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Pragmatic Trials and Improving Long-Term Care: Recommendations From a National Institutes of Health Conference

      Conducting clinical trials in nursing homes, assisted living, and other long-term settings is attendant with challenges, including but not limited to recruitment and retention of settings, participant attrition, staff time constraints, family resistance, research ethics concerns, burdensome implementation and measurement, cost, and mistrust.
      • Lam H.R.
      • Chow S.
      • Taylor K.
      • et al.
      Challenges of conducting research in long-term care facilities: a systematic review.
      • Öhman H.
      • Savikko N.
      • Strandberg T.E.
      • et al.
      Effects of exercise on cognition: the Finnish Alzheimer disease exercise trial: a randomized, controlled trial.
      • Raglio A.
      • Bellandi D.
      • Baiardi P.
      • et al.
      Effect of active music therapy and individualized listening to music on dementia: a multicenter randomized controlled trial.
      • Chen C.L.H.
      • Lu Q.
      • Moorakonda R.B.
      • et al.
      Alzheimer’s disease THErapy with NEuroaid (ATHENE): A randomized double-blind delayed-start trial.
      • Torres-Castro S.
      • Rabaneda-Bueno R.
      • Lopez-Ortega M.
      • Gutierrez-Robledo
      • Guzman A.
      Multi-component staff training intervention to improve residential dementia care (PROCUIDA-Demencia): a mixed-methods two-arm cluster randomised controlled pilot and clinical outcomes study.
      • Konya I.
      • Iwata H.
      • Hayashi M.
      • et al.
      Effectiveness of weak wiping pressure during bed baths in hospitalized older adults: a single-blind randomized crossover trial.
      • Kane R.L.
      • Huckfeldt P.
      • Tappen R.
      • et al.
      Effects of an intervention to reduce hospitalizations from nursing homes: a randomized implementation trial of the INTERACT program.
      For these reasons and also because research protocols may dictate exclusionary eligibility criteria, participation rates may be low, data may be incomplete, and results may not be generalizable.
      • Lathren C.
      • Sheffield-Abdullah K.
      • Sloane P.D.
      • et al.
      Certified nursing assistants' experiences with self-compassion training in the nursing home setting.
      • Gaugler J.E.
      • Roth D.L.
      • Haley W.E.
      • Mittelman M.S.
      Can counseling and support reduce burden and depressive symptoms in caregivers of people with Alzheimer's disease during the transition to institutionalization? Results from the New York University caregiver intervention study.
      • Huizing A.R.
      • Hamers J.P.
      • Gulpers M.J.
      • Berger M.P.
      A cluster-randomized trial of an educational intervention to reduce the use of physical restraints with psychogeriatric nursing home residents.
      • Lee E.L.
      • Shin M.J.
      • Myoung K.K.
      • et al.
      The effect of IT convergence gamification training in community-dwelling older people: a multicenter, randomized controlled trial (RCT) study.
      • Rutten J.J.S.
      • van Buul L.W.
      • Smalbrugge M.
      • et al.
      An electronic health record integrated decision tool and supportive interventions to improve antibiotic prescribing for urinary tract infections in nursing homes: a cluster randomized controlled trial.
      • Boxer R.S.
      • Dolansky M.
      • Chaussee E.
      • et al.
      A randomized controlled trial of heart failure disease management versus usual care in skilled nursing facilities.
      • Weerahandi H.
      • Chaussee E.L.
      • Dodson J.A.
      • Dolansky M.
      • Boxer R.S.
      Disease management in skilled nursing facilities improves outcomes for patients with a primary diagnosis of heart failure.
      • Park J.
      • McCaffrey R.
      • Newman D.
      • Liehr P.
      • Ouslander J.G.
      A pilot randomized controlled trial of the effects of chair yoga on pain and physical function among community-dwelling older adults with lower extremity osteoarthritis.
      Recognition of these challenges catalyzed a recent initiative to develop recommendations for a nursing home clinical trials network.
      • Gurwitz J.H.
      • Quinn C.C.
      • Abi-Elia I.H.
      • et al.
      Advancing clinical trials in nursing homes: a proposed roadmap to success.
      A key limitation of all such trials, however, is the extent to which they ultimately change practice and policy and improve care and outcomes, especially for persons living with dementia; for that purpose, pragmatic trials are recommended. First articulated more than 50 years ago, a pragmatic approach determines an intervention’s effectiveness in routine clinical practice.
      • Schwartz D.
      • Lellouch J.
      Explanatory and pragmatic attitudes in therapeutical trials.
      Pragmatism applies to recruitment (extent to which settings and participants are similar to those in usual care, and extent of effort required for recruitment); the intervention itself and its delivery (availability of resources in standard care, flexibility and ease of implementation, encouragement, and monitoring); the nature of follow-up (reasonable intensity); and the nature, determination, and analysis of outcomes (extent to which outcomes are relevant to participants).
      • Thorpe K.E.
      • Zwarenstein M.
      • Oxman A.D.
      • et al.
      A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers.
      ,
      • Ford I.
      • Norrie J.
      Pragmatic trials.
