Economic Evaluation of Periodic Occupational Health Screening

NCT04684316 | Completed

• 1 other identifier: EZG-D7685
• Study Type: interventional
• Target: 889
• Locations: 1 country
• Sites: 4

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.

Conditions

Occupational Health; Screening; Surveys and Questionnaires

Keywords

occupational medicine; survey; periodic health surveillance

Outcome Measures

Primary Outcomes (11)

• 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

• Incidence of musculoskeletal health functioning problems

  Count of how many respondents indicated to have musculoskeletal health functioning problems

  change after 15 months

• 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

• 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

• 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

• 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

• 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

• Absenteeism

  Absenteeism in days absent using the IMTA Productivity Cost Questionnaire (iPCQ)

  change after 15 months

• 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

• Spontaneous consultations with the occupational physician

  Self-reported number of spontaneous consultations the employee had with the occupational physician

  change after 15 months

• 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 Outcomes (2)

• Health literacy

  change after 15 months

• Help-seeking behaviour

  change after 15 months

Study Arms (2)

Care-as-usual: all consult physician

NO INTERVENTION

All employees at risk are invited to attend screening. Upon arrival, several biometrics are measured (weight, length, Body Mass Index, blood pressure), along with spirometries, a vision test, and a blood and urine test. The OP then investigates the general health status and systems of the employee, which includes an anamnesis with questions about new health burdens or changes in occupational risks, follow-up questions on previous complaints, medical advice, referral to a healthcare provider, or booking another appointment with an occupational health specialist. After the PHS, a (employee-unique) link to an online questionnaire is sent by email to gather information on final (health, health care use, absenteeism and presenteeism) and intermediary (health literacy, help-seeking behaviour) outcomes.

Intervention: Electronic survey with selective consultations

EXPERIMENTAL

In the intervention group, all employees at risk receive a (employee-unique) link to an online health screening questionnaire by email. Dependent upon their answers, 20% of the employees (i.e. the 20% of the employees that mostly need contact with the OP) are referred to the occupational physician for a discussion of the results. The OP then gives medical advice, refers to a healthcare provider (e.g. general practitioner or specialist), or books a (follow-up) appointment with an occupational health specialist (OP, occupational nurse, etc.).

Other: Electronic survey with selective consultations

Interventions

Electronic survey with selective consultations OTHER

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.

Intervention: Electronic survey with selective consultations

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Belgian Association for Occupational Physicians: collaborator
• IDEWE Occupational Health Services: collaborator
• Liantis: collaborator
• Mensura: collaborator

Study Sites (4)

Heilig Hart Leuven

Leuven, Flanders, 3000, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Flanders, 9100, Belgium

Location

Heilig Hart Tienen

Tienen, Flanders, 3300, Belgium

Location

AZ Vesalius

Tongeren, Flanders, 3700, Belgium

Location

Related Publications (3)

• 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.

  PMID: 30699470 BACKGROUND

• 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.

  PMID: 26388697 BACKGROUND

• 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.

  PMID: 22276600 BACKGROUND

Study Officials

• Jonas S Steel, Msc

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are partially masked: if a participant is invited for a consultation with the occupational physician, they do not know whether this is because they are in the control group, or because they were in the intervention group and selected on the basis of their scores. Participants that do not see the occupational physician can deduce that they are part of the intervention group. Care providers, investigators, and outcomes assessors know to which group an individual pertains as this is required for the intervention.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of health economics

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)