Skip to main content

Effectiveness of a screening tool to assess prevention and rehabilitation needs of 45 to 59 years old in primary care – study protocol of a pragmatic randomized controlled trial (PReHa45)



For years it has been stated that the need for prevention and rehabilitation is not always identified early enough. Although many individuals have regular contact with a general practitioner (GP), this access path for applying for a prevention or rehabilitation service has not been fully exploited. The important role of GPs in supporting the intention to apply is highlighted in the research. This study aims to evaluate the effectiveness of the “check-up 45 + ” to support GPs both in identifying the need for prevention and rehabilitation services and in submitting applications.


The study is designed as a two-arm, pragmatic 1:1 randomised controlled study (RCT), which will be conducted in about 20 general practices in the German states of Berlin and Brandenburg. Patients (n = 1,654) aged from 45 to 59 years will be recruited by medical assistants. In addition to usual care, both study groups will receive a questionnaire covering socio-economic and occupational variables to be filled out immediately in the waiting room. The intervention group passes through the “check-up 45 + ”. This includes the completion of the “screening 45 + ” that aims to assess the need for prevention and rehabilitation services. Medical assistants will immediately evaluate this 2-page screening tool. If a need is identified and confirmed by the GP, information and application documents will be handed over. Moreover, the application process for rehabilitation services is simplified.

Primary outcome is the proportion of applications for prevention or rehabilitation services financed by the German Pension Insurance. Administrative data will be provided for this purpose. Secondary outcomes include the proportion of approved applications and completed services. In addition, the proportion of persons with a need for prevention or rehabilitation according to the “check-up 45 + ” will be examined. Semi-structured interviews will be conducted and content-analysed to determine the practicability and acceptance of the “check-up 45 + ” by the relevant stakeholders.


Prevention and rehabilitation need is insufficiently identified and addressed so far. This study will determine the effectiveness of the “check-up 45 + ” in primary care.

Trial registration

German Clinical Trials Register (DRKS00028303, 03.03.2022).

Peer Review reports


Maintaining employability

Due to later retirement age and the increasing lack of qualified personnel, the importance of maintaining or restoring the work ability of older employees is increasing [1, 2]. In order to prevent a reduction in work ability at an early stage and to simplify access to prevention and rehabilitation services, the principle of "prevention before rehabilitation before pension" must be strengthened. In fact, half of those who receive a disability pension for the first time have not received any medical rehabilitation or other services offered by the German Pension Insurance to enhance work ability [3,4,5,6]. If a disability pension is granted, employees are very unlikely to return to work [7].

Needs, application procedure and barriers

A central function of the German Pension Insurance is to promote and maintain the work ability of insured persons by financing rehabilitation measures in specialized rehabilitation facilities with a usual duration of three to four weeks. Furthermore, the German Pension Insurance is to provide prevention services for insured persons with initial health impairments. These prevention services include about three to five full-time days in specialized health care provision (usually rehabilitation facilities) and three to six months extra-occupational group services. Both prevention and rehabilitation services require an application by the insured person to the German Pension Insurance. The prevention application can be filled out online by the patient in a few minutes. The application for rehabilitation is more time-consuming and includes extensive application documents that must be filled out by the patient and physician. Within the study, the application procedure will be simplified by providing the necessary forms, reducing the number of forms required and replacing the doctor’s medical report with a short form.

The German Federal law to strengthen prevention and rehabilitation in working life (Flexirentengesetz) provides, according to § 14 (3) of the Social Security Code VI, that for insured persons aged 45 and over, the "introduction of voluntary, individual, work-related health care for insured persons […] is to be tested in model projects". The study presented here is based on this law and is one of about ten model projects in Germany. In addition, the German Federal law to strengthen the participation and self-determination of persons with disabilities (Bundesteilhabegesetz) provides that the need for rehabilitation of insured persons is to be recognized at an early stage by the rehabilitation providers using appropriate instruments. So far, there is no active screening to identify a possible need for prevention or rehabilitation. For years, it has been stated that prevention and rehabilitation needs have not always been identified in time and that rehabilitation services should be applied earlier to prevent or mitigate the progression of chronic diseases and disabilities. The application behaviour differs from the subjective and objective need for medical rehabilitation. It is assumed that the need is significantly higher than the number of applications [8,9,10,11]. Challenges and barriers for applying are reported both by patients and physicians [12]. In addition to personal, familial, or professional reasons, patients' lack of knowledge about the application process is an obstacle [13,14,15]. Patients have a great need for support and information on how to apply [9, 13, 14]. Likewise, physicians report information deficits regarding the need for and application of rehabilitation services, and non-transparent refusal criteria [16,17,18]. There is a need to systematically identify prevention and rehabilitation needs, proactively inform insured persons about services and remove barriers to accessing medical rehabilitation [4, 19].

