|- candidate number||12391|
|- NTR Number||NTR3475|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2012|
|- Secondary IDs||R 0000950 St. Radboud|
|- Public Title||Huisartsenwerk: Increasing the awareness of work and gender in primary care. |
|- Scientific Title||A cluster randomised controlled trial of a training of GPs to address work adopting a gender sensitive approach.|
|- hypothesis||Training general practitioners makes them more aware of work related problems and helps them adopt a more proactive and empowering working style when dealing with these problems.|
|- Healt Condition(s) or Problem(s) studied||Work-related disease, Presenteeism, Absenteeism|
|- Inclusion criteria||1. General practitioners working more than 0,4 full time equivalents who are expected to remain working in their present practice during the study;|
2. Patients in the age of 18 -63 working in a paid job for more than 12 hours a week.
|- Exclusion criteria||Patients with insufficient control of the Dutch language. |
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-feb-2012|
|- planned closingdate||30-sep-2013|
|- Target number of participants||32|
|- Interventions||GPs in the intervention group start with a five hour training in which lectures are mixed with interactive workshops. The following items are covered:|
The first lecture shows the relevance of the connection between work and health against the present societal changes like the aging workforce.
In a first workshop the way the participating doctors presently pay attention to work as well as ways how this practice could be improved are discussed.
The second lecture, by Dr Smit, an occupational physician (OP) deals with the rules and regulations regarding work and absenteeism, the role of the OP and ways to come to a fruitful collaboration between GPs and OPs.
In the third lecture the gender aspects of work and work related problems are illustrated by professor Lagro-Janssen who works as GP.
The fourth lecture by Dr Terluin deals with distress, ways to assess it and a good practice to empower patients and help them solve their problems themselves.
In the second workshop the participants can practice the empowerment skills they have just been taught in a role play using written cases.
The last part of the training is used for instructions regarding the data collection by the investigator.
After the data collection is started GPs are asked to fill in a form about each patient who was prepared to fill in the questionnaire. In this form they are asked for the patients occupation, whether the problem was work related, whether it interfered with their employability and whether they used the empowerment skills they had been taught during the consultation. This is considered to be a part of the intervention.
The final part of the intervention is a 3 hour booster training which takes place about two months after the initial training. It is interactive and in the first part cases of the participants are discussed with the investigator and the OP and the second part is used to try to reach consensus about a good practice.
We ask the participants to include 40 patients each, 20 of them female and 20 male, of which the first half (10 male and 10 female) is to be included before the booster training and the second half after the booster training.
The control group is asked to deliver care as usual. As it could be surmised that their usual care could be influenced by the data collection we try to make sure that the data collection in the control group practices is done as much as possible by the receptionists who are trained by the investigator during visits of the practices.
|- Primary outcome||RTW-SE scale: A scale developed to measure the extent to which a worker feels he/she is able to cope with the challenges of his/her job. It ranges between 10 and 60 and has been shown to reliably predict return to work in other populations.
Attention paid by GPs to work related issues as perceived by the worker patients that consulted them. This attention will be operationalised in the following way:
For each GP the following five proportions will be calculated:
1. The proportion in which he/she knows what job the patient has;
2. The proportion in which a possible relation between their health problem and their job was discussed;
3. The proportion in which their GP had asked whether their presented health problem made it impossible for them to go to work;
4. The proportion in which an advice to stop or resume work was given;
5. The proportion in which their GP had helped them self find a solution for their problems (i.e. had been empowering them).
Registration of work and workrelated problems by GPs will be measured by counting the entries of jobs in the computer system, the use of the codes for work related problems (ICPC Z05 and Z05.01 to Z05.05).
|- Secondary outcome||A deeper understanding of the expectations of patients regarding their GPs role with respect to work related problems.|
A better insight in the facilitators and hindrances that lead to attention being paid to work and work related problems.
Insight in the satisfaction of both patients and general practitioners with the proposed working style.
|- Timepoints||16-02-2012: Training |
26-04-2012 and 14-05-2012: Booster training
30-06-2012: End of patient inclusion
30-09-2013: Last inquiry
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C.A. Kock, de|
|- CONTACT for SCIENTIFIC QUERIES|| C.A. Kock, de|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|- Brief summary||Clusterrandomised controlled trial to investigate whether GPs can be trained to adopt a more proactive approach of work related problems, taking gender into consideration. They also learn to adopt an empowering working style which helps their patients find their own solution for work related problems. One group of 16 GPs is trained while another group goes on delivering usual care. Of each GP we aim to include 40 patients, 20 of them female and 20 male. |
|- Main changes (audit trail)||Changes to methods after trial commencement (3b)
Initially, the inclusion of patients willing to participate turned out to be a challenge for many of the participating practices. After the main problems had been solved, the rate it which patients were included remained slower than expected. Therefore we extended the inclusion period to 11 months, after which enough patients had consented to participate. To minimize the Lasagna effect, the task of inviting patients to complete questionnaires T2 and T3 was taken over from the practice assistants by members of the research team.(8) Moreover, as we were especially interested in the long term effects of the intervention, all patients of whom addresses were available were invited to complete the third questionnaire, even if they had not completed questionnaires at T1 or T2.
|- RECORD||18-mei-2012 - 16-sep-2016|