Primary Care Disease Management for Venous Leg Ulceration in German Healthcare: Results of the Ulcus Cruris Care Pilot Study.

Despite proven effectiveness, compression therapy is applied in only 20-40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted.

Interprofessional evidence-based counselling programme for complementary and integrative healthcare in patients with cancer: study protocol for the controlled implementation study CCC-Integrativ.

INTRODUCTION: According to international literature, patients with cancer wish to have information on complementary and integrative healthcare (CIH). Medical guidelines recommend actively approaching patients with cancer discussing potential benefits and risks of individual CIH methods. While some CIH methods, for example, acupuncture and yoga, have been proven effective in high-quality studies, other CIH methods lack studies or bear the risk of interactions with chemotherapeutics, for example, herbal drugs. Therefore, an evidence-based interprofessional counselling programme on CIH will be implemented at four Comprehensive Cancer Centres in the federal state of Baden-Wuerttemberg, Germany. METHODS AND ANALYSIS: A complex intervention consisting of elements on patient, provider and system levels will be developed and evaluated within a multilayer evaluation design with confirmatory evaluation on patient level. Patients with a cancer diagnosis within the last 6 months will receive three individual counselling sessions on CIH within 3 months (=intervention on patient level). The counselling will be provided by an interprofessional team of medical and nursing staff. For this purpose, an intensive online training programme, a CIH knowledge database and an interprofessional team-building process were developed and implemented (=intervention on provider level). Moreover, training events on the basics of CIH are offered in the outpatient setting (=intervention on system level). Primary outcome of the evaluation at the patient level is patient activation measured (PAM) with the PAM-13 after 3 months. Secondary outcomes, for example, quality of life, self-efficacy and clinical parameters, will be assessed at baseline, after 3 months and at 6 months follow-up. The intervention group (n=1000) will be compared with a control group (n=500, treatment as usual, no CIH counselling. The outcomes and follow-up times in the control group are the same as in the intervention group. Moreover, the use of health services will be analysed in both groups using routine data. A qualitative-quantitative process evaluation as well as a health economic evaluation will identify relevant barriers and enabling factors for later roll-out. ETHICS AND DISSEMINATION: The study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen, No. 658/2019BO1. The results of these studies will be disseminated to academic audiences and in the community. TRIAL REGISTRATION NUMBER: DRKS00021779; Pre-results.

Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126).

BACKGROUND: Venous leg ulcers (VLU) have a prevalence of 1-2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The "Ulcus Cruris Care" project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention. METHODS: The UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation. DISCUSSION: The UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered. TRIAL REGISTRATION: The trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 ( DRKS00026126 ).

Multivariate risk preferences in the quality-adjusted life year model.

The interest in multivariate and higher-order risk preferences has increased. A growing body of literature has demonstrated the relevance and impact of these preferences, but for health the evidence is lacking. We measure multivariate and higher-order risk preferences for quality of life (QoL) and longevity, the two attributes of the Quality-Adjusted Life Year (QALY) model. We observe preferences for a positive correlation between these attributes and for pooling together a fixed loss in one of the attributes and a mean-zero risk in the other, and for pooling together mean-zero risks in QoL and longevity. The findings indicate that higher-order risk preferences are stronger for health than for money. Furthermore, we test if preferences for a risky treatment for a disease affecting only QoL, depend on life expectancy. We find no such a relation, but there is a positive relation between riskiness of a comorbidity affecting life expectancy and risk aversion for a QoL treatment. We therefore observe no definitive deviation from the QALY model, although the model is more robust when expected longevity is high. Our findings suggest that the current practice of cost-effectiveness analysis should be generalized to account for risk aversion in QoL and longevity, and higher-order preferences.

Taking steps towards deinstitutionalizing mental health care within a low and middle-income country: A cross-sectional study of service user needs in the Republic of Moldova.

AIM: The current research was conducted in the context of an ongoing reform of mental health services in the Republic of Moldova since 2014, where efforts have been devoted to creating community-based mental health services. This article presents a snapshot of the needs of mental health service users in the Republic of Moldova and helps to understand how and with which services their needs can be addressed. METHODS: This cross-sectional study compared the levels of needs (CANSAS scale), quality of life (EQ-5D 3L), mental health status (MINI for psychotic disorders) and functioning (WHO-DAS) among mental health service users in the psychiatric hospital in Chisinau, Moldova. All service users resided in districts where community mental health services were being developed. Correlations between quality of life, functioning and unmet need were explored. RESULTS: Of 83 participants, one third had a psychotic or a mood disorder. On average, participants reported needs in 9.41 domains (SD = 4.41), of which 4.29 were unmet (SD = 3.63). Most unmet needs related to intimacy and relation to others. The level of functioning and quality of life were reported. We found strong, negative associations between the number of unmet needs and level of functioning, as well as the quality of life. We also found that higher functioning levels were positively associated with higher quality of life. CONCLUSION: There were a high number of unmet needs among this inpatient population, particularly social needs and service-related needs. A continuum of inpatient and outpatient care and individual treatment plans can help address the different needs of different patients. Individual treatment plans for patients and the choice of the appropriate treatment for patients could be guided by an assessment of service users' (unmet) needs of care and level of functioning.