Evaluation of the “check-up 45 +” in primary care

Access through the GP practice to apply for prevention or rehabilitation services is still under-used [17, 20, 21]. The important role of GP support as a determinant of intention to apply is highlighted in the research [10, 12, 22,23,24]. 74% of respondents name their general practitioner or specialist as the "first point of contact for obtaining information" if there is a need for medical rehabilitation [25]. Therefore, it seems useful to improve GPs' ability to recognize the need for prevention and rehabilitation and to facilitate the application process [20, 21, 23, 26].

A range of studies developed and evaluated screening instruments for needs assessment [20, 27-35]. The German Pension Insurance evaluates different approaches in various settings to identify prevention and rehabilitation needs within the framework of the so-called "check-up 45 + " in several model projects. The aim is to establish routine screening approaches nationwide to recognize work-related disability at an early stage, to offer the necessary prevention or rehabilitation services, and to maintain health and employability [36]. In this study, primary care in GP practices is the place where a screening for prevention and rehabilitation needs based on the so-called "screening 45 + " is applied [37]. The "screening 45 + " assesses the five dimensions work ability, mental well-being, functional ability, coping behaviour, and physical activity.

The following research question will be explored: can the number of applications for prevention and rehabilitation services be increased through the “check-up 45 + ” in GP practices?


The aim of this study is to evaluate the effectiveness of the "check-up 45 + ". We will examine whether the "check-up 45 + " affects the number of applications for German Pension Insurance services through an early identification of needs of patients in primary care by a structured needs assessment, provision of information about German Pension Insurance services and a simplified application procedure.

In addition, the practicability and acceptance of the implementation of the “check-up 45 + ” will be assessed among the stakeholders involved.

Trial design

The “PReHa45” study is a two-arm, pragmatic, 1:1 randomised controlled intervention study (RCT). In GP practices in the German states of Berlin and Brandenburg, patients aged 45–59 years are randomly assigned to an intervention or control group by the practice staff. The intervention group undergoes the "check-up 45 + " in addition to usual care in GP practices, while the control group only receives usual care and completes a general questionnaire on socio-economic and occupational characteristics. The primary criterion for assessing the effectiveness of the "check-up 45 + " is the proportion of applications for prevention and rehabilitation services, determined by administrative data from the individual pension insurance account of the study participants. Practicability, acceptance, and satisfaction with the "check-up 45 + " are examined with semi-structured interviews. The GP practices receive financial compensation for each participant, depending on the effort required. Table 1 shows that according to the nine domains of the PRECIS-2 tool the RCT has a pragmatic approach [38].

Table 1 PRECIS-2 domain (1 = very explanatory, 5 = very pragmatic)

The study protocol is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow diagram (Fig. 1) and checklist (Additional File 1) [39].

Fig. 1
figure 1

SPIRIT flow diagram of the study


Study setting

The intervention is implemented in about 20 GP practices located in Berlin and Brandenburg. Practices in rural and urban areas, each with differing social structures, participate. The practices can have different specialisations (e.g. occupational medicine, naturopathy), but are all maintained by general practitioners or internists practising general medicine. In most practices, one physician and two medical assistants conduct the study; in some practices more persons are involved.

Eligibility criteria

All patients aged between 45 and 59 years and insured by the German Pension Insurance Berlin-Brandenburg or the German Federal Pension Insurance can participate in the study. Further inclusion criteria are residence in Berlin or Brandenburg, contribution to social insurance for at least 6 months within the last 24 months and sufficient knowledge of German. Excluded are patients who are currently applying for or receiving a prevention or rehabilitation service from the German Pension Insurance as well as those who receive a disability or old-age pension.



Participants in the intervention group undergo the “check-up 45 + ”, which includes the completion of the "screening 45 + ". This two-page questionnaire is an assessment to identify existing prevention and rehabilitation needs and measures the five dimensions of work ability, mental well-being, functional ability, coping behaviour and physical activity. These dimensions contain partly adapted questions from established instruments that have been evaluated as useful in practice to predict a risk of work disability or to identify existing limitations in the work ability [37]. It will be handed out with an additional two-page questionnaire covering socio-economic and occupational variables by the practice staff, to be filled out in the waiting room. Immediately afterwards, the "screening 45 + " is evaluated by the practice staff by calculating dimension-specific sum scores and applying predefined thresholds in order to assess a potential prevention or rehabilitation need. Each dimension has a value range from 0 to 12. Depending on the score, there are three possible recommendations: (1) no need for a prevention or rehabilitation service, (2) need for a prevention service, and (3) need for a rehabilitation service, as presented in Table 2. If the practice does not agree with the result (e.g. because of its own previous experience with the patient), the practice is free not to follow the screenings-based recommendation and to give another of the three possible recommendations. Based on the final decision, the following further steps of the “check-up 45 + ” result:

Table 2 Evaluation of the "screening 45 + "

(1) If no need for a German Pension Insurance service has been defined, the patient receives a written overview about the result of the "check-up 45 + ". No information material or application forms for German Pension Insurance services are handed out. In case of a high sum score in dimension D or E, the patient may be advised to consider individual health measures. (2) If a need for a prevention service has been defined, the patient receives information material for the prevention services of the German Pension Insurance (RV Fit and DO IT YOURSELF / ONLINE). If desired the patient may apply autonomously for a prevention service. (3) If a rehabilitation service has been defined, patients are supported and guided in the application procedure by the practice staff. They receive information material and all necessary rehabilitation application forms as well as an extract of pre-existing relevant medical findings. The application process is also facilitated for physicians, who do not have to submit the usual medical report form of the German Pension Insurance.


