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:

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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