Clinical trial NCT04684316: Economic Evaluation of Periodic Occupational Health Screening
Official title: Economic Evaluation of an Online Screening Tool With Selective Follow-up Versus Periodic Health Screening by the Occupational Physician
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Health
Screening
Surveys and Questionnaires
Keywords: occupational medicine
survey
periodic health surveillance
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgian Association for Occupational Physicians
name: IDEWE Occupational Health Services
name: Liantis
name: Mensura
First posted: 2020-12-24
Enrollment: 889
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Employees within the same hospital are prospectively and randomly allocated to one of two groups: an intervention group receives an electronic survey with selective follow-up by the occupational physician, and a control group where all employees undergo a periodic health screening by the occupational physician. The survey is thus used as part of the intervention, as an algorithm (based on a scoring system of the survey) which determines who should be seen by the occupational physician is evaluated. However, the survey is also used to gather data on how the selective referral affects outcomes. There are three measurement moments (each time with the same survey, and in both groups). First, baseline outcomes are measured in June 2019, after which selective follow-up in the intervention group and contact with the OP in the control group is organised in June-December 2019. Differences in outcomes between groups are then measured in February 2020, and in September 2020.
Primary purpose: SCREENING

Brief summary: In Belgium, Periodic Health Screenings (PHS) are obliged by law for several occupations, including safety functions, jobs with heightened vigilance, work that involves physical, biological or chemical agents or tasks that are an ergonomic or mental burden. Scientifically it remains an open question whether these screenings guarantee the prevention of later health problems or problems with functioning at work.

The objective of this study is to compare the cost-effectiveness of PHS with an online health screening tool with selective follow-up. In five Flemish hospitals, the employees eligible for PHS (exempting frequent exposure to ionizing radiation, preparation of cytostatics, or exposure to carcinogens, mutagens, or reprotoxic substances) are randomly assigned to a control group (receiving classical PHS at the occupational physician), or an intervention group (e-tool with selective follow-up by the physician). In the intervention group, 20% of the employees is seen by the occupational physician, based on their responses to the questionnaire. The intervention- and control group complete the questionnaire three times: before the study start (June 2019), in February 2020, and in September 2020. The study ends in March 2021.

The survey is developed as part of the study. On the one hand it contains questions for the cost-effectiveness analysis: health care use, absenteeism and presenteeism, and health literacy. On the other hand, a validated questionnaire is developed based on a systematic review of existing validated and reliable instruments, a Delphi panel of occupational physicians, and a pilot- and field study that test the reliability and validity of the survey (and its referral to the occupational physician). For the latter, the employees' health, occupational risks, work ability, and lifestyle (alcohol abuse, drug abuse, physical activity, and nutrition) are surveyed. Access to the occupational physician remains guaranteed by means of an additional question ("Do you wish to discuss the results of your survey with the occupational physician?") and as spontaneous consultations with the occupational physicians remain possible before, during, and after the trial.

The survey platform Qualtrics is used for data collection. Researchers have no insight in personal data, nor the medical files of employees, and only analyse the coded data from the surveys. Invitations for the survey are sent by the occupational physician. The coded questionnaires are saved on a KU Leuven survey, following the ISO-9001-procedure and the legal data storage period. The employer has no insight in the data. The study is performed by Jonas Steel, supervised by prof. dr. Jeroen Luyten and prof. dr. Lode Godderis, and financed by the Belgian Association for Occupational Physicians, and three external services for prevention and protection at work: IDEWE, Liantis, and Mensura.

Detailed description: In Belgium, Periodic Health Screenings (PHS) are obliged by law for several occupations and allow for early detection of health problems, advice towards risk-free behaviour, timely risk reductions or referrals to other care personnel. This makes them one of the key preventive activities of the occupational physician (OP). However, there are as of yet no strong research indications for the optimal organisation of these occupational health screenings. A recent systematic review of general health screening (not only at the workplace) did not find studies that indicated an effect (e.g. on general mortality, cardiovascular mortality, or cancer mortality), but indicated they could lead to adverse effects such as overtreatment or misplaced reassurance. Reviews in other domains such as vision screening of older drivers, tuberculosis screening of healthcare workers, tomography for lung cancer, of pre-employment investigations frequently found too few high quality studies to draw strong conclusions. There is some evidence for the effectiveness of biometric screening in reducing the number of non-communicable diseases, especially when aimed at higher risk employees or if they are combined with well-designed health programmes. However, it remains an open question whether more focused occupational screenings with risk-selection, as is the case in Belgium and the Netherlands, are beneficial.