The control group is recruited in the same way as the intervention group but is only handed a two-page questionnaire covering socio-economic and occupational variables.

Outcomes and other measures

Primary and secondary outcomes are recorded using the administrative data (individual pension insurance accounts) from the German Pension Insurance Berlin-Brandenburg and German Federal Pension Insurance and the “screening 45 + ”. A complete list of all measured constructs, sources, value range and scaling is presented in Table 3.

Table 3 Source and reference, total score and scaling in the randomized controlled trial

Primary outcome

The primary outcome is the proportion of applications for prevention and rehabilitation services of the German Pension Insurance within two months after study participation of each patient.

Secondary outcomes

Secondary outcomes are (1) the proportion of approved applications for prevention interventions and medical rehabilitation services and (2) the proportion of completed prevention interventions and medical rehabilitation services. In addition, (3) the proportion of persons with a need for prevention and rehabilitation according to the "check-up 45 + " is examined (intervention group only). (4) The practicability, acceptance of and satisfaction with the implementation of the "check-up 45 + " under everyday conditions among participating patients, practice staff and employees of the German Pension Insurance involved in the study will be assessed by semi-structured interviews.

Other measurements

Health-related and sociodemographic characteristics are assessed via the patient questionnaires and administrative data from the individual pension insurance account. Both groups receive a two-page questionnaire. These variables are collected for sample description, group comparison and to identify relevant covariates related to application for prevention or rehabilitation services. The intervention group additionally completes the two-page”screening 45 + ”.

“Screening 45 + ”

Dimension A—work ability

Work ability is assessed by adapted questions from the "Screening Instrument to Assess the Need for Medically and Occupationally Oriented Measures" (SIMBO) and the "Work Ability Index" (WAI). The SIMBO has already been used in numerous studies [40, 48]. The question on sick leave in the past 12 months with the 5-point scale (0 "not at all" to 4 "more than 6 months") and on the expected future work ability with a 4-point scale (0 "no severe health impairment" to 3 "no longer working at all") were included in a modified form. The WAI is a questionnaire that can provide conclusions about employees' ability to work in relation to their individual conditions and the underlying working conditions [41, 49, 50]. In the "screening 45 + ", the question on the self-rated work ability was adapted with a 6-point scale (0 "no impairment" to 5 "can no longer work at all").

Dimension B—mental well-being

Mental well-being is assessed via the short form of the Patient Health Questionnaire-4 (PHQ-4). The PHQ-4 is an ultra-short screening instrument with four items to identify depressive and anxiety symptoms [42]. The items are rated on a 4-point scale from 0 ("not at all") to 3 ("almost every day"). The PHQ-4 is included in the "screening 45 + " in an unmodified form.

Dimension C—functional ability

Functional ability is assessed via adapted questions from the generic questionnaire "Indicators of Rehab Status, Version 3" (IRES-3) [43]. Four items were selected from the original scale. In comparison to the original version, the 5-point Likert scale was reduced to four levels for reasons of comparability with the items of the other dimensions. The central answer category was deleted. The level of activity can be documented from 0 ("no problem") to 3 ("impossible").

Dimension D—coping behaviour

The German Pension Insurance developed its own instrument consisting of four items to assess coping behaviour [37]. Coping is measured in different domains on a 4-point Likert scale (0 "very good" to 3 "not at all").

Dimension E—physical activity

The items on physical activity are adapted from the National Health Service's “German Practice Physical Activity Questionnaire” (GPPAQ). The GPPAQ is a short self-report questionnaire that can be used to measure physical performance [44, 51]. Four items were selected for the "screening 45 + " and translated into German. In each case, the amount of time activity per week is recorded in different areas with four gradations from 0 ("2 h or more") to 3 ("not at all").

Short questionnaire and administrative data

Subjective health status

The subjective health status is assessed, according to a recommendation of the World Health Organization (WHO) [52]. There are five answer options from 0 ("very good") to 4 ("very poor"). This item is part of the Minimum European Health Module (MEHM) [45] and is applied in GEDA – German Health Update [53].

Previous use of rehabilitation services

The previous use of rehabilitation services may influence application behaviour [54]; therefore the questionnaire asks whether a rehabilitation has already been carried out.

Further measurements of work ability

In the short questionnaire the current work ability compared with the lifetime best is measured by the “Work Ability Score” (WAS) [46], the first item from the WAI. The 11-point scale ranges from 0 ("completely unable to work") to 10 ("maximum ability to work"). The subjective prognosis of work ability is assessed with the SPE scale ("subjective prognosis of employability") [27]. Considering the current state of health and work ability, the survey determines whether the current occupation can be carried out until retirement age (0 “sure” to 4 “definitely not”), whether the general work ability is permanently at risk and whether the person is currently considering applying for a disability pension.

