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Background Collaborative, nurse-led care is a well-established model of ambulatory care in many healthcare systems. Nurses play a key role in managing patients' conditions as well as in enhancing symptom- and self-management skills. Objective The SMADS trial evaluated the effectiveness of a primary care-based, nurse-led, complex intervention to promote self-management in patients with anxiety, depressive or somatic symptoms. Change in self-efficacy 12 months post baseline was used as the primary outcome. Design The SMADS trial set up a two-arm, cluster randomised controlled trial in the city of Hamburg, a large metropolitan area in the North West of Germany. Setting We randomly allocated participating primary care practices to either the intervention group (IG), implementing a nurse-led collaborative care model, or to the control group (CG), where patients with the above psychosomatic symptoms received routine treatment. Participants Patients from 18 to 65 years of age, regularly consulting a participating primary care practice, scoring≥5 on the anxiety, depressive or somatic symptom scales of the Patient Health Questionnaire (PHQ-D), German version. Methods A mixed model regression approach was used to analyse the outcome data. Analyses were based on the intention-to-treat population: All enrolled patients were analysed at their follow-up. Additionally, we reported results as effect sizes. The robustness of the results was investigated by performing an observed cases analysis. Results 325 participants (IG N=134, CG N=191) from ten practices in each study arm consented to take part and completed a baseline assessment. The mean group difference (ITT-LOCF, IG vs. CG) in self-efficacy at the post baseline follow-up (median 406days) was 1.65 points (95% CI 0.50–2.8) in favour of IG (p=0.004). This amounts to a small Cohen's d effect size of 0.33. An observed cases analysis (168 participants, IG=56, CG=105) resulted in a mean difference of 3.13 (95% CI 1.07–5.18, p=0.003) between the groups, amounting to a moderate effect size of d=0.51. Conclusion A complex, nurse-led intervention, implemented as a collaborative care model, increased perceived self-efficacy in patients with symptoms of anxiety, depression or somatisation compare to control patients. For the first time in the German healthcare system, the SMADS trial validated the belief that a nurse can successfully complement the work of a general practitioner – particularly in supporting self-management of patients with psychosomatic symptoms and their psychosocial needs.

Angstbedingte, depressive und somatoforme Storungen (ADSom) kommen in der hausarztlichen Versorgung haufig vor. Zur gezielten Unterstutzung von Patienten mit diesen Storungen erprobt die SMADS-Studie eine komplexe, niedrigschwellige Intervention zur Selbstmanagementforderung (SMF) durch speziell geschulte Pflegekrafte. In dieser Arbeit wird untersucht, wie die Veranderungsmotivation der Patienten vor Beginn der Intervention mit der primaren Zielgrose Selbstwirksamkeit zusammenhangt, um zu erfahren, ob die SMF die geeignete Patientengruppe erreicht.

Background Anxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective. Methods This analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed. Results In total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay. Conclusion The complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.

Background Anxiety, Depression and Somatoform (ADSom) disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners (GPs). Furthermore, the management of these patients is restricted by the high patient turnover rates in primary care practices, especially in the German health care system. In order to address this problem, we implement a complex, low-threshold intervention by an Advanced Practice Nurse (APN) using a mixture of case management and counseling techniques to promote self-management in these patients. Here we present the protocol of the “Self-Management Support for Anxiety, Depression and Somatoform Disorders in Primary Care” (SMADS)-Study. Methods/Design The study is designed as a cluster-randomized controlled trial, comparing an intervention and a control group of 10 primary care practices in each case. We will compare the effectiveness of the intervention applied by an APN with usual GP-care. A total of 340 participants will be enrolled in the study, 170 in either arm. We use the Patient Health Questionnaire-German version (PHQ-D) as a screening tool for psychiatric symptoms, including patients with a score above 5 on any of the three symptom scales. The primary outcome is self-efficacy, measured by the General Self-Efficacy Scale (GSE), here used as a proxy for self-management. As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life. Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment. Discussion The SMADS-study evaluates a complex, low threshold intervention for ambulatory patients presenting ADSom-symptoms, empowering them to better manage their condition, as well as improving their motivation to engage in self-help and health-seeking behaviour. The benefit of the intervention will be substantiated, when patients can enhance their expected self-efficacy, reduce their symptom load and engage in more self-help activities to deal with their everyday lives. After successfully evaluating this psychosocial intervention, a new health care model for the management of symptoms of anxiety, depression and somatoform disorders for ambulatory patients could emerge, supplementing the work of the GP. Trial registration Clinicaltrials.gov Identifier: NCT01726387