Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).

BACKGROUND: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. METHODS: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. DISCUSSION: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

[Assessment of IDC-Pal as a Diagnostic Tool for Family Physicians to Identify Patients with Complex Palliative Care Needs in Germany: a Pilot Study]. / Evaluation des spanischen Diagnostik-Tools für die Komplexität in der Palliativmedizin, IDC-Pal, durch Hausärzte in Deutschland: Eine Pilotstudie.

BACKGROUND: Palliative medicine is an essential component of the health care system. Basic palliative care should be provided by primary care services (family physician and home nursing) with palliative-medical basic qualification. Often it is very difficult to identify patients that would profit from a specialized palliative care team. For the evaluation of the case complexity of a palliative patient, we present a Spanish diagnostic tool IDC-Pal, which tries to specify when, why and where a palliative patient should be referred. The aims of this study were the translation and cultural adaptation of the diagnostic tool for complexity in palliative care IDC-Pal to the German language, and the measurement of its feasibility and face validity. METHODS: During the first phase, a forward-backward translation with linguistic and cultural adaptation of the tool IDC-Pal as well as the validation of its content by a review committee was performed. During the second phase, the preliminary version of the tool was tested by 38 family physicians that were asked for a qualitative assessment using a 10-points Likert scale (1 = "strongly disagree" and 10 = "totally agree"). Finally, a definitive version was developed. RESULTS: The translation and adaptation were achieved without major problems. Both feasibility and apparent validity of the tool IDC-Pal were rated as high. The mean response in the Likert scale was 7.79, with a SD of 0.36. Participants strongly agreed on the apparent validity of the tool with a mean of 7.82 and a SD of 0.26 and on its feasibility with a mean of 7.79, and a SD of 0.39. CONCLUSIONS: A conceptually, culturally and linguistically equivalent version of the original instrument IDC-Pal was obtained. German family physicians agreed on the usability of IDC-Pal as a tool for rating the case complexity of palliative patients. These results indicate that physicians in Bavaria and eventually in Germany could benefit of the full validation of IDC-Pal.

Specialized home palliative care for adults and children: differences and similarities.

OBJECTIVE: To compare the provision of specialized home palliative care (SHPC) by the adult and pediatric SHPC teams at the Munich University Hospital. METHODS: All patients treated by one of the SHPC teams and their primary caregivers were eligible for the prospective nonrandomized survey. We analyzed the demographics, the underlying diseases, duration and impact of SHPC on symptom control and quality of life (QOL) as well as the caregivers' burden and QOL. RESULTS: Between April 2011 and June 2012, 100 adult and 43 pediatric patients were treated consecutively; 60 adults (median age, 67.5 years; 55% male) and 40 children (median age, 6 years, 57% male) were included in the study. Oncologic diseases were dominant only in the adult cohort (87 versus 25%, p<0.001). The median period of care was higher in the pediatric sample (11.8 versus 4.3 weeks; NS). Ninety-five percent of adult and 45% of pediatric patients died by the end of the study (p<0.001), 75% and 90% of them at home, respectively. The numbers of significant others directly affected by the patient's disease was higher in children (mean 3.4 versus 1.2; p<0.001). The QOL of adult patients and children (p<0.05 for both), as well as of their primary caregivers (p<0.001 for both) improved during SHPC, while the caregivers' burden was lowered (p<0.001 for both). CONCLUSIONS: Our results show important differences in several clinically relevant parameters between adults and children receiving SHPC. This should assist in the development of age-group specific SHPC concepts that effectively address the specific needs of each patient population.