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.

Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory.

BACKGROUND: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. METHODS: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. RESULTS: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. CONCLUSIONS: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02295462 ; November 20, 2014.

[Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel]. / Beratung zu Advance Care Planning in der ambulanten Pflege.

Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel Abstract. Background: StAdPlan is a multicenter, cluster-randomized controlled trial aimed to develop and evaluate an advance care planning (ACP) intervention for the German home care setting. Aim: This paper reports the intervention development. Available ACP concepts were reviewed and adapted to the German home care context in terms of staffing and available time resources. Skilled nurses are assigned to raise the awareness on ACP among older care-dependent people and their informal caregivers/relatives through structured conversation and facilitating the use of existing counselling services. Methods: The Behavior Change Wheel (BCW) was applied to the development of the intervention components. Results: The complex intervention addresses care-dependent people aged 65 years and above and their informal caregivers. A two-day training session qualifies nursing professionals to offer guideline-based conversations which take place at least twice at the care-dependent person's home, if possible with the involvement of relatives. An additional information brochure is provided. Conclusions: The application of the BCW model proved to be appropriate for the analysis, description and definition of the specific functions of the intervention. The intervention is prepared for the effectiveness study.

Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)-study protocol.

BACKGROUND: Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention. METHODS: The planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients' wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data. DISCUSSION: The comprehensive process evaluation will provide essential information on the feasibility of implementation strategies and the clinical relevance of a nurse-led ACP intervention in home care recipients and its generalizability and transferability to other settings. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 . Registered retrospectively on June 4, 2019, first participant included on May 29, 2019.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

[Improving psychosocial health of nursing home residents: a systematic review of interventions for prevention and health promotion]. / Stärkung der psychosozialen Gesundheit von Bewohnerinnen und Bewohnern der stationären Langzeitpflege: Systematische Übersicht zu Interventionen der Prävention und Gesundheitsförderung.

BACKGROUND: Long-term care insurance funds have been mandated by the German Prevention Act to support long-term care facilities in the implementation of health-promoting structures. One area of action is the promotion of the nursing home residents' psychosocial health. The objective of this systematic review was to describe and analyze interventions and intervention components related to the psychosocial health of nursing home residents. METHODS: First, we conducted a search for systematic reviews and meta-analyses in Medline via PubMed, the Cochrane Library, CINAHL, Gerolit, Embase, Psyndex, and Livivo, and hand-searched additional sources. Second, references of all relevant randomized controlled trials (n=86) were extracted from the identified systematic reviews (n=27). The original articles of the included primary studies were then analyzed using criteria for the evaluation of complex interventions. The GRADE approach was used to assess the quality of the evidence. RESULTS: Seventeen interventions for promoting the psychosocial health of nursing home residents were identified. The majority of the study participants were nursing home residents with dementia. Since the underlying evidence was predominantly very low, it was not possible to draw clear conclusions concerning the efficacy of the interventions for psychosocial health outcomes. The best indications of positive effects were found for reminiscence, mealtime interventions, music therapy, and special care staff training. CONCLUSION: The diversity and heterogeneity of the interventions made both classification and consistent judgments of the quality of the evidence difficult. From the perspective of promoting the psychosocial health of nursing home residents, the identified interventions should only be considered as suggestions or proposals for prevention and health promotion measures, and future studies should evaluate their implementation.

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial.

BACKGROUND: antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. OBJECTIVE: we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. DESIGN: a 2-armed 12-month cluster-randomised controlled trial. SETTING: nursing homes in East, North and West Germany. METHODS: all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. RESULTS: the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9-21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038-2.532). CONCLUSIONS: the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02295462.

[Improving cognitive resources of nursing home residents: a systematic review of prevention and health promotion interventions]. / Stärkung kognitiver Ressourcen von Bewohnerinnen und Bewohnern der stationären Langzeitpflege: Systematische Übersicht zu Interventionen der Prävention und Gesundheitsförderung.

BACKGROUND: The German Prevention Act mandated long-term care insurance funds to support long-term care facilities in designing health-promoting structures. One area of action is the promotion of the cognitive resources of nursing home residents. The objective of this systematic review was to describe and analyze interventions and intervention components that improve cognitive resources of nursing home residents. METHODS: First, we conducted a search for systematic reviews to identify relevant randomised controlled trials in Medline via PubMed, the Cochrane Library, CINAHL, Gerolit, Embase, Psyndex, and Livivo; additional sources were hand-searched. Second, references of all relevant randomized controlled trials (n=43) were extracted from the identified systematic reviews (n=26). The original articles of the primary studies included were then considered and data extracted using criteria for the evaluation of complex interventions. The quality of evidence was assessed using the GRADE approach. RESULTS: Nine interventions to promote cognitive resources were identified: cognitive stimulation, cognitive training, physical training, art and music interventions, bright light, multicomponent stimulation, multisensory stimulation, care staff training and reminiscence. The quality of the underlying evidence in the inpatient long-term care setting was predominantly low, therefore, it was not always possible to draw clear conclusions regarding the efficacy of the interventions. The low quality of evidence was mainly due to the high heterogeneity as well as the low number and limited methodological quality of the primary studies. CONCLUSION: In general, a wide range of nonpharmacological interventions were reported. Due to the limited evidence, however, these may be regarded as ideas only or possible options for promoting the cognitive resources of nursing home residents.