This protocol will therefore present a study on annual periodic health screenings (PHS). In this sense, it will contribute to evidence-based decision-making for policy makers, who are currently planning to change the legislation.

A theoretically ideal experiment would compare a group of employees undergoing periodic health screening with a group without an intervention. However, three factors make the formulation of an alternative intervention necessary. Firstly, from an ethical point of view, adequate medical follow-up should be provided for all participants in the study. Secondly, current legislation requires employees to undergo screening for "risky" occupational activities to assess their aptitude for those activities. Thirdly, it is important to provide employers with an alternative form of care or follow-up, since it would not be beneficial (for any party) if employers paid the same fees to the Services for Prevention and Protection at Work (SPPW), but got less care in return. The experiment will therefore compare care-as-usual (periodic health screenings by the OP - the control group) with employees that complete an electronic health survey with selective follow-up (the intervention group). The latter encompasses that the employees' answers on the health screening tool determine whether he/she will be seen by the OP. This allows immediate data collection for the experiment, and at the same time guarantees follow-up of employees with health problems by SPPW.

The survey wants to answer to the demands (of a good PHS) of the International Labour Office by focusing on primary (sometimes secondary) prevention, by taking a risk analysis as a starting point, by allowing for both individual and collective measures, by formulating goals in advance, and because finding problems leads to adequate action. To fulfil these goals, the questionnaire will not only make use of health information (health status, early detection of occupational disease, accidents), but also of other signals that could point towards a higher risk of absence or reduced functioning: absenteeism, presenteeism, health care use, working conditions, job-specific factors, and lifestyle. In addition, the health literacy of personnel is taken into account to assess how well information about health at work (eg coming from the OP) is understood. Briefly summarized, health literacy contains three dimensions: access - how employees are able to seek and obtain health information - "understanding" - the expectations, perceived utility and interpretation of health information - and "behaviour" - the employee's intention to change behaviour as well as his behaviour itself. Finally, it is possible to measure the help-seeking behaviour of employees, to assess their tendency to seek medical care when needed. By incorporating these aspects into the survey and study, we will circumvent the complication that many preventive interventions have to face: health ameliorations and decreases in health care use, absenteeism and presenteeism only occur after several years.

Eligibility criteria: Inclusion Criteria:

* all personnel types that are eligible for periodic health screenings: personnel with safety functions, jobs with heightened vigilance, work that involves physical, biological or chemical agents or tasks that are an ergonomic or mental burden
* working age (18-70 years old)
* able to understand and answer the questionnaire in Dutch

Exclusion Criteria:

* occupational groups that perform especially risky activities (frequent exposure to ionizing radiation, preparation of cytostatics, or exposure to carcinogens, mutagens, or reprotoxic substances)

Primary outcomes:
measure: Self-perceived health
timeFrame: change after 15 months
measure: Incidence of musculoskeletal health functioning problems
timeFrame: change after 15 months
measure: Stress
timeFrame: change after 15 months
measure: Burnout
timeFrame: change after 15 months
measure: Sleep problems
timeFrame: change after 15 months
measure: General mental health
timeFrame: change after 15 months
measure: Need for recovery after work
timeFrame: change after 15 months
measure: Absenteeism
timeFrame: change after 15 months
measure: Presenteeism
timeFrame: change after 15 months
measure: Spontaneous consultations with the occupational physician
timeFrame: change after 15 months
measure: Referrals to other health providers
timeFrame: change after 15 months
Secondary outcomes:
measure: Health literacy
timeFrame: change after 15 months
measure: Help-seeking behaviour
timeFrame: change after 15 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Heilig Hart Leuven
state: Flanders
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Flanders
city: Tienen
country: Belgium
facility: Heilig Hart Tienen
state: Flanders
city: Tongeren
country: Belgium
facility: AZ Vesalius
state: Flanders
Study officials:
affiliation: KU Leuven
name: Jonas S Steel, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krogsboll LT, Jorgensen KJ, Gotzsche PC. General health checks in adults for reducing morbidity and mortality from disease. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD009009. doi: 10.1002/14651858.CD009009.pub3.
citation: Larsen AK, Holtermann A, Mortensen OS, Punnett L, Rod MH, Jorgensen MB. Organizing workplace health literacy to reduce musculoskeletal pain and consequences. BMC Nurs. 2015 Sep 17;14:46. doi: 10.1186/s12912-015-0096-4. eCollection 2015.
citation: Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H; (HLS-EU) Consortium Health Literacy Project European. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012 Jan 25;12:80. doi: 10.1186/1471-2458-12-80.