Background
Mental and neurological disorders are common and severe health threats, so they play a decisive role in health care [
1,
2]. It is estimated that about 27% of the adult EU population, is or has been affected by at least one mental disorder in the past 12 months [
3]. Mental disorders are related to a high degree of personal suffering, disease burden, and health impairment [
1,
4]. Several mental disorders, such as depression, alcohol use disorders, bipolar disorders, schizophrenia, and panic disorders, are among the 20 leading causes of disability [
2]. Multiple sclerosis, one of the most relevant neurological disorders, is related to impairment of functioning and quality of life [
5]. Consequently, mental and neurological disorders represent a major challenge for the health care system and produce high direct as well as indirect costs [
6,
7].
The German health care system consists of different health care sectors: primary and specialist care in the outpatient setting, and inpatient care. Statutory or private health insurances cover health care costs; whereby 90% are covered by statutory health insurances. For treatment of mental and neurological disorders, patients can seek GPs, specialist outpatient care from psychiatrists, neurologists, psychotherapists, specialists in psychosomatic medicine as well as inpatient care in neurologic, psychiatric, or psychosomatic hospitals. Although a well-developed mental health care system exists, there is still need for improvement regarding early and correct detection of mental illnesses in primary care and regarding the reduction of intersectoral barriers. For example, GPs can generally identify only about half of the patients with depression and can accurately exclude four of five non-depressed individuals [
8]. In addition, there are large delays between detection and adequate treatment of mental disorders [
9,
10]. Consequently, patients are on greater risk to maintain high degrees of burden [
11‐
13], lose their motivation to seek treatment or seek treatments that are not sufficiently evidence-based. Even at treatment initiation, speration of the responsibilities of health care providers in differenct sectors impede changing health care sectors (e.g. primary care, specialist care, and inpatient care) [
12]. This fragmented mental health care system is a major weakness in Germany [
14]. Consequently, overcoming those intersectoral barriers by developing innovative care networks may optimize care of patients with mental and neurological disorders.
To organize patient-centered care, integrated care models may be useful. Clinical practice guidelines recommend stepped and collaborative care models for the treatment of depressive [
15] and anxiety disorders [
16]. Stepped care aims to tailor evidence-based interventions to patients’ needs, starting with the lowest intensity [
17]. In case of non-response, patients receive the next higher level of treatment intensity. Collaborative care aims to strengthen cooperation between different health care providers in order to provide evidence-based and comprehensive treatment.
Studies indicate that stepped and collaborative care models are effective and improve outcomes (e.g. adherence, reduction of depressive symptoms) compared to treatment as usual among patients with depression [
18]. A meta-analysis calculated small to medium effect sizes for the effectiveness of collaborative care (depression, mental and physical quality of life, social role function) compared to usual care or with less integrated models (e.g. patient education, consultation-liaison services) among patients with mental disorders [
19]. The results of two meta-analyses provide evidence for the effectiveness of collaborative care models compared to care as usual in reducing symptoms among patients with anxiety disorders (standard mean difference = 0.35 95% CI 0.14–0.56) [
20] and depression (standard mean difference = 0.34 95% CI 0.25–0.43) [
21]. In addition, collaborative care models improve adherence, quality of life, and satisfaction with care among patients with depression [
21]. Among patients with multiple scleroses, a long term observational study without control groups did not find effects on disability and health related quality of life [
22].
Cost-effectiveness studies showed that the collaborative care models lead either to decreased costs or to slightly increased costs, whereas quality of health care was considerably improved. Although, costs for outpatient care usually increase through collaborative care models, costs for inpatient care decrease [
6,
23]. For instance, collaborative care models lead to savings in costs after 2 years among patients with depression [
24] and lead to a reduction of acute inpatient treatments among patients with multiple sclerosis [
22]. Due to a decrease in days of incapacity to work, indirect costs are reduced among patients with depression [
25]. Thus, collaborative care models demonstrate a favorable cost-benefit ratio among patients with mental disorders [
26]. However, there is a lack of evidence for the effectiveness of collaborative care programs for patients with multiple sclerosis.
In contrast to other countries, the majority of health care costs in Germany arise from inpatient treatment. To address problems with the fragmented mental health care system in Germany, selective care contracts between particular statutory health insurance companies and health care providers can be concluded in accordance with the German Social Security Code V [
27]. These selective care contracts regulate parts of the primary and outpatient care beyond standard care (which is regulated in the collective contract) among people with statutory health insurance. Statutory health insurance companies are committed to provide insurees opportunies for certain selective care contracts (contracts regarding general practitioners-centered care). Health care providers and patients can participate voluntarily in selective care models.
