Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Netherlands Genomics Initiative (NGI)|
|- Publications||Houwink, E. J., L. Henneman, et al. (2012). "Prioritization of future genetics education for general practitioners: a Delphi study." Genetics in medicine : official journal of the American College of Medical Genetics. Genet Med advance online publication 5 January 2012.
Houwink, E. J., S. J. van Luijk, et al. (2011). "Genetic educational needs and the role of genetics in primary care: a focus group study with multiple perspectives." BMC family practice 12: 5.
|- Brief summary||Context:|
GPs are increasingly expected to deliver genetics services in daily patient care. Education in primary care genetics is considered suboptimal and in urgent need of revision and innovation.
To determine if an innovative live genetic continuous medical education (CME) module for GPs can produce changes with respect to genetics and cancer knowledge of skills, skills and attitude in daily family practice.
Appropriately designed, evidence based live genetic CME module could result in objectively measured enhanced genetic knowledge, skills and attitude as well as continued gains 3 months after the intervention. The results from this study could inform the development of similar genetic CME, to improve FPs’ knowledge, skills and attitude in genetic patient care on other common genetic diseases with high morbidity and mortality frequently seen in primary care (such as diabetes, asthma, cardiovascular diseases).
|- Main changes (audit trail)|
|- RECORD||12-mrt-2012 - 26-apr-2012|