Prevention of invasive ventilation (PRiVENT)-a prospective, mixed-methods interventional, multicentre study with a parallel comparison group: study protocol.

BACKGROUND: Invasive mechanical ventilation (IMV) is a standard therapy for intensive care patients with respiratory failure. With increasing population age and multimorbidity, the number of patients who cannot be weaned from IMV increases, resulting in impaired quality of life and high costs. In addition, human resources are tied up in the care of these patients. METHODS: The PRiVENT intervention is a prospective, mixed-methods interventional, multicentre study with a parallel comparison group selected from insurance claims data of the health insurer Allgemeine Ortskrankenkasse Baden-Württemberg (AOK-BW) conducted in Baden-Württemberg, Germany, over 24 months. Four weaning centres supervise 40 intensive care units (ICUs), that are responsible for patient recruitment. The primary outcome, successful weaning from IMV, will be evaluated using a mixed logistic regression model. Secondary outcomes will be evaluated using mixed regression models. DISCUSSION: The overall objective of the PRiVENT project is the evaluation of strategies to prevent long-term IMV. Additional objectives aim to improve weaning expertise in and cooperation with the adjacent Intensive Care Units. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT05260853).

Health monitoring among asylum seekers and refugees: a state-wide, cross-sectional, population-based study in Germany.

BACKGROUND: Health monitoring in Germany falls short on generating timely, reliable and representative data among migrants, especially transient and marginalized groups such as asylum seekers and refugees (ASR). We aim to advance current health monitoring approaches and obtain reliable estimates on health status and access to essential healthcare services among ASR in Germany's third largest federal state, Baden-Württemberg. METHODS: We conducted a state-wide, cross-sectional, population-based health monitoring survey in nine languages among ASR and their children in collective accommodation centres in 44 districts. Questionnaire items capturing health status, access to care, and sociodemographic variables were taken from established surveys and translated using a team approach. Random sampling on the level of 1938 accommodation centres with 70,634 ASR was employed to draw a balanced sample of 65 centres with a net sample of 1% of the state's ASR population. Multilingual field teams recruited eligible participants using a "door-to-door" approach. Parents completed an additional questionnaire on behalf of their children. RESULTS: The final sample comprised 58 centres with 1843 ASR. Of the total sample expected eligible (N = 987), 41.7% (n = 412) participated in the survey. Overall, 157 households had children and received a children's questionnaire; 61% (n = 95) of these were returned. Age, sex, and nationality of the included sample were comparable to the total population of asylum applicants in Germany. Adults reported longstanding limitations (16%), bad/very bad general health (19%), pain (25%), chronic illness (40%), depression (46%), and anxiety (45%). 52% utilised primary and 37% specialist care services in the previous 12 months, while reporting unmet needs for primary (31%) and specialist care (32%). Younger and male participants had above-average health status and below-average utilisation compared to older and female ASR. CONCLUSIONS: Our health monitoring survey yielded reliable estimates on health status and health care access among ASR, revealing relevant morbidities and patterns of care. Applying rigorous epidemiological methods in linguistically diverse, transient and marginalized populations is challenging, but feasible. Integration of this approach into state- and nation-wide health monitoring strategies is needed in order to sustain this approach as a health planning tool.

Developing and implementing a complex Complementary and Alternative (CAM) nursing intervention for breast and gynecologic cancer patients undergoing chemotherapy--report from the CONGO (complementary nursing in gynecologic oncology) study.

PURPOSE/OBJECTIVES: The purpose of this study was to develop a complex nursing intervention including complementary and alternative medicine (CAM) for breast and gynecologic cancer patients during chemotherapy to improve quality of life. METHODS: Data sources Theoretical framework and concepts, practical nursing knowledge, and evidence-based studies were compiled in interprofessional meetings. Data synthesis The final complex intervention consists of three autonomous, but interacting components: (1) CAM nursing package, (2) resource-oriented counseling, and (3) evidence-based information material on CAM. CAM interventions include acupressure, aromatherapy, compress, and massage, targeting 14 clinically relevant symptoms during chemotherapy. Participants receive these interventions during chemotherapy with instructions for self care. During a counseling interview, the patient's needs and preferences are assessed by trained nurses. Furthermore, participants are equipped with evidence-based information material (booklet and DVD). Prior to study start, nurses attended training modules for administering CAM therapies and for communicating and counseling within the salutogenic approach. CONCLUSIONS: It was possible to design a multimodal CAM nursing intervention based on a theoretical concept, evidence-based studies, and practical nursing experience targeting the prevention or relief of side-effects women suffer during chemotherapy. The systematic analysis of the CONGO study will contribute to evidence-based CAM nursing care within supportive cancer care. IMPLICATIONS FOR INTEGRATIVE CANCER CARE: Oncology nurses play an important role in supportive CAM care of breast and gynecologic cancer patients in daily clinical practice. Within oncology outpatient services, the implementation of evidence-based CAM nursing interventions and counseling may contribute to understand the impact of nursing on patient quality of life and symptom relief. This can lead to a new understanding of the nurse's professional role.

