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Table 1 PRECIS-2 domains of implementation in the PROVEN trial: approaches and challenges

From: A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems

Domaina Aspecta Approach as originally designed Challenges Approach/adaptation
Organization Personnel RT: one principal investigator and one project director on intervention team; data team created feedback reports
HCS: one corporate-level administrator and one clinical education specialist oversaw implementation; ACP champion(s) delivered intervention at NH; information technology personnel integrated VSR into EMR
• Turnover of HCS clinical education specialists
• ACP champion turnover
• Redundancy in HCS leadership roles
• Creates detailed tracking system for champions
• Regular trainings for champion replacements
Resources RT: developed videos; supplied tablet devices; created website URLs for viewing videos
HCS: provided EMR system to host VSR
• Two NHs had mostly Navajo patients
• Tablets missing at one NH
• RT created translated videos
• RT replaced missing tablets
Training RT: developed training materials
HCS: organized and provided training venues
RT and HCS: co-led trainings
• Each HCS had different preferred modalities • HCS1 webinar-based training; HCS2 group on-site training
Flexibility (delivery) Protocol-driven RT: prescribed guidelines for when to offer video; flexible guidelines for which video to offer, who shows videos, how to show (tablet vs. website URL)
HCS: ACP champions delivered intervention
• Limited control of how champion implemented protocol
• Competing champion clinical responsibilities
• HCS leaders strongly endorsed program
• Champion support and coaching
(did providers deliver the intervention per protocol?)
HCS: embedded VSR in EMR; internal bi-weekly feedback reports for VSR completion on new or re-admissions only
RT: created VSR; generated quarterly feedback reports for new or re-admissions and LTC; ACP champion qualitative interviews
RT and HCS: monthly group champion check-in calls
• Poorer delivery to LTC patients vs. new or re-admissions
• Delays and inaccuracies in RT generated reports
• VSR seen as a barrier
• Group check-in calls inefficient
• Champions retrained
• RT feedback report generated monthly
• 1:1 champion calls replace group calls
• Enrollment period extended
Co-interventions RT and HCS: other on-going initiatives to improve ACP activities and reduce hospitalizations allowed • Other ACP activities variable & not easily measured
• Hospitalization rates drop
• Questions about ACP activities inserted into champion interviews
Flexibility (adherence) Pre-screening RT and HCS: excluded NHs with major organizational or regulatory difficulties • Determination of “dysfunctional” sites was subjective
Withdrawal RT and HCS: NHs with low adherence were not dropped • No uptake in ~ 10% of NHs
• Small number of NHs divested mid-study
• Intention-to-treat analyses
(did patients/families view videos as intended?)
RT: protocol compliance initially defined as VSR completion (i.e., offering a video) vs. showing a video; analysis of VSR items able to examine whether or not video was shown when offered • Videos commonly not shown when offered
• Web-based video viewing rates could not be tracked
• Showing rates added to feedback reports
• LTC patients not shown a video identified and targeted through intense champion coaching
  1. RT  research team, HCS  health care system, LTC long-term care, NH nursing home, ACP advance care planning, EMR electronic medical record, VSR video status report
  2. aPRECIS-2 Domains and Aspects derived from Loudon et al. (2015) [6]