Local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro): study protocol of a randomised comparative effectiveness trial.

BACKGROUND: Multimorbid older adults suffering from a long-term health condition like depression, diabetes mellitus type 2, dementia or frailty are at high risk of losing their autonomy. Disability and multimorbidity in the older population are associated with social inequality and lead to soaring costs. Our local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro-Care) aims at improving outcomes for older multimorbid patients with chronic conditions whose social and medical care must be improved. METHODS: The study will evaluate the effects of LoChro-Care on functional health, depressive symptoms and satisfaction with care, resource utilisation as well as health costs in older persons with long-term conditions. The trial will compare the effectiveness of LoChro-Care and usual care in a cross-sectoral setting from hospital to community care. We will recruit 606 older adults (65+) admitted to local hospital inpatient or outpatient departments who are at risk of loss of independence. Half of them will be randomised to receive the LoChro-Care intervention, comprising seven to 16 contacts with chronic care managers (CCM) within 12 months. The hypothesis that LoChro-Care will result in better patient-centred outcomes will be tested through mixed-method process and outcome evaluation and valid measures completed at baseline and at 12 and 18 months. Cost-effectiveness analyses from the healthcare perspective will include incremental cost-effectiveness ratios. DISCUSSION: The trial will provide evidence about the effectiveness of local, collaborative, stepped and personalised care management for multimorbid patients with more than one functional impairment or chronic condition. Positive results will be a first step towards the implementation of a systematic cross-sectoral chronic care management to facilitate the appropriate use of available medical and nursing services and to enhance self-management of older people. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 ; Trial registration date: 02. February 2018.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

Coordinated Treatment of Depression in Elderly People in Primary Care.

BACKGROUND: Depression in the elderly is mainly treated by primary care physicians; the treatment is often suboptimal because of the limited resources available in pri- mary care. New models of care in which treatment by a primary care physician is supplemented by the provision of brief, low-threshold interventions mediated by care managers are showing themselves to be a promising approach. METHODS: In this open, cluster-randomized, controlled study, we sought to determine the superiority of a model of this type over the usual form of treatment by a primary care physician. Patients in primary care aged 60 and above with moderate depres- sive manifestations (PHQ-9: 10-14 points) were included in the study. The primary endpoint was the percentage of patients in remission (score <5 on the Patient Health Questionnaire, PHQ-9) after the end of the intervention (12 months after baseline). The study was registered in the German Clinical Studies Registry (Deutsches Register für Klinische Studien) with the number DRKS00003589. RESULTS: 71 primary care physicians entered 248 patients in the study, of whom 109 were in the control group and 139 in the intervention group. In an intention-to-treat analysis, the remission rate at 12 months was 25.6% (95% confidence interval [18.3; 32.8]) in the intervention group and 10.9% [5.4; 16.5]) in the control group (p = 0.004). CONCLUSION: This study demonstrates the superiority of the new care model in the primary care setting in Germany, as has been found in other countries.

[Implementation of the GermanIMPACT collaborative care program: A qualitative study on the perspective of care managers and supervisors]. / Implementierbarkeit des GermanIMPACT Collaborative Care Programms zur Unterstützung der hausärztlichen Versorgung älterer depressiver Menschen - eine qualitative Interviewstudie.

BACKGROUND: Collaborative Care programs like the Improving Mood Promoting Access to Collaborative Care Program (IMPACT) present an opportunity to support primary care for elderly depressed patients. The GermanIMPACT study evaluates whether this low-threshold model using short behavioral interventions that are conducted by care managers and supervised by a psychotherapist/psychiatrist, is as effective as in other countries. Besides effectiveness, the feasibility of the intervention is also essential for the implementation of the program. METHOD: Care managers and supervisors were interviewed using a qualitative interview guide with questions concerning feasibility and effectiveness of the GermanIMPACT intervention, and the interviews were then evaluated using qualitative content analysis. RESULTS: The interviewees provided important information on how to optimize the realization of the intervention by selecting patients more carefully and by providing case managers with more training. Moreover, the intervention was described as being supportive of patients and as providing relief for general practitioners. Whereas interviewees wanted the intervention to be expanded to other disorders, they simultaneously highlighted the limits of the intervention. CONCLUSIONS: The present study provides practical information for implementing the GermanIMPACT model. Thus, specific recommendations for implementation into standard care can be derived.

Collaborative treatment of late-life depression in primary care (GermanIMPACT): study protocol of a cluster-randomized controlled trial.

BACKGROUND: Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatment of late-life depression (GermanIMPACT trial) in the German primary care context. GermanIMPACT was developed as an adaptation of a successful and widely used American model. The aim of the study is to evaluate the model's applicability to the German primary care setting and its cost-effectiveness. METHODS/DESIGN: The study will be conducted as a cluster-randomized controlled trial comparing the development of depressive symptoms in primary care patients who either receive treatment as usual (control arm) or treatment according to the GermanIMPACT model (intervention arm). In two German cities (Freiburg and Hamburg), a total of 60 general practice offices will be selected and randomized. Each general practice office will be asked to enroll five patients into the trial who are 60 years of age or older and who show moderate depressive symptoms in the scope of a diagnosed depressive episode, recurrent depressive disorder, or dysthymia. General practices in the control arm will provide treatment as usual; general practices in the intervention arm will work closely with a specially trained care manager and a supervising mental health specialist. Evidence-based elements of the treatment plan manual include patient education, identification and integration of positive activities into the daily routine, relapse prevention, and training of problem-solving techniques as needed. The intervention period per patient will be one year. Data will be collected at baseline, 6, and 12 months. Primary outcome is the patient-reported change of depressive symptoms (Patient Health Questionnaire, PHQ-9). Secondary outcomes include measures of quality of life, anxiety, depression-related behavior, problem-solving skills, resilience, and an overall economic evaluation of the program. DISCUSSION: The GermanIMPACT trial will provide evidence about the effectiveness, feasibility, and cost-effectiveness of collaborative stepped care in treating late-life depression in German primary care. Positive results will be a first step toward integrating specialized depression care managers into the primary care setting. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00003589 (September 2012).