Work-related data

The German Pension Insurance provides information on voluntary contributions on days with creditable periods due to unemployment in months and the occupational status.

Sociodemographic data

Further data regarding gender, age, educational and professional qualifications, subjective socio-economic status as well as primary language spoken in the household will be assessed via the short questionnaire.

Sample size estimation

The calculation of the sample size is based on a research project that evaluated the psychometric properties, reliability and criterion validity of the “screening 45 + ” [37]. This study revealed a prevalence of 15.8% in total of persons needing prevention or rehabilitation services among insured persons of the German Pension Insurance aged 45 to 60 (n = 4,903): 13.0% showed a need for a prevention service and 2.8% a need for a rehabilitation service. Only a few of the persons with a need for prevention or rehabilitation services intend to submit an application. Moog et al. [11] estimate this proportion at 20%. Thus, we expect 3.2% of the participants in the intervention group to apply for a prevention or rehabilitation service after participation in the "check-up 45 + ". We assume an association between the "check-up 45 + " and the application for a German Pension Insurance service if this takes place within 2 months. For the control group, we calculated the proportion based on the statistics from the German Pension Insurance [55]. Consequently, the proportion of insured persons aged 45 to 59 who submit an application for prevention or medical rehabilitation services within two months is estimated at 0.73%.

In order to detect a difference between the intervention and the control group of applications for prevention and medical rehabilitation services, the power calculation (two-sided test, type I error rate: 5%, power: 85%) resulted in a required minimum sample size of n = 661 per group. We assume that a proportion of participants cannot be included into the analyses because they do not meet the inclusion criteria. Some inclusion criteria are difficult for the practice staff to verify when recruiting participants, e.g. insurance status. To take into account a possible drop-out rate of 20%, the targeted sample size is increased to n = 827 per group. The Consolidated Standards of Reporting Trials (CONSORT) [56] flow diagram is presented in Fig. 2.

Fig. 2
figure 2

CONSORT flow diagram of the study


Before the recruitment phase, the study team visits the GP practices for an one-hour training session on the procedure of the study. The practice staff invite patients who visit the practice for standard care and meet the inclusion criteria (age, insured status) to participate in the study. Study information, consent form and questionnaires are handed out in envelopes for completion. To avoid selection bias, the practice staff is encouraged to address patients who fulfil the inclusion criteria, regardless of their health status and known need for rehabilitation. They should be approached in a neutral way without receiving information about potential prevention or rehabilitation services.


Block randomisation will be performed for each general practice, with the same number of patients per block. Allocation to the intervention or control group is randomised within each block (10 blocks of 10 per practice) to keep the number of case IDs balanced, even if the lists are not finished. The case IDs were generated with R version 4.2.2 and are reproducible. Only the German Pension Insurance is able to link the pseudonyms to the actual persons.

The assignment of the participants included in the study to the intervention or control group is performed randomly, as the practice staff cannot influence the group affiliation of the invited participants during the recruitment process. The practice staff hand out the questionnaires and study documents in sealed, non-transparent envelopes on which the group affiliation is not indicated. The envelopes are only labelled with the questionnaire number (case ID) and are first opened by the participants.


The practice staff are blinded during the recruitment process while inviting patients to the study. Once patients return the completed questionnaires, the practice staff are no longer blinded.

The patients are not aware of their group assignment, as they have no knowledge of the existence of two groups. Unblinding the control group is not intended. Participants in the intervention group are aware of the intervention when they are informed about the result of the "check-up 45 + " after evaluation of the "screening 45 + ". The project coordinators at the German Pension Insurance have no knowledge of the group assignment. The Charité study staff who perform the analyses know the group assignment.

Data collection

Primary and secondary outcomes are provided by the German Pension Insurance registers and the questionnaire “screening 45 + ” (Tab. 3). Administrative data can be collected reliably and validly for both groups. The German Pension Insurance transmits these data electronically, encrypted and pseudonymised. This enables a complete recording of the administrative data of all study participants. The data collection by patient questionnaires takes place in the GP practices. The study procedure and the questionnaires were tested and adapted in advance in a pre-test with two practices. The practices start at staggered intervals and aim to recruit about 80 participants per practice. Completed questionnaires are stored in the GP practices. During recruitment, Charité study staff regularly visit GP practices to monitor procedures and collect patient questionnaires. Consent forms and study list are sent by the practices to the German Pension Insurance. If participants withdraw their consent, their collected data will be deleted.

After recruitment is completed, semi-structured interviews will be conducted by telephone or in person to investigate practicability and acceptance of the “check-up 45 + ”. Practice staff, participating patients and employees of the German Pension Insurance involved in the study will be interviewed. The interviews are recorded, transcribed, and analysed anonymously.

