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A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

ABSTRACT: BACKGROUND:PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve advance care planning, is one of the first large pragmatic, cluster randomized trials within nursing home health care systems. While certain features of pragmatic trials remain static once designed (e.g., recruitment, outcomes), successful implementation of a system-wide program requires on-going evaluation and adaptation. This report's objectives were to apply PRECIS-2 in a novel manner during the actual conduct of the PROVEN trial to assess how dynamic adaptations shifted implementation to either a more explanatory or a more pragmatic approach. METHODS:We assessed PROVEN's protocol as initially designed according to the three PRECIS-2 domains pertinent to implementation: (1) Organization, (2) Flexibility-Delivery, and (3) Flexibility-Adherence. We then applied this framework to conduct a formative evaluation of decisions made while the trial was ongoing to adapt the implementation approach along the pragmatic versus the explanatory continuum in response to emergent challenges. RESULTS:Based on the PRECIS-2 rubric, the initial design of the PROVEN implementation approach reflected a hybrid of pragmatic and explanatory features. Most notably, within the Flexibility-Delivery, the trial had a relatively pragmatic approach to protocol delivery by front-line nursing home providers, balanced with a more explanatory approach to protocol monitoring enabled by the analytic capabilities of the research team. This more intensive monitoring proved critical in revealing implementation problems once the study began. Dynamic adaptations made in response to these challenges generally reflected shifts to more explanatory approaches within the Flexibility-Delivery and Flexibility-Adherence domains including ever more intensive compliance monitoring, as well as detailed coaching of front-line providers delivering the intervention by the research team. CONCLUSIONS:Pragmatic trials conducted in the nursing home setting may benefit from a more dynamic approach to implementation. Allowing fluidity between pragmatic and explanatory features may still preserve the trial's applicability to intended stakeholders' needs. PRECIS-2 provides a useful formative evaluation tool to assess these adaptations in "real-time." TRIAL REGISTRATION:US National Library of Medicine, ClinicalTrials.gov, ID: NCT02612688 . Registered on 19 November 2015.

SUBMITTER: Palmer JA

PROVIDER: S-EPMC6106941 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

Palmer Jennifer A JA Mor Vincent V Volandes Angelo E AE McCreedy Ellen E Loomer Lacey L Carter Phoebe P Dvorchak Faye F Mitchell Susan L SL

Trials 20180822 1

<h4>Background</h4>PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve adva ...[more]

PMID: 30134976

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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:ImportanceStandardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.ObjectiveTo test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.Design, setting, and participantsThe Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.InterventionsFive 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.Main outcomes and measuresTwelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.ResultsThe study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).Conclusions and relevanceThis study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.Trial registrationClinicalTrials.gov Identifier: NCT02612688.

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description: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.

Project description:Tobacco cessation after cancer diagnosis leads to better patient outcomes. However, tobacco treatment services are frequently unavailable in cancer care settings, and multilevel implementation challenges can impede uptake of new programs. The National Cancer Institute (NCI) dedicated Cancer Moonshot funding through the Cancer Center Cessation Initiative (C3I) for NCI-Designated Cancer Centers to implement or enhance the implementation of tobacco treatment services. We examined a pragmatic application of the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate tobacco treatment programs implemented within Cancer Centers funded through C3I. Using three C3I-funded Centers as examples, we describe how each RE-AIM construct was operationalized to evaluate the implementation of a wide range of cessation services (e.g., tobacco use screening, counseling, Quitline referral, pharmacotherapy) in this heterogeneous group of cancer care settings. We discuss the practical challenges encountered in assessing RE-AIM constructs in real world situations, including using the electronic health record (EHR) to aid in assessment. Reach and effectiveness evaluation required that Centers define the setting(s) where cessation services were implemented (to determine the "denominator"), enumerate the patient population, report current patient tobacco use, patient engagement in tobacco treatment, and 6-month cessation outcomes. To reduce site heterogeneity, increase data accuracy, and reduce burden, reach was frequently captured via standardized EHR enhancements that improved the identification of current smokers and tobacco treatment referrals. Effectiveness was determined by cessation outcomes (30-day point prevalence abstinence at 6-months post-engagement) assessed through a variety of data collection approaches. Adoption was measured by the characteristics and proportion of targeted cancer care settings and clinicians engaged in cessation service delivery. Implementation was assessed by examining the delivery of tobacco screening assessments and intervention components across sites, and provider-level implementation consistency. Maintenance assessments identified whether tobacco treatment services continued in the setting after implementation and documented the sustainability plan and organizational commitment to continued delivery. In sum, this paper demonstrates a pragmatic approach to using RE-AIM as an evaluation framework that yields relevant outcomes on common implementation metrics across widely differing tobacco treatment approaches and settings.

