Here is the structured PICO analysis for the sixteenth article you uploaded:
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Full Title (verbatim and exact):
“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)”
Götze K, Bausewein C, Feddersen B, et al.
Trials (2022); 23:770
DOI: https://doi.org/10.1186/s13063-022-06576-3
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Type of Article:
Study protocol for a multi-centre cluster-randomised controlled trial (cRCT) with health economic and process evaluation components
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PICO Analysis:
Population:
- Nursing home residents in 48 nursing homes across Germany (~3,840 residents)
- Inclusion: All long-term residents, regardless of decisional capacity
- Exclusion: Facilities already offering structured ACP or those specialising in very specific populations (e.g., vegetative state only)
Intervention:
A complex, multimodal advance care planning (ACP) intervention involving:
1. Individual level:
- Structured ACP conversations with certified facilitators, residents, surrogates, and treating physicians
- Documentation of preferences using standardised German ACP forms (AD, AD by proxy, POLST-E)
2. Institutional level:
- Organisational development within nursing homes (NHs), hospitals, EMS
- Steering groups and staff education to ensure preferences are known and honoured
3. Regional level:
- Regional ACP coordination, standardisation, and creation of ACP networks across local health systems
Comparator:
- Usual care without a structured ACP program
- Control group NHs continue with standard practice and are offered the intervention after the observation period
Outcome:
1. Person-centred outcomes:
- Primary outcome (proxy for care alignment):
- Annual hospital admission rate per 100 residents at the NH level
- Secondary person-centred outcomes include:
- Consistency between care preferences and treatment decisions in life-threatening events (3CP tool)
- Place of death, use of life-sustaining treatments (CPR, ventilation), palliative care, and satisfaction with care from families
2. Process outcomes:
- Use of ACP documentation (ADs, POLST forms, surrogate identification)
- Extent and quality of shared decision-making (SDM) processes
- Resident and family involvement in planning
- Staff knowledge and institutional integration of ACP practices
3. Health system outcomes:
- Cost of care (health economic evaluation from payer perspective)
- Use of emergency medical services (EMS), ICU stays, and hospice services
- Cost-effectiveness analysis: Incremental cost per hospitalisation avoided or care-consistent outcome achieved
Summary Conclusion:
The BEVOR trial evaluates a large-scale, regionally coordinated ACP intervention across German nursing homes. By addressing individual decision-making, institutional structures, and regional systems, the trial aims to reduce non-beneficial hospitalisations and improve care consistency with residents’ values. The study uses a pragmatic design with a robust economic and process evaluation and a primary outcome that balances methodological rigour and ethical feasibility. Results will inform policy on scaling ACP nationally.
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