Spirituality, Self-Care, and Social Activity in the Primary Medical Care of Elderly Patients.

BACKGROUND: Self-efficacy is decisive for the quality of life of elderly, multimorbid persons. It may be possible to strengthenpatients' self-efficacy can be strengthened by the targeted reinforcement of individual spirituality, social activity, and self-care.This hypothesis was tested with the aid of a complex intervention. METHODS: A non-blinded, exploratory, cluster-randomized, controlled trial was carried out, with primary care practices as therandomization unit (registration number DRKS00015696). The patients included were at least 70 years of age, had at least threechronic diseases, were taking at least three medications, and were participating in a disease management program. In theintervention group, primary care physicians took a spiritual history, and medical assistants advised the patients on the use ofhome remedies (e.g., tea, application of heat/cold) and on regionally available programs for the elderly. The primary endpoint-health-related self-efficacy, measured using the SES6G scale-and further, secondary endpoints were evaluated withmultistep regression analyses. RESULTS: Data from 297 patients treated in 24 primary care practices were evaluated. The analysis of the primary endpointindicated no effect (mean difference between study arms 0.30 points, 95% confidence interval [-0.21; 0.81], d = 0.14, p = 0.25).Subgroup analysis revealed the following situation for the secondary endpoint "mental well-being" (SF-12 subscale): patientswho had already been using home remedies before the trial began experienced a marked improvement (a difference of 7.3points on a scale from 0 to 100; d = 0.77, p < 0.001). This was also the case for patients who stated that spirituality played amajor role in their lives (a difference of 6.2 points on a scale from 0 to 100; d = 0.65; p = 0.002). CONCLUSION: The main hypothesis concerning health-related self-efficacy was not confirmed. The results of the analysis ofsecondary parameters indicate that some subgroups of patients can benefit from the interventional approach.

Training General Practitioners and Medical Assistants Within the Framework of HoPES3, a Holistic Care Program for Elderly Patients to Integrate Spiritual Needs, Social Activity, and Self-Care into Disease Management in Primary Care.

BACKGROUND: This study presents a concept for training general practitioners (GPs) in taking a spiritual history. In the same workshop, medical assistants (MAs) were trained in counselling elderly, chronically ill patients on social activities and home remedies. After the training, GPs and MAs will apply the acquired skills in their practices within the scope of the HoPES3 intervention study, which aims at raising patients' self-efficacy. METHODS: Sixteen GPs and 18 MAs were trained in a 5-hour workshop and completed an evaluation questionnaire. RESULTS: All participants reported great satisfaction. In particular, 85% of GPs (n=11) affirmed increased capacity to address patients' spiritual needs. About 88% (n=15) of MAs were satisfied with the training, yet expressed difficulties in integrating theoretical knowledge into daily professional routine. DISCUSSION: While the evaluation of the workshop is promising, the results of the randomized-controlled trial evaluating the effectiveness of the complete HoPES3 intervention have to be awaited. CONCLUSION: To our knowledge, this is the first interdisciplinary, holistic care training in primary care in Germany. It fosters GPs' and MAs' competency in providing a proactive support in spirituality, social activities, and home remedies to their patients. If the concept proves to be effective, it could be integrated into existing care models and curriculums and provide clear guidance on how to consider elderly patients' spiritual needs and strengthen their self-efficacy in primary care settings.

The effects of an integrated supportive care intervention on quality of life outcomes in outpatients with breast and gynecologic cancer undergoing chemotherapy: Results from a randomized controlled trial.

The aim of the Complementary Nursing in Gynecologic Oncology study was to investigate the effects of a complex, nurse-led, supportive care intervention using Complementary and Integrative Medicine (CIM) on patients' quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynecologic cancer undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of CIM applications and counseling for symptom management, as well as CIM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after CHT. Mixed linear models considering fixed and random factors were used to analyze the data. In total, 126 patients were randomly assigned into the IG and 125 patients into the CG (median age 51 years). The patients' medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT (estimate -1.04 [-4.89; 2.81]; P = 0.596), but there was a significant group difference in favor of the IG 6 months later (estimate 6.643 [1.65; 11.64]; P = 0.010). IG patients did also experience significant better emotional functioning (P = 0.007) and less fatigue (P = 0.027). The tested supportive intervention did not improve patients' QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients' completion of CHT. This delayed effect may have resulted due to a strengthening of patients' self-management competencies.