Data management

A detailed data protection concept was developed with the data protection officer of the German Pension Insurance Berlin-Brandenburg, which clarifies the rights of participants as well as the organisational procedures for the collection, processing and storage of data. Pseudonymised administrative data of the participants are transferred from the German Pension Insurance Berlin-Brandenburg and German Federal Pension Insurance to the Charité based on the unique case ID for evaluation after completion of the recruitment process.

Collected questionnaires are scanned and verified at the Charité with the data capture system evasys, to assign the pseudonymised questionnaire data to the corresponding case ID and to export them for the analyses. Data entry and data verification are carried out by trained research assistants. The questionnaires and administrative data can be linked via the unique case ID. The electronic data are stored on an internal server of the Charité. Only the study team has access to the data.

Statistical analysis

All analyses are conducted according to the intention-to-treat principle. Both descriptive and analytical statistics will be used to compare differences between the two study groups. In order to determine the comparability of the two study groups, the distribution of the socio-demographic and health-related variables will be described. Frequencies, means and standard deviations will be calculated according to the scale level. For non-normally distributed data, medians and interquartile ranges will be presented. For the primary and secondary outcomes, absolute and relative frequencies and their 95% confidence intervals will be reported for both study groups. Fisher’s exact test will be applied to test for statistical significance between the intervention and control group. The results will be regarded as significant if the p-value is less than 0.05 (two-sided). Exploratory subgroup analyses will be performed in order to describe differences stratified by gender, age, GP practices and other possible confounders.

The qualitative interview data will be analysed according to the Kuckartz method of qualitative analysis [57].


Needs assessment, information about and claiming of prevention and rehabilitation services to maintain work ability must take place earlier. Many studies are examining interventions to address patients with a prevention or rehabilitation need at an earlier stage. Our study uses a pragmatic approach to investigate the effectiveness and acceptance of a screening tool to assess prevention and rehabilitation needs in primary care. The aim is to examine whether the "check-up 45 + " affects the proportion of applications for German Pension Insurance services through an early identification of needs of patients by a structured needs assessment, by providing information about German Pension Insurance services and a simplified application procedure.

The authors of this protocol will write the final study publications. The use of professional writers is not intended. The findings of our study will be published in articles, conference presentations and in a final report. The study protocol was developed in accordance to the protocol template of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) [39].

Trial status

Recruitment has started and is currently ongoing.

Availability of data and materials

Primary data previously used for publications can be made available to researchers in anonymised form at the individual level after a justified and methodologically appropriate request to in accordance with data protection regulations for answering the questions formulated in the request. In accordance with data protection regulations, the study data will be retained for a maximum of 10 years after the end of the study.



German Health Update


German Pension Insurance


General Practitioner


General Practice Physical Activity Questionnaire


Indicator of Rehab Status, Version 3


Minimum European Health Module


Patient Health Questionnaire


Screening Instrument to Assess the Need for Medically and Occupationally Oriented Measures


Subjective prognosis of employability


Work Ability Index


Work Ability Score


World Health Organization


  1. Feißel A, Swart E, March S. Health of older workers. Results of the baseline survey from the lidA study. Zentralbl Arbeitsmed Arbeitsschutz Ergon. 2016;66(3):129–36.

    Article  Google Scholar 

  2. Hasselhorn HM, Ebener M. Die differenzierte Rolle von Gesundheit für die Erwerbsteilhabe im höheren Erwerbsalter – eine Diskussion anhand des „lidA-Denkmodells zu Arbeit, Alter und Erwerbsteilhabe“. In: Hohnerlein E, Hennion S, Kaufmann O, editors. Erwerbsverlauf und sozialer Schutz in Europa. Berlin, Heidelberg: Springer; 2018. p. 215–23.

    Chapter  Google Scholar 

  3. Mittag O, Reese C, Meffert C. (Keine) Reha vor Rente: Analyse der Zugänge zur Erwerbsminderungsrente 2005–2009. WSI-Mitteilungen. 2014;67(2):149–55.

    Article  Google Scholar 

  4. Roski C, Romppel M, Grande G. Risk factors for disability pensioning caused by mental disorders - a systematic review. Gesundheitswesen. 2017;79(6):472–83.

    CAS  PubMed  Google Scholar 

  5. Bethge M, Spanier K, Köhn S, Schlumbohm A. Self-reported work ability predicts health-related exit and absence from work, work participation, and death: longitudinal findings from a sample of German employees. Int Arch Occup Environ Health. 2021;94(4):591–9.

    Article  PubMed  Google Scholar 

  6. Fauser D, Zimmer J-M, Golla A, Schmitt N, Mau W, Bethge M. Self-reported prognosis of employability as an indicator of need for rehabilitation: a cohort study in people with back pain. Rehabilitation. 2022;61(2):88–96.

    Article  PubMed  Google Scholar 

  7. Köckerling E, Sauzet O, Hesse B, Körner M, Razum O. Return to work after temporary disability pension. Gesundheitswesen. 2020;82(11):894–900.

    PubMed  Google Scholar 

  8. Raspe H. Need for rehabilitation services: theoretical considerations in “needs assessment.” Rehabilitation. 2007;46(1):3–8.

