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.
Bibliographical noteFunding Information:
This work is supported by the National Institutes of Health (NIH) Common Fund, through a cooperative agreement (NIH-NIA UH3AG49619) from the Office of Strategic Coordination within the Office of the NIH Director. The NIH played no role in the study design, nor in the collection and analysis and interpretation of data, nor in the writing of the manuscript. The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. Dr. Palmer is supported by NIH-NIA T32AG023480; Dr. McCreedy is supported by AHRQ National Research Service Award 4T32HS000011; Ms. Loomer is supported by NIH-NIA National Research Service Award 2T32AG023482–13; and Dr. Mitchell is supported by NIH-NIA K24AG033640.
- Nursing homes
- Pragmatic trial