      Pragmatic trials are especially important in long-term care, because limitations in care and resulting outcomes have been long noted. As but a sampling of issues, almost 60% of adverse events among nursing home residents are potentially avoidable, and the majority result in hospitalization.
      US Department of Health and Human Services Office of Inspector General
      Adverse events in skilled nursing facilities: national incidence among Medicare beneficiaries.
      Likewise, in assisted living, the error rate of medication administration exceeds 20%, and more than 40% of residents have unmet care needs.
      • Zimmerman S.
      • Love K.
      • Sloane P.D.
      • et al.
      Medication administration errors in assisted living: scope, characteristics, and the importance of staff training.
      • Young H.M.
      • Gray S.L.
      • McCormick W.C.
      • et al.
      Types, prevalence, and potential clinical significance of medication administration errors in assisted living.
      • Freedman V.A.
      • Spillman B.C.
      The residential continuum from home to nursing home: size, characteristics and unmet needs of older adults.
      Specific to long-term care residents with dementia, unmet needs include care for pain management, visual limitations/sensory issues, activities of daily living, social engagement, support with grief and loss, and end-of-life care.
      • Koch J.M.
      • Datta C.
      • Makhdoom S.
      • Grossberg G.T.
      Unmet visual needs of Alzheimer’s disease patients in long-term care facilities.
      • Cadieux M.A.
      • Garcia L.J.
      • Patrick J.
      Needs of people with dementia in long-term care: a systematic review.
      • Shiells K.
      • Pivodic L.
      • Holmerová I.
      • Van den Block L.
      Self-reported needs and experiences of people with dementia living in nursing homes: a scoping review.
      • Zimmerman S.
      • Sloane P.D.
      • Ward K.
      • et al.
      Effectiveness of a mouth care program provided by nursing home staff vs standard care on reducing pneumonia incidence: a cluster randomized trial.
      Countless interventions have been conducted to address these and other care needs, but few have been implemented in real world settings, hence the need for pragmatic trials of promising practices.
      Pragmatic trials are not without their own challenges, however. It may be challenging to recruit organizations that are underperforming, and so eligibility may be restricted and participating organizations may not be generalizable; the proposed intervention may not be consistent with the goals of the organization; requirements to obtain informed consent may be anything but pragmatic; resource needs may exceed capacity; data requirements may not be consistent with standard care; obtaining clinician and staff involvement may be problematic; and maintenance of new care practices may be limited.
      • Zimmerman S.
      • Sloane P.D.
      Making pragmatic trials pragmatic in post-acute and long-term care settings.
      • Moyo P.
      • Loomer L.
      • Teno J.
      • et al.
      Effect of a video-assisted advance care planning intervention on end-of-life health care transitions among long-stay nursing home residents.
      • Sloane P.D.
      • Zimmerman S.
      • Ward K.
      • et al.
      A 2-year pragmatic trial of antibiotic stewardship in 27 community nursing homes.
      • Resnick B.
      • Boltz M.
      • Galik E.
      • et al.
      Testing the implementation of function-focused care in assisted living settings.
      • Zimmerman S.
      • Wretman C.J.
      • Ward K.
      • et al.
      Fidelity and sustainability of Mouth Care Without a Battle and lessons for other innovations in care.
      • Magid K.H.
      • Galenbeck E.
      • Levy C.
      How pragmatic are trials in nursing home settings?.
      Recognizing the critical importance of pragmatic trials in long-term care, the National Institute on Aging (NIA) funded a 2021 conference to convene diverse experts to identify priorities and best practices for pragmatic trials in long-term care, with a focus on care for persons with dementia. Experts included international clinical and health service researchers, directors of nursing home and assisted living organizations, and directors and presidents of professional and advocacy organizations (see acknowledgements for a list of experts and their affiliations). This editorial presents summative recommendations from that conference; one other article presents research challenges and potential solutions, and another presents implementation and dissemination challenges and opportunities, all of which inform these recommendations.
      • Resnick B.
      • Zimmerman S.
      • Gaugler J.
      • et al.
      Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
      ,
      • Levy C.
      • Zimmerman S.
      • Mor V.
      • et al.
      Pragmatic trials in long-term care: implementation and dissemination challenges and opportunities.
      Importantly, the recommendations aim to not only facilitate the conduct of pragmatic trials in long-term care but also to achieve widespread evidence-based change in long-term care practice and policy.

      Recommendations for Pragmatic Trials in Long-Term Care Designed to Achieve Widespread Change

      The 12 recommendations emanating from the conference address 4 interrelated areas: revamp the academic mindset and enterprise, respond to what is known about content and process, reframe the partnership paradigm, and reach 3 key parties toward 3 key goals when communicating (see Table 1).
      • 1.
        Revamp the Academic Mindset and Enterprise
      