    Article  CAS  PubMed  Google Scholar 

  9. Hesse B, Heuer J, Gebauer E. Rehabilitation in the view of small and midsized enterprises: knowledge, appreciation and possibilities to cooperate - results of the KoRB-project. Rehabilitation. 2008;47(6):324–33.

    Article  CAS  PubMed  Google Scholar 

  10. Bethge M, Peters E, Michel E, Radoschewski FM, Spanier K. Motivational and volitional determinants of applying for psychosomatic rehabilitation: findings of a cohort study. Rehabilitation. 2016;55(6):341–7.

    CAS  PubMed  Google Scholar 

  11. Moog S, Mohr S, Weiß J, Knittel T, Klein R, Madday C. Analyse des Antragsrückgangs bei Leistungen zur medizinischen Rehabilitation, Endbericht. Freiburg/Düsseldorf: Prognos AG; 2019.

  12. Schmitt N, Fauser D, Golla A, Zimmer J-M, Bethge M, Mau W. Determinants of the wish for rehabilitation and the intention to apply in persons with back pain. Rehabilitation. 2020;60(3):185–94.

    PubMed  Google Scholar 

  13. Walther AL, Falk J, Deck R. Need for information about medical rehabilitation of persons with German Pension Insurance: a written survey. Gesundheitswesen. 2018;80(7):635–41.

    PubMed  Google Scholar 

  14. Zimmer J-M, Fauser D, Golla A, Wienke A, Schmitt N, Bethge M, et al. Barriers to applying for medical rehabilitation: a time-to-event analysis of employees with severe back pain in Germany. J Rehabil Med. 2022;54:jrm00274.

    Article  PubMed  Google Scholar 

  15. Golla A, Richter C, Mau W, Saal S. Factors influencing the access to and utilization of medical rehabilitation services recommended after care assessment – results of qualitative interviews with professionals involved in the decision process. Rehabilitation. 2021;61(1):25–33.

    Article  PubMed  Google Scholar 

  16. Fröhlich S, Niemeyer R, Greitemann B. Kenntnisse, Bewertungen und Informationsbedarf zum thema rehabilitation: quantitative Ergebnisse einer Befragung von Hausärzten/innen und Orthopäden/innen in Westfalen-Lippe. DRV Schriften. 2018;117:89–92.

    Google Scholar 

  17. Walther A, Pohontsch N, Deck R. Need for information concerning medical rehabilitation of the federal german pension fund - findings of an online survey of general practitioners. Gesundheitswesen. 2014;77(5):362–7.

    PubMed  Google Scholar 

  18. Schubert M, Fiala K, Grundke S, Parthier K, Behrens J, Klement A, et al. Access to medical rehabilitation from the viewpoint of practitioners – problems and opportunities for improvement. Z Physiother. 2012;22(5):264–70.

    Google Scholar 

  19. Buschmann-Steinhage R. Trends in medical rehabilitation: supply structure and target groups. Bundesgesundheitsbl. 2017;60(4):368–77.

    Article  Google Scholar 

  20. Deck R, Träder JM, Raspe H. Identification of potential need for medical rehabilitation by general practitioners: idea and reality. Rehabilitation. 2009;48(2):73–83.

    Article  CAS  PubMed  Google Scholar 

  21. Pohontsch N, Träder JM, Scherer M, Deck R. Recommendations for overcoming interface problems in medical rehabilitation of federal pension funds and statutory health insurance. Rehabilitation. 2013;52(5):322–8.

    CAS  PubMed  Google Scholar 

  22. Sylvain C, Durand M-J, Maillette P, Lamothe L. How do general practitioners contribute to preventing long-term work disability of their patients suffering from depressive disorders? A qualitative study. BMC Fam Pract. 2016;17(1):1–11.

    Article  Google Scholar 

  23. Muschalla B, Linden M. Indication for inpatient psychosomatic rehabilitation in primary care patients with chronic mental disorders and participation impairments. Rehabilitation. 2019;58(6):376–84.

    PubMed  Google Scholar 

  24. Fauser D, Schmitt N, Golla A, Zimmer J-M, Mau W, Bethge M. Employability and intention to apply for rehabilitation in people with back pain: a cross-sectional cohort study. J Rehabil Med. 2020;52(11):1–9.

    Article  Google Scholar 

  25. Golla A, Saal S, Meyer G, Mikolajczyk R, Mau W. Subjektive Informiertheit zur medizinischen Rehabilitation – Ergebnisse einer bevölkerungsbasierten online-Befragung. DRV-Schriften. 2021;123:207–9.

    Google Scholar 

  26. Fuchs S, Parthier K, Wienke A, Mau W, Klement A. Fostering needs assessment and access to medical rehabilitation for patients with chronic disease and endangered work ability: protocol of a multilevel evaluation on the effectiveness and efficacy of a CME intervention for general practitioners. J Occup Med Toxicol. 2017;12(1):1–8.