Two selective care programs developed and implemented by the German statutory health insurance AOK Baden Wuerttemberg (AOK BW) are the “general practitioners program” (“HausarztProgramm”) and the “specialist program” (“FacharztProgramm”). Insurees enrolled in the “specialist program” can receive care in the so-called PNP program, if they need care in the fields of psychiatry, neurology, psychosomatics and psychotherapy. The PNP program aims to strengthen collaboration between different health care providers and provision of individualized, guideline-based and biopsychosocial outpatient treatment. Therefore, correct and detailed diagnoses are needed. Differences between components of interventions compared to usual care are described in Table
1. The AOK BW comprehensively implemented the PNP program in Baden-Wuerttemberg (Southwest Germany) and 590,000 patients are receiving care within the specialist program (February 2018). This program needs to be evaluated.
Table 1
Differences between components of interventions
Requirements for participation (patients) | - free choice of health care providers with a license in Baden-Wuerttemberg | - minimum time of participation: 12 months - commitment to seek help from GPs enrolled in the program only - commitment to seek help from GPs first (exception: emergencies, gynecologist, ophthalmologists, pediatricians) | - enrolled in the general practitioners program and the specialist program - minimum time of participation: 12 months - commitment to seek help from health care providers enrolled in the program only - commitment to seek help from GPs first (exception: emergencies, gynecologist, ophthalmologists, pediatricians) |
Requirements for participation (health care providers) | - license in Baden-Wuerttemberg | - license in Baden-Wuerttemberg - GP | - license in Baden-Wuerttemberg - psychotherapists and specialists in psychiatry, neurology, psychotherapy, or psychosomatic medicine - enrolment in at least one of three modules: psychiatry, neurology, psychotherapy |
Role of GPs | - diagnosis, treatment, referral to specialists | - diagnosis, treatment, referral to specialists - guiding through care: structured coordinating and communication to specialists care and merging results of medical examinations | - diagnosis, treatment, referral to specialists - guiding through care: structured coordinating and communication to specialists care and merging results of medical examinations |
All providers |
Compensation and diagnoses | - health care services for patients with specific and unspecific diagnoses in accordance with ICD-10 are billable | - health care services for patients with specific and unspecific diagnoses in accordance with ICD-10 are billable - fee for cooperation with specialists | - health care services for patients with predominantly specific diagnoses in accordance with ICD-10 are billable (e.g., for depressive disorders, only the specific codes F32.0-F32.3, F33.0-F33.4 are billable; the unspecific codes F32.8, F32.9, F33.8, and F33.9 are not billable) - fee for cooperation with specialists and GPs |
Social service | - social service of the AOK Baden Wuerttemberg | - more structured cooperation between health care provider and social service of the AOK Baden Wuerttemberg | - more structured cooperation between health care provider and social service of the AOK Baden Wuerttemberg |
Quality management | - mandatory continuous training courses | - mandatory continuous training courses - participation in quality circles on drug therapy (once per quarter) for GPs | - mandatory continuous training courses - participation in quality circles on drug therapy (once per quarter) for GPs (optional for specialists) |
Psychotherapy |
Differences in compensation | - higher payment of regular sessions compared to preparatory sessions (2–4 preparatory sessions) | - higher payment of regular sessions compared to preparatory sessions (2–4 preparatory sessions) | - higher payment for first sessions (acute / initial care = 10/20 sessions) compared to long-term therapy and compared to usual care - higher payment for group psychotherapy compared to usual care - collective incentives for saving sickness benefits |
Organization | - review process for approval of long-term psychotherapy | - review process for approval of long-term psychotherapy | - no review process for approval of long-term psychotherapy |
Treatment content | - Cognitive Behavioral Therapy - Psychodynamic Psychotherapy - Psychoanalytic therapy - Neuropsychological therapy - Hypnosis - Eye Movement Desensitization and Reprocessing (EMDR) | - Cognitive Behavioral Therapy - Psychodynamic Psychotherapy - Psychoanalytic therapy - Neuropsychological therapy - Hypnosis - Eye Movement Desensitization and Reprocessing (EMDR) | - Cognitive Behavioral Therapy - Psychodynamic Psychotherapy - Psychoanalytic therapy - Additional treatment methods depending on diagnosis: ○ Neuropsychological therapy ○ Hypnosis ○ Eye Movement Desensitization and Reprocessing (EMDR) ○ Systemic psychotherapy ○ Biofeedback ○ Interpersonal therapy |
Additional guidelines on accessibility | / | / | - for acute cases: initial session within 3 days; start of psychotherapy within 7 days after established diagnosis - for initial treatment: start of psychotherapy within 4 weeks after established diagnosis |
Psychiatry |
