Here is the standardised PICO analysis for the twenty-second uploaded article:
Full Title
The design and conduct of a pragmatic cluster-randomized trial of an advance care planning program for nursing home residents with dementia
Authors: Susan E. Hickman, Susan L. Mitchell, Laura C. Hanson, Wanzhu Tu, Timothy E. Stump, Kathleen T. Unroe
Journal: Clinical Trials, 2022; 19(6):623–635
DOI: 10.1177/17407745221108992
Type of Study
Pragmatic cluster-randomised controlled trial (protocol and design paper)
PICO Summary
Population (P)
- Residents with Alzheimer’s disease and related dementias (ADRD) in 137 nursing homes across the United States
- Inclusion: Residents with an ADRD diagnosis or Cognitive Function Scale (CFS) score ≥2
- Exclusion: Residents already on hospice at the study start
- Participants included both short- and long-stay residents
Intervention (I)
- ACP Specialist Program, delivered by internal staff (e.g. nurses, chaplains, social workers) with dedicated time
- Includes:
- Online structured ACP training (7 modules + launch and booster module)
- Standardised tools (discussion guides, documentation templates, care planning prompts)
- Monthly identification of residents for ACP discussions (especially those with ADRD)
- Leadership engagement and implementation support via corporate “champions”
Comparison (C)
- Usual care (no ACP Specialist training, no structured ACP tools or support, no dedicated staff time)
- Control homes may be aware of the program but did not participate during the trial
Outcomes (O)
Primary outcome:
- Annual rate of hospital transfers (hospital admissions + ED visits) for residents with ADRD (measured using Medicare claims and MDS data)
Secondary outcomes:
- ACP documentation of life-sustaining treatment preferences
- Hospice enrolment during the study period
- Location of death (proportion dying in hospital)
- Configurational analysis to explore implementation factors associated with better ACP uptake (e.g. staff role, facility characteristics)
Findings Summary
(Design/Protocol Stage Only)
- The trial design is highly pragmatic, leveraging existing infrastructure in corporate-owned nursing homes, routinely collected data (EHR, MDS, Medicare claims), and internal staff-led implementation
- 137 homes were stratified and randomised (68 intervention, 69 control), with characteristics well matched across groups (see Table 1, page 18)
- A power calculation shows the study is powered to detect a 22% reduction in hospitalisation rates (IRR = 0.78)
- ACP Specialists are trained using scalable corporate LMS platforms, with monthly reporting and champion support
- A novel documentation template embedded in EHRs tracks ACP engagement, goals of care, and decision-making (see Figure 2, page 17)
This trial—APPROACHES—is one of the largest and most rigorously designed evaluations of ACP in real-world U.S. nursing home settings, especially among residents with dementia .
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