    Article  Google Scholar 

  27. Mittag O, Meyer T, Glaser-Möller N, Matthis C, Raspe H. Predicting gainful employment in a population sample of 4225 statutory pension insurance members covering a prognostic period of five years using a brief subjective prognostic employment scale (SPE Scale). Gesundheitswesen. 2006;68(5):294–302.

    Article  CAS  PubMed  Google Scholar 

  28. Gerdes N, Karl EL, Jäckel WH. Computer aided support for deciding on applications for rehabilitation (“CEBRA”). Rehabilitation. 2007;46(1):16–23.

    Article  CAS  PubMed  Google Scholar 

  29. Holmgren K, Hensing G, Bültmann U, Hadzibajramovic E, Larsson M. Does early identification of work-related stress, combined with feedback at GP-consultation, prevent sick leave in the following 12 months? a randomized controlled trial in primary health care. BMC Public Health. 2019;19(1):1–10.

    Article  Google Scholar 

  30. van Beurden KM, Brouwers EP, Joosen MC, Terluin B, van der Klink JJ, van Weeghel J. Effectiveness of guideline-based care by occupational physicians on the return-to-work of workers with common mental disorders: design of a cluster-randomised controlled trial. BMC Public Health. 2013;13(1):1–8.

    Google Scholar 

  31. Arends I, van der Klink JJ, van Rhenen W, de Boer MR, Bültmann U. Prevention of recurrent sickness absence in workers with common mental disorders: results of a cluster-randomised controlled trial. Occup Environ Med. 2014;71(1):21–9.

    Article  PubMed  Google Scholar 

  32. Kant I, Jansen NW, Van Amelsvoort LG, Van Leusden R, Berkouwer A. Structured early consultation with the occupational physician reduces sickness absence among office workers at high risk for long-term sickness absence: a randomized controlled trial. J Occup Rehabil. 2008;18(1):79–86.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Østerås N, Gulbrandsen P, Benth JŠ, Hofoss D, Brage S. Implementing structured functional assessments in general practice for persons with long-term sick leave: a cluster randomised controlled trial. BMC Fam Pract. 2009;10(1):1–9.

    Article  Google Scholar 

  34. Holmgren K, Fjällström-Lundgren M, Hensing G. Early identification of work-related stress predicted sickness absence in employed women with musculoskeletal or mental disorders: a prospective, longitudinal study in a primary health care setting. Disabil Rehabil. 2013;35(5):418–26.

    Article  PubMed  Google Scholar 

  35. Schlöffel M, Kampling H, Fichtner U, Farin-Glattacker E, Pollmann H, Mittag O. Online Rehab-Need Test (OREST): effectiveness of an invitation to Proactive ccreening (self-test) for the need for medical rehabilitation among individuals covered by the german statutory pension insurance agencies in Baden-Württemberg and the rhine region. Rehabilitation. 2021;60(4):243–51.

    PubMed  Google Scholar 

  36. Bitzer E, Flaig S. Screening for and prevention of early retirement. Public Health Forum. 2020;28(2):103–6.

    Article  Google Scholar 

  37. Brünger M, Bernert S, Graf A, Spyra K. Validierung eines Fragebogens zur Erfassung des Rehabilitations- und Präventionsbedarfs von Über-45-Jährigen (Ü45-Screening II). Abschlussbericht (1.0). Zenodo. 2021.

  38. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.

    Article  PubMed  Google Scholar 

  39. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346: e7586.

    Article  PubMed  PubMed Central  Google Scholar 

  40. Streibelt M, Bethge M. Prospective cohort analysis of the predictive validity of a screening instrument for severe restrictions of work ability in patients with musculoskeletal disorders. Am J Phys Med Rehabil. 2015;94(8):617–26.

    Article  PubMed  Google Scholar 

  41. Bethge M, Spanier K, Neugebauer T, Mohnberg I, Radoschewski FM. Self-reported poor work ability—an indicator of need for rehabilitation? a cross-sectional study of a sample of german employees. Am J Phys Med Rehabil. 2015;94(11):958–66.

    Article  PubMed  Google Scholar 

  42. Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics. 2009;50(6):613–21.

    PubMed  Google Scholar 

  43. Bührlen B, Gerdes N, Jäckel WH. Development and psychometric testing of a patient questionnaire for medical rehabilitation (IRES-3). Rehabilitation. 2005;44(2):63–74.

    Article  PubMed  Google Scholar 

  44. Dutton SN, Bauman A, Dennis SM, Zwar N, Harris MF. Resourcing an evolution of roles in general-practice: a study to determine the validity and reliability of tools to assist nurses and patients to assess physical activity. Aust J Prim Health. 2017;22(6):505–9.

    Article  Google Scholar 

  45. EHEMU/EHLEIS. The Minimum European Health Module. EHEMU Technical report 2010. Montpellier: France: European Health Expectancy Monitoring Unit; 2010.

  46. Kinnunen U, Nätti J. Work ability score and future work ability as predictors of register-based disability pension and long-term sickness absence: a three-year follow-up study. Scand J Public Health. 2018;46(3):321–30.

