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      Using Palliative Leaders in Facilities to Transform Care for People with Alzheimer’s Disease (UPLIFT-AD): protocol of a palliative care clinical trial in nursing homes

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          Abstract

          Background

          Palliative care is an effective model of care focused on maximizing quality of life and relieving the suffering of people with serious illnesses, including dementia. Evidence shows that many people receiving care in nursing homes are eligible for and would benefit from palliative care services. Yet, palliative care is not consistently available in nursing home settings. There is a need to test pragmatic strategies to implement palliative care programs in nursing homes.

          Methods/design

          The UPLIFT-AD (Utilizing Palliative Leaders in Facilities to Transform care for people with Alzheimer’s Disease) study is a pragmatic stepped wedge trial in 16 nursing homes in Maryland and Indiana, testing the effectiveness of the intervention while assessing its implementation. The proposed intervention is a palliative care program, including 1) training at least two facility staff as Palliative Care Leads, 2) training for all staff in general principles of palliative care, 3) structured screening for palliative care needs, and 4) on-site specialty palliative care consultations for a one-year intervention period. All residents with at least moderate cognitive impairment, present in the facility for at least 30 days, and not on hospice at baseline are considered eligible. Opt-out consent is obtained from legal decision-makers. Outcome assessments measuring symptoms and quality of care are obtained from staff and family proxy respondents at four time points: pre-implementation (baseline), six months after implementation, at 12 months (conclusion of implementation), and six months after the end of implementation. Palliative care attitudes and practices are assessed through surveys of frontline nursing home staff both pre- and post-implementation. Qualitative and quantitative implementation data, including fidelity assessments and interviews with Palliative Care Leads, are also collected. The study will follow the Declaration of Helsinki.

          Discussion

          This trial assesses the implementation and effectiveness of a robust palliative care intervention for residents with moderate-to-advanced cognitive impairment in 16 diverse nursing homes. The intervention represents an innovative, pragmatic approach that includes both internal capacity-building of frontline nursing home staff, and support from external palliative care specialty consultants.

          Trial registration

          The project is registered on ClinicalTrials.gov: NCT04520698.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12904-023-01226-0.

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          Most cited references39

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          A power primer.

          One possible reason for the continued neglect of statistical power analysis in research in the behavioral sciences is the inaccessibility of or difficulty with the standard material. A convenient, although not comprehensive, presentation of required sample sizes is provided here. Effect-size indexes and conventional values for these are given for operationally defined small, medium, and large effects. The sample sizes necessary for .80 power to detect effects at these levels are tabled for eight standard statistical tests: (a) the difference between independent means, (b) the significance of a product-moment correlation, (c) the difference between independent rs, (d) the sign test, (e) the difference between independent proportions, (f) chi-square tests for goodness of fit and contingency tables, (g) one-way analysis of variance, and (h) the significance of a multiple or multiple partial correlation.
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            Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

            This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.
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              RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review

              The RE-AIM planning and evaluation framework was conceptualized two decades ago. As one of the most frequently applied implementation frameworks, RE-AIM has now been cited in over 2,800 publications. This paper describes the application and evolution of RE-AIM as well as lessons learned from its use. RE-AIM has been applied most often in public health and health behavior change research, but increasingly in more diverse content areas and within clinical, community, and corporate settings. We discuss challenges of using RE-AIM while encouraging a more pragmatic use of key dimensions rather than comprehensive applications of all elements. Current foci of RE-AIM include increasing the emphasis on cost and adaptations to programs and expanding the use of qualitative methods to understand “how” and “why” results came about. The framework will continue to evolve to focus on contextual and explanatory factors related to RE-AIM outcomes, package RE-AIM for use by non-researchers, and integrate RE-AIM with other pragmatic and reporting frameworks.
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                Author and article information

                Contributors
                kunroe@iu.edu
                Journal
                BMC Palliat Care
                BMC Palliat Care
                BMC Palliative Care
                BioMed Central (London )
                1472-684X
                26 July 2023
                26 July 2023
                2023
                : 22
                : 105
                Affiliations
                [1 ]GRID grid.257413.6, ISNI 0000 0001 2287 3919, Indiana University School of Medicine, ; Indianapolis, IN 46202 USA
                [2 ]GRID grid.448342.d, ISNI 0000 0001 2287 2027, Regenstrief Institute, Inc, ; Indianapolis, IN 46202 USA
                [3 ]GRID grid.25879.31, ISNI 0000 0004 1936 8972, University of Pennsylvania School of Nursing, ; Philadelphia, PA 19104 USA
                [4 ]GRID grid.257413.6, ISNI 0000 0001 2287 3919, Department of Biostatistics, , Indiana University, ; Indianapolis, IN 46202 USA
                [5 ]GRID grid.411024.2, ISNI 0000 0001 2175 4264, University of Maryland School of Social Work, ; Baltimore, MD 21201 USA
                Article
                1226
                10.1186/s12904-023-01226-0
                10369841
                8b842711-2b38-40af-8b9e-f21433ca8a29
                © The Author(s) 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 30 June 2023
                : 12 July 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000049, National Institute on Aging;
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award ID: R01 AG066922
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2023

                Anesthesiology & Pain management
                nursing home,palliative care,dementia
                Anesthesiology & Pain management
                nursing home, palliative care, dementia

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