Additional compensation | / | / | - additional supplements for → counselling (e.g. supportive counselling for patients with depression) → provision of technical equipment → prescription of discounted medication → collective incentives for the prevention of hospital admissions |
Additional guidelines on accessibility | / | / | - limit of waiting time up to 30 min - for acute cases: first doctor’s appointment within the same day |
Neurology |
Additional compensation | / | / | - additional supplements for → counselling (e.g. Multiple Sclerosis counselling: 6 units of 20 min per year) → provision of assistants (e.g. with special training on Multiple Sclerosis care) |
Additional guidelines on accessibility | / | / | - limit of waiting time up to 30 min - for acute cases: first doctor’s appointment within the same day |
In summary, international evidence shows that collaborative care models leads to long-term improvement in patient reported outcomes as well as to reduced costs among patients with mental disorders. To evaluate the benefit of collaborative care models, effects of these models need to be assessed from different perspectives considering various outcome parameters. Nonetheless, multi-perspective and comprehensive evaluations of collaborative care models, like the PNP program implemented in Germany, are currently lacking. Hence, the purpose of this study is to evaluate the PNP program.
Discussion
This multiperspective evaluation study will examine the effectiveness, direct and indirect costs, impact on level of detail of depression diagnoses, as well as structure and process quality of the PNP program among patients with mental and neurological disorders. To the best of our knowledge, this is the first independent and multiperspective study evaluating a comprehensive selective health care program including a collaborative care model for patients with mental and neurological disorders in Germany. This study will counteract the lack of systematic evaluations of complex care models in Germany.
The results are primarily applicable for evaluation of the specific intervention, namely the PNP program. In addition, transferability of the results to other collaborative care models can be examined due to the description of the components of the PNP program. We assume that other collaborative care models include similar components. No conclusions can be drawn about the gain of certain components of the PNP program due to the focus of evaluating a complex intervention. However, the results concerning structure and process quality will generate knowledge about acceptance and feasibility of certain components.
One major strength is the multiperspective approach of this evaluation study. We will evaluate the PNP program taking into account the perspective of patients and health care providers and the health care costs. A collaborative care model adds value to standard care, if it provides improved health related outcomes and satisfaction with care for patients or if it saves costs while patients receive comparable improvements. In addition to the effectiveness and direct and indirect costs, new health care models need to be feasible and acceptable for health care providers. Hence, it is necessary to consider these different perspectives when evaluating those models.
Additionally, we will conduct this evaluation study in routine care, which implies external validity of our results.
Moreover, we will conduct this study with academic and methodological rigor to gain robust results. For instance, we will use instruments with proven psychometric properties. To distinguish between effects on quality of life among all patients and symptom-related outcomes, we will use both generic and illness-specific measurements. Concerning structure and process quality, we will use an elaborate exploratory sequential design [
29] combing qualitative and quantitative methods to describe of relevant aspects in a differentiated manner on the one hand and to gain representative results on the other hand.
Instead of randomization, patients choose the intervention based on their preference. This non-randomized design has implications for the internal validity of our study (possible selection and performance bias). To partially control for selection bias, we will perform entropy balancing. Nevertheless, potentially unknown confounders may influence the choice of the program.
In order to investigate the effect of the intervention among patients with a new episode of their disorder, we will include patients who will be on sick leave due to one of the focused mental or neurological disorders at the first time during the previous 12 months. Health insurances receive diagnoses on certificates of incapacity immediately whereas claims data are only available several months after medical appointments. In order to recruit study participants as soon as possible after medical appointments, inclusion relying on diagnoses on certificates of incapacity is the most viable solution. However, participants may have had the same symptoms in previous periods – but without being on sick leave.
Due to limited resources, we will not be able to perform standardized diagnostic interviews to confirm formal diagnoses. Especially in primary care, clinical diagnostics of mental illnesses can differ from standardized diagnostic interviews [
8]. We will address this difficulty by including all routine diagnoses from different health care providers and by measuring severity of symptoms with standardized disorder-specific questionnaires.