    Article  PubMed  Google Scholar 

  47. Hoebel J, Müters S, Kuntz B, Lange C, Lampert T. Measuring subjective social status in health research with a German version of the MacArthur Scale. Bundesgesundheitsbl. 2015;58(7):749–57.

    Article  Google Scholar 

  48. Streibelt M, Bethge M, Gross T, Herrmann K, Ustaoglu F, Reichel C. Predictive validity of a screening instrument for the risk of non-return to work in patients with internal diseases. Arch Phys Med Rehabil. 2017;98(5):989–96.

    Article  PubMed  Google Scholar 

  49. Bethge M, Radoschewski FM, Gutenbrunner C. The work ability index as a screening tool to identify the need for rehabilitation: longitudinal findings from the second German sociomedical panel of employees. J Rehabil Med. 2012;44(11):980–7.

    Article  PubMed  Google Scholar 

  50. El Fassi M, Bocquet V, Majery N, Lair ML, Couffignal S, Mairiaux P. Work ability assessment in a worker population: comparison and determinants of work ability index and work ability score. BMC Public Health. 2013;13(1):305.

    Article  PubMed  PubMed Central  Google Scholar 

  51. Ahmad S, Harris T, Limb E, Kerry S, Victor C, Ekelund U, et al. Evaluation of reliability and validity of the General Practice Physical Activity Questionnaire (GPPAQ) in 60–74 year old primary care patients. BMC Fam Pract. 2015;16(1):1–9.

    Article  CAS  Google Scholar 

  52. De Bruin A, Picavet H, Nossikov A. Health interview surveys: towards international harmonization of methods and instruments. WHO Regional Publications, European Series, No. 58. Copenhagen: ERIC; 1996.

  53. Lampert T, Schmidtke C, Borgmann L-S, Poethko-Müller C, Kuntz B. The subjective health of adults in Germany. J Health Monit. 2018;3(2):61–8.

    PubMed  PubMed Central  Google Scholar 

  54. Mohnberg I, Spanier K, Peters E, Radoschewski FM, Bethge M. Determinants of intention to apply for medical rehabilitation in patients with prior sickness benefits. Rehabilitation. 2016;55(2):81–7.

    CAS  PubMed  Google Scholar 

  55. Rentenversicherung D. Versicherte 2019. Statistik der Deutschen Rentenversicherung. Berlin: Deutsche Rentenversicherung Bund; 2021.

  56. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1(2):100–7.

    Article  PubMed  PubMed Central  Google Scholar 

  57. Kuckartz U. Qualitative text analysis: A guide to methods, practice and using software: Sage; 2014.

Download references


We thank the involved persons of the GP practices and the German Pension Insurance for their cooperation and efforts in conducting the study, and Susanne Rossek and Christin Lissat for monitoring the practices and supporting data collection. We acknowledge financial support from the Open Access Publication Fund of Charité – Universitätsmedizin Berlin and the German Research Foundation (DFG).


Open Access funding enabled and organized by Projekt DEAL. This study is funded by the German Pension Insurance Berlin-Brandenburg, 15228 Frankfurt (Oder), Germany (grant number: 10-R- Funding covers personnel, material, and travel costs. The study design, data collection, data analysis, data interpretation and writing of the study protocol are not influenced by the funding body. We acknowledge financial support from the Open Access Publication Fund of Charité – Universitätsmedizin Berlin and the German Research Foundation (DFG).

Author information

Authors and Affiliations



MB conceived the study and has driven the funding acquisition together with KS. MB is in charge of the project. MB and JB developed and specified the study design and the intervention. JB is responsible for the implementation of the intervention and data collection in the general practices. JB prepared the first draft of the manuscript, MB revised the manuscript. All authors read and approved the final manuscript. All authors fulfil the authorship criteria of the International Committee of Medical Journal Editors.

Corresponding author

Correspondence to Jennifer Marie Burchardi.

Ethics declarations

Ethics approval and consent to participate

The study is carried out in accordance with the Declaration of Helsinki. The study protocol has been approved by the Ethics Committee of the Charité – Universitätsmedizin Berlin, Berlin, Germany (number: EA4/215/21). No legal or ethical concerns were identified. Informed consent will be obtain from all subjects and/or their legal guardian(s). All participants will receive a written study information about the study objectives, participation, and their right to decline participation. On 03 March 2022, the study was prospectively registered in the German Clinical Trials Register (DRKS00028303, UTN U11111-1275–0063). The World Health Organization Trial Registration Data Set is available as Additional File 2. Significant changes are sent to the Ethics Committee for approval before introduction. Modifications will be documented in the German Clinical Trials Register and reported transparently in study reports.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Burchardi, J.M., Spyra, K. & Brünger, M. Effectiveness of a screening tool to assess prevention and rehabilitation needs of 45 to 59 years old in primary care – study protocol of a pragmatic randomized controlled trial (PReHa45). BMC Health Serv Res 23, 382 (2023).

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: