Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting

Abstract

Background The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. Methods In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities ( N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research’s domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). Results Implementation facilitators identified by Champions included: the intervention’s adaptable mode of presentation and minimal time burden (IC) as well as the program’s customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). Conclusions Despite the promise of PROVEN’s intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN’s implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. Trial registration ClinicalTrials.gov Identifier: NCT02612688 . Registered 19 November 2015. Electronic supplementary material The online version of this article (10.1186/s12913-019-4309-5) contains supplementary material, which is available to authorized users.

Impact of an Advance Care Planning Video Intervention on Care of Short‐Stay Nursing Home Patients

“…Earlier qualitative reports from PROVEN, found ACP champions, in NHs with low intervention fidelity noted that they had limited time to devote to offering and showing the video, particularly in facilities with high staff turnover 37 . Some champions suggested that they would prefer to use the ACP videos on an as‐needed basis to their discretion 38 . Insufficient staff time to implement a new treatment or intervention is not unique to ACP.…”

Barriers impacting the POINT pragmatic trial: the unavoidable overlap between research and intervention procedures in “real-world” research

“…The fact that the majority of barriers cut across aspects of both intervention and research implementation demonstrates the high degree to which aspects of the intervention of focus and research protocols can be intertwined within a pragmatic trial . The tension between real-world service delivery and pragmatic trial protocols has been discussed in prior literature [ 12 , 19 , 25 , 26 ]; however, these discussions have largely focused on how attention to external validity can lead to questionable implementation of the intervention and type III error (i.e., the attribution of outcomes to an intervention that was never fully implemented) [ 4 , 19 , 27 , 28 ]. Our findings demonstrate how the real-world research context can impact full implementation of both intervention and research protocols, even when protocols have been developed to accommodate the local service setting (see Table 1 ).…”

“…The inner setting where the intervention is delivered is a frequently documented barrier in implementation science and pragmatic trials [ 19 , 32 ], and aspects of the ED’s communication networks, culture, and structure were demonstrated barriers for POINT intervention and research protocols. These issues were apparent at both hospitals, but, while not captured in the interviews, they were much more difficult to address in the urban hospital site where frequent changes in leadership led to less support for the study over time.…”

“…An intention-to-treat approach is followed. a 1/very explanatory, 2/rather explanatory, 3/equally pragmatic/explanatory, 4/rather pragmatic, and 5/very pragmatic implementation within at least one pragmatic trial [19], to our knowledge, it has not been used to investigate research protocol implementation.…”

“…The CFIR comprises 37 implementation determinant constructs organized in 5 domains: inner setting, outer setting, intervention characteristics, characteristics of individuals, and the implementation process. While the CFIR has been used to investigate intervention implementation within at least one pragmatic trial [ 19 ], to our knowledge, it has not been used to investigate research protocol implementation.…”