Here is the standardised PICO analysis for the sixtieth uploaded article:
Full Title
Understanding Implementation Fidelity in a Pragmatic Randomized Clinical Trial in the Nursing Home Setting: A Mixed-Methods Examination
Authors: Jennifer A. Palmer, Victoria A. Parker, Lacey R. Barre, Vincent Mor, et al.
Journal: Trials, 2019; 20:656
DOI: 10.1186/s13063-019-3725-5
Type of Study
Mixed-methods fidelity analysis of a pragmatic randomised controlled trial (pRCT) – the PROVEN trial
PICO Summary
Population (P)
- Residents of 119 intervention and 241 control nursing homes across two U.S. health systems
- Focused on long-stay patients with advanced dementia, COPD, or heart failure
- Champions were social workers or nurses responsible for video-based advance care planning (ACP) intervention delivery
Intervention (I)
- PROVEN (Pragmatic Trial of Video Education in Nursing Homes) intervention:
- Champions offered ACP videos (5 options, ~6–10 minutes) to residents/families
- Target: every 6 months for long-stay residents or upon clinical change
- Delivery via tablet or secure online link
- Structured video status reporting in EMR to track adherence
- Monthly feedback reports, group coaching calls, and implementation support
Comparison (C)
- Low-adherence facilities (bottom quintile of video offer rate) vs high-adherence facilities (top quintile)
- Mixed methods used to understand differences in implementation fidelity between the two cohorts
Outcomes (O)
Implementation Fidelity assessed using a modified Conceptual Framework for Implementation Fidelity (CFIF)across 6 domains:
- Intervention Complexity:
- Video platform described as simple and user-friendly across both groups (paired-convergent theme)
- Participant Responsiveness:
- High-adherence sites: families were open and receptive
- Low-adherence sites: families often showed pushback or disinterest
- Champions at high-adherence sites also demonstrated personal investment in ACP
- Recruitment:
- High-adherence sites used strategic, persuasive language to engage families
- Low-adherence champions were more tentative or reluctant to initiate conversations
- Quality of Delivery:
- High-adherence champions supplemented videos with follow-up discussions and ACP planning
- Low-adherence sites used the videos less as integrated tools
- Context:
- Low-adherence sites experienced resource limitations (e.g., time, staff turnover)
- Some already had overlapping ACP programs, leading to reduced perceived value
- Strategies to Facilitate Implementation:
- High-adherence champions praised facilitation efforts (e.g., coaching, feedback)
- Low-adherence champions expressed confusion and lack of leadership support
Findings Summary
The analysis revealed that implementation fidelity varied sharply depending on contextual and organisational factors. While the intervention was viewed as simple and acceptable, successful implementation depended on:
- Strategic recruitment and family engagement
- Champions with confidence, training, and time
- Perceived value of the video intervention
- External facilitation and feedback loops
Three core lessons emerged for future pRCTs in long-term care:
- Flexible fidelity – allow adaptation of non-core elements while preserving fidelity to core protocol
- Reciprocal facilitation – engage champions early in design and support them continuously
- Readiness assessment – use formal tools (e.g., ORCA) to evaluate organisational and individual preparedness
Conclusion
This study provides a detailed roadmap for improving implementation fidelity in real-world trials of ACP in nursing homes. Key ingredients for success include champion empowerment, leadership engagement, and structural alignment. Without these, even simple interventions like video ACP tools can fail to reach their potential.
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