Economic Evaluation of Periodic Occupational Health Screening

Screening Clinical Trial

Official title:

Economic Evaluation of an Online Screening Tool With Selective Follow-up Versus Periodic Health Screening by the Occupational Physician

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684316
• Other study ID #: EZG-D7685
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 889
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Occupational Health
• Screening
• Surveys and Questionnaires

Intervention

Other:
• Electronic survey with selective consultations
Participants complete an online questionnaire, after which the 20% employees that mostly need contact with the occupational physician (based on their survey score) are invited to a consultation with the occupational physician.

Locations

Country	Name	City	State
Belgium	Heilig Hart Leuven	Leuven	Flanders
Belgium	AZ Nikolaas	Sint-Niklaas	Flanders
Belgium	Heilig Hart Tienen	Tienen	Flanders
Belgium	AZ Vesalius	Tongeren	Flanders

Sponsors (5)

Lead Sponsor	Collaborator
KU Leuven	Belgian Association for Occupational Physicians, IDEWE Occupational Health Services, Liantis, Mensura

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Krogsbøll LT, Jørgensen KJ, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease. Cochrane Database Syst Rev. 2019 Jan 31;1:CD009009. doi: 10.1002/14651858.CD009009.pub3. — View Citation

Larsen AK, Holtermann A, Mortensen OS, Punnett L, Rod MH, Jørgensen 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. — View Citation

Sørensen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-perceived health	Self-perceived health using a visual analog score: 0-100 (from worst health the employee can imagine to the best health the employee can imagine)	change after 15 months
Primary	Incidence of musculoskeletal health functioning problems	Count of how many respondents indicated to have musculoskeletal health functioning problems	change after 15 months
Primary	Stress	Score that represents the risk of stress based on the Copenhagen Psychosocial Questionnaire: 0-12 (from low to high risk of stress)	change after 15 months
Primary	Burnout	Score that represents the risk of burnout based on the Copenhagen Psychosocial Questionnaire: 0-16 (from low to high risk of burnout)	change after 15 months
Primary	Sleep problems	Score that represents the risk of sleep problems based on the Copenhagen Psychosocial Questionnaire: 0-16 (from low to high risk of burnout)	change after 15 months
Primary	General mental health	Score that represents the general mental health based on the General Health Questionnaire: 0-12 (from worst to best mental health)	change after 15 months
Primary	Need for recovery after work	Score that represents the need for recovery after work, based on the Need for Recovery scale: 0-11 (from lowest to highest need for recovery after work)	change after 15 months
Primary	Absenteeism	Absenteeism in days absent using the IMTA Productivity Cost Questionnaire (iPCQ)	change after 15 months
Primary	Presenteeism	Presenteeism using the IMTA Productivity Cost Questionnaire (iPCQ), which uses a visual analog score to indicate how much work the employee could perform compared to a normal working day	change after 15 months
Primary	Spontaneous consultations with the occupational physician	Self-reported number of spontaneous consultations the employee had with the occupational physician	change after 15 months
Primary	Referrals to other health providers	Number of contact moments with other healthcare providers based on a referral by the occupational physician	change after 15 months
Secondary	Health literacy	Score representing the health literacy of the employee, based on an adapted version of the European Health Literacy Survey (EU-HLS): 0-64 (low to high health literacy)	change after 15 months
Secondary	Help-seeking behaviour	Score representing the help-seeking behaviour of the employee, based on the General Help-Seeking Questionnaire: 0-128 (high self-assessed probability of seeking help to low self-assessed probability of seeking help)	change after 15 months