Project description:Background/aimsA significant number of people with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Advance care planning (ACP), the process of eliciting and documenting patient-centered preferences for care, is considered essential to providing high quality care for this population. Nursing homes are currently required by regulations to offer ACP to residents and families, but no training requirements exist for nursing home staff, and approaches to fulfilling this regulatory and ethical responsibility vary. As a result, residents may receive care inconsistent with their goals, such as unwanted hospitalizations. Pragmatic trials offer a way to develop and test ACP in real-world settings to increase the likelihood of adoption of sustainable best practices.MethodsThe "Aligning Patient Preferences-a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES)" project is designed to pragmatically test and evaluate a staff-led program in 137 nursing homes (68 = intervention, 69 = control) owned by two nursing home corporations. Existing nursing home staff receive standardized training and implement the ACP Specialist program under the supervision of a corporate lead. The primary trial outcome is the annual rate of hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical, or billing purposes. Configurational analysis will also be performed to identify conditions associated with implementation.ResultsPartnerships with large corporate companies enable the APPROACHES trial to rely on corporate infrastructure to roll out the intervention, with support for a corporate implementation lead who is charged with the initial introduction and ongoing support for nursing home-based ACP Specialists. These internal champions connect the project with other company priorities and use strategies familiar to nursing home leaders for the initiation of other programs. Standardized data collection across nursing homes also supports the conduct of pragmatic trials in this setting.DiscussionMany interventions to improve care in nursing homes have failed to demonstrate an impact or, if successful, maintain an impact over time. Pragmatic trials, designed to test interventions in real-world contexts that are evaluated through existing data sources collected routinely as part of clinical care, are well suited for the nursing home environment. A robust program that increases access to ACP for nursing home residents has the potential to increase goal-concordant care and is expected to reduce hospital transfers. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve the quality of care for residents with dementia.

Project description:BackgroundNursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.Methods/designCOSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.DiscussionDespite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff's knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.Trial registrationClinicalTrials.gov NCT02238652.

Project description:Background and objectivesThe Changing Talk (CHAT) communication training effectively reduces elderspeak and subsequent behavioral challenges in residents with dementia in nursing homes (NHs). As part of the pilot pragmatic clinical trial testing Changing Talk: Online Training (CHATO), a new online version, a remote implementation design, and process evaluation were developed to capture contextual factors, ensure fidelity, and determine effective implementation strategies.Research design and methodsThe Expert Recommendation for Implementing Change compilation informed this 2-phase approach to develop and test remote implementation. An Advisory Board guided the developmental phase while pilot testing used a cluster-randomized design. Data were analyzed to evaluate NH characteristics; implementation strategies used; CHATO participation, completion, and passing rates; and leadership evaluation.ResultsFive out of 7 NHs were nonprofit with above average quality ratings (M = 4.3 of 5). Staff participants (N = 237) were mostly female (90%), non-Hispanic White (91%), and nursing assistants (46%). Implementation time ranged from 54 to 86 days (M = 70.3, standard deviation [SD] = 9.3), with planning phase ranging from 11 to 29 days (M = 20.1, SD = 6.7), and training phase ranging from 35 to 58 days (M = 50.0, SD = 7.6). A range from 3 to 11 implementation strategies were used by each NH. Assigning champions, including the social worker on the implementation team, utilizing multiple mediums for reminders, giving rewards or public recognition, supporting onsite discussions, and other tailoring strategies were associated with improved outcomes. Participation ranged from 20% to 76%. Over 63% of participants completed training (N = 150) and 87% passed the posttest (N = 130). Leadership evaluations noted staff used CHATO concepts in practice and improved communication culture.Discussion and implicationsLeadership who took an active role, engaged multiple team members, and varied strategies had better outcomes. Effectiveness of the strategies will be evaluated in a national pragmatic clinical trial testing CHATO's effects on reducing behavioral and psychological symptoms in dementia care.

Dataset Information

A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

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A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

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