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