Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination.

BACKGROUND: The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS: PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS: In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS: Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.

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

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.