Design of a randomized controlled trial on the effects of counseling of mental health problems by occupational physicians on return to work: the CO-OP-study

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Abstract

BACKGROUND: Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.

METHODS/DESIGN: In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.

DISCUSSION: In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN34887348.

Original languageEnglish
Pages (from-to)183
JournalBMC Public Health
Volume7
DOIs
Publication statusPublished - 26 Jul 2007

Cite this

@article{6de55f69613f401784b61013c61ad642,
title = "Design of a randomized controlled trial on the effects of counseling of mental health problems by occupational physicians on return to work: the CO-OP-study",
abstract = "BACKGROUND: Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.METHODS/DESIGN: In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.DISCUSSION: In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.TRIAL REGISTRATION: Current Controlled Trials ISRCTN34887348.",
keywords = "Adult, Attitude to Health, Cost-Benefit Analysis, Counseling/economics, Female, Humans, Male, Mental Disorders/therapy, Middle Aged, Netherlands, Occupational Diseases/psychology, Occupational Medicine/standards, Outcome and Process Assessment (Health Care)/methods, Police/manpower, Practice Guidelines as Topic, Rehabilitation, Vocational, Sick Leave, Surveys and Questionnaires",
author = "Rebergen, {David S} and Bruinvels, {David J} and {van der Beek}, {Allard J} and {van Mechelen}, Willem",
year = "2007",
month = "7",
day = "26",
doi = "10.1186/1471-2458-7-183",
language = "English",
volume = "7",
pages = "183",
journal = "BMC Public Health",
issn = "1471-2458",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Design of a randomized controlled trial on the effects of counseling of mental health problems by occupational physicians on return to work

T2 - the CO-OP-study

AU - Rebergen, David S

AU - Bruinvels, David J

AU - van der Beek, Allard J

AU - van Mechelen, Willem

PY - 2007/7/26

Y1 - 2007/7/26

N2 - BACKGROUND: Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.METHODS/DESIGN: In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.DISCUSSION: In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.TRIAL REGISTRATION: Current Controlled Trials ISRCTN34887348.

AB - BACKGROUND: Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.METHODS/DESIGN: In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.DISCUSSION: In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.TRIAL REGISTRATION: Current Controlled Trials ISRCTN34887348.

KW - Adult

KW - Attitude to Health

KW - Cost-Benefit Analysis

KW - Counseling/economics

KW - Female

KW - Humans

KW - Male

KW - Mental Disorders/therapy

KW - Middle Aged

KW - Netherlands

KW - Occupational Diseases/psychology

KW - Occupational Medicine/standards

KW - Outcome and Process Assessment (Health Care)/methods

KW - Police/manpower

KW - Practice Guidelines as Topic

KW - Rehabilitation, Vocational

KW - Sick Leave

KW - Surveys and Questionnaires

U2 - 10.1186/1471-2458-7-183

DO - 10.1186/1471-2458-7-183

M3 - Article

VL - 7

SP - 183

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

ER -