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

ABSTRACT: 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.

SUBMITTER: Palmer JA

PROVIDER: S-EPMC6883560 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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

Palmer Jennifer A JA Parker Victoria A VA Barre Lacey R LR Mor Vincent V Volandes Angelo E AE Belanger Emmanuelle E Loomer Lacey L McCreedy Ellen E Mitchell Susan L SL

Trials 20191128 1

<h4>Background</h4>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 implem ...[more]

PMID: 31779684

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Project description:Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N?=?119 intervention/N?=?241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

Project description:INTRODUCTION:Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person's needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study. METHODS AND ANALYSIS:A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme. ETHICS AND DISSEMINATION:Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.

Project description:BackgroundImplementation fidelity assesses the degree to which an intervention is delivered as it should be. Fidelity helps to determine if the outcome(s) of an intervention are attributed to the intervention itself or to a failure of its implementation. Little is known about how fidelity impacts the intended outcome(s) and what elements or moderators can affect the fidelity trajectory over time. We exemplify the meaning of implementation fidelity with INTERCARE, a nurse-led care model that was implemented in eleven Swiss nursing homes (NHs) and showed effectiveness in reducing unplanned hospital transfers. INTERCARE comprises six core elements, including advance care planning and tools to support inter- and interprofessional communication, which were introduced with carefully developed implementation strategies.MethodsA mixed-methods convergent/triangulation design was used to investigate the influence of implementation fidelity on unplanned transfers. A fidelity questionnaire measuring the degree of fidelity to INTERCARE's core components was fielded at four time points in the participating NHs. Two-monthly meetings were conducted with NHs (September 2018-January 2020) and structured notes were used to determine moderators affecting fidelity (e.g., participant responsiveness). We used the fidelity scores and generalized linear mixed models to analyze the quantitative data. The Framework method was used for the qualitative analysis. The quantitative and qualitative findings were integrated using triangulation.ResultsA higher overall fidelity score showed a decreasing rate of unplanned hospital transfers post-intervention (OR: 0.65 (CI = 0.43-0.99), p = 0.047). A higher fidelity score to advance care planning was associated with lower unplanned transfers (OR = 0.24 (CI 0.13-0.44), p = < 0.001) and a lower fidelity score for communication tools (e.g., ISBAR) to higher rates in unplanned transfers (OR = 1.69 (CI 1.30-2.19), p = < 0.003). In-house physicians with a collaborative approach and staff's perceived need for nurses working in extended roles, were important moderators to achieve and sustain high fidelity.ConclusionImplementation fidelity is challenging to measure and report, especially in complex interventions, yet is crucial to better understand how such interventions may be tailored for scale-up. This study provides both a detailed description of how fidelity can be measured and which ingredients highly contributed to reducing unplanned NH transfers.Trial registrationThe INTERCARE study was registered at clinicaltrials.gov Protocol Record NCT03590470.

Project description: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.

Project description:BackgroundThe use of best practice guidelines (BPGs) has the potential to decrease the gap between best evidence and nursing and healthcare practices. We conducted an exploratory mixed method study to identify strategies, processes, and indicators relevant to the implementation and sustainability of two Registered Nurses' Association of Ontario (RNAO) BPGs at Best Practice Spotlight Organizations® (BPSOs).MethodsOur study had four phases. In Phase 1, we triangulated two qualitative studies: a) secondary analysis of 126 narrative reports detailing implementation progress from 21 BPSOs spanning four sectors to identify strategies and processes used to support the implementation and sustainability of BPGs and b) interviews with 25 guideline implementers to identify additional strategies and processes. In Phase 2, we evaluated correlations between strategies and processes identified from the narrative reports and one process and one outcome indicator for each of the guideline. In Phase 3, the results from Phases 1 and 2 informed indicator development, led by an expert panel. In Phase 4, the indicators were assessed internally by RNAO staff and externally by Ontario Health Teams. A survey was used to validate proposed indicators to determine relevance, feasibility, readability, and usability with knowledge users and BPSO leaders.ResultsTriangulation of the two qualitative studies revealed 46 codes of implementation and sustainability of BPGs, classified into eight overarching themes: Stakeholder Engagement, Practice Interventions, Capacity Building, Evidence-Based Culture, Leadership, Evaluation & Monitoring, Communication, and Governance. A total of 28 structure, process, or outcome indicators were developed. End users and BPSO leaders were agreeable with the indicators according to the validation survey.ConclusionsMany processes and strategies can influence the implementation and sustainability of BPGs at BPSOs. We have developed indicators that can help BPSOs promote evidence-informed practice implementation of BPGs.

Project description:BackgroundFrail older patients are at risk of experiencing a decline in physical and cognitive function unrelated to the reason for admission. The Elder-Friendly Care (EFC) program was designed to improve the care, experiences, and outcomes of frail older adults. The project supported 8 Early Adoption Sites (EAS) in a large Canadian healthcare organization by providing multiple strategies, educational opportunities, and resources. The purpose of this study was to assess the usefulness of EFC educational materials and resources, staff practice changes and perceptions in pilot sites, and readiness for scale and spread.MethodsThe study was conducted from May 2017 to June 2018 using a mixed-methods approach incorporating the Kirkpatrick Model of Training/Evaluation. A total of 76 Direct Care Staff participated in the staff survey, which assessed their awareness of, satisfaction with, and utilization of EFC principles, resources, and practices. Additionally, 12 interviews were conducted with staff who were directly involved in site implementation of EFC.ResultsMost survey participants were aware (86%, n = 63) of the EFC program, and 85% (n = 41) indicated they or their site/unit had implemented EFC. Out of these 41 participants, the most common practice changes identified were: incorporating alternatives to restraint (81%, n = 33), decreased use of pharmacological restraint (78%, n = 32), and patient and family care planning (76%, n = 31). Participants that attended all 3 EFC Learning Workshops (LWs) were significantly more likely to recommend the EFC Toolkit to others (87% versus 40%; χ2 = 8.82, p < 0.01) compared to participants attending less than 3 EFC LWs. Interview participants indicated that the program was well structured and flexible as sites/units could adopt changes that suited their individual sites, needs, contexts, and challenges.ConclusionsThe educational materials and resources used for the EFC project are useful and appreciated by the Direct Care Staff. Further, participants perceive the EFC intervention as effective in creating positive practice change and useful in reducing hospital-related complications for older patients. Future implementation will investigate the impact of EFC on system-level outcomes in acute care.

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

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

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