Trial Description

Title

Active access, counseling and case management for insured persons at high risk of disability - development and implementation

Trial Acronym

AktiFAME-ENGINE

URL of the Trial

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Brief Summary in Lay Language

This study protocol describes the mixed-methods study, with which we accompany the development and implementation of a case management program. Our research project AktiFAME is funded by the Federal Ministry of Labor and Social Affairs as part of the federal funding program rehapro (https://www.modellvorhaben-rehapro.de). In order to recruit participants, we write to people for whom we have determined an increased risk of receiving a disability pension. This risk is calculated using administrative data from the German Pension Insurance North. These persons will be offered a one-to-one consultation with a case manager. This can be followed by an individual, needs-oriented case management intervention. Up to 50 contacts within one year are planned if a case management intervention is initiated. During the pilot phase we will accompany the first 30 participants. We use questionnaire data, administrative data and data describing the implementation of the case management intervention. We also conduct in-depth interviews with participants and case managers.
To test the effectiveness of the intervention, a randomized controlled trial is conducted after successful piloting. For this randomized controlled trial, a separate study registration will be prepared.

Brief Summary in Scientific Language

Employment is a key resource for participation in society. It secures income, guarantees material security and supports an independent lifestyle. In addition, the accumulation of pension entitlements reduces the risk of poverty in old age.
If people become chronically ill, e.g. due to mental illness, this may jeopardize staying at work and future work participation. In case of long-term and presumably permanent work disability, a pension for full or partial loss of earnings can then be granted to reduce income losses. Disability pensions are usually granted for a limited period. After nine years, they are converted into permanent pensions. Currently, more than 1.8 million people in Germany are receiving a disability pension. Every year, about 340,000 applications for a disability pension were received. Slightly more than half of the completed cases were approved. In relation to the insured population, disability pensions are rather rare events. Four to five out of every 1000 actively insured persons start a disability pension every year. The 5-year incidence is just under 2%. Most pensions are full disability pensions (87.4%), 12.6% are partial pensions. In the case of a full disability pension, an individual receives on average 776 euros net before tax per month. A partial pension averages 450 euros. Expenditure on disability pensions annually accumulates to just under 19 billion euros.
Most recently, around 170,000 people in Germany received a disability pension for the first time. Slightly more than half of the people who started a disability pension are women. 80% of the new pensioners live in the old federal states and 20 % in the new federal states. The average age of receiving a disability pension for the first time was around 52, i.e. about 15 years before the regular pension age. Women are slightly younger when they retire. The most important underlying health problem is mental illness. Mental disorders are responsible for about 43% of all new disability pensions. Mental disorders have replaced musculoskeletal disorders as the leading diagnostic group. Musculoskeletal disorders are now only the third most important disease group after cancer.
According to Article 27(1) of the Convention on the Rights of Persons with Disabilities, persons with disabilities have “the right to the opportunity to gain a living by work freely chosen or accepted in a labor market and work environment that is open, inclusive and accessible to persons with disabilities.” This requires assistance in the transition to the general labor market and the promotion of the job re-entry of people with disabilities. The range of such support services provided under German social law is broad (e.g. medical rehabilitation, retraining or job adjustments). Frequently, several of these services are needed to enable people to return or remain in employment. Different service providers may be involved, such as pension insurance, job centers, the employment agency, social welfare institutions and health insurance agencies. Employers, occupational health physicians, general practitioners or psychotherapists are also important players. This is often an enormous networking task for the persons in need. Moreover, it is often not clear to whom the persons have to turn to in order to apply for services.
To meet these challenges, coordinating and accompanying interventions have been proposed and implemented in recent years. In a systematic review of such approaches, 14 randomized controlled trials with 12,568 employees were compiled. The people included in these studies had musculoskeletal or mental health problems and had to be on sick leave for at least four weeks. The authors did not find any benefits of the case management approaches investigated for returning to work. The authors described small benefits for patient-reported outcomes (e.g. pain and functional capacity). However, the differences were not clinically significant. The quality of the evidence was considered low due to the risk of bias and the low precision of the effect estimators. The transferability of these results to the care of people with a high risk of permanent withdrawal from the labor market is severely limited due to the low-threshold for including workers (at least four weeks of incapacity to work) and the high variability of the interventions described. A recent randomized controlled trial from Denmark was able to show higher reintegration rates in favor of the intervention group when reaching a target group that had very clear limitations and an obvious need for coordinating support.
In our study we adopt the described coordinating approaches. Supported by the federal funding program rehapro, we are developing and piloting a case management intervention for people who have a high risk of receiving a disability pension. We will identify these people using administrative data from the German Pension Insurance North. For this purpose, these data will be aggregated to a risk score. People with high risk scores (at least 60 points) will be contacted by the German Pension Insurance North and offered a consultation with an external case management provider. This can be followed by an individual, needs-oriented case management intervention. We expect from this complex intervention that people with a high risk of a disability pension receive the tailored support necessary to secure their work ability and work participation.
This study protocol refers to the development and piloting of the intervention. We intend that 30 people identified by the risk score will participate in the new case management intervention during the pilot phase.
Our study clarifies the following questions.
1. How many and which persons attend the initial interview and the subsequent case management?
2. How is the intervention implemented?
3. What changes in work, participation and health outcomes can be observed for case management participants?
4. How many people use rehabilitation services of the German Pension Insurance after the start of the case management intervention?
At the end of the pilot phase, tested and revised manuals for the implementation of the intervention are available.
To test the effectiveness of the intervention, a randomized controlled trial will be conducted after successful piloting our case management intervention. A separate study registration is made for this randomized controlled trial.

Do you plan to share individual participant data with other researchers?

No

Description IPD sharing plan:

No as the study monitors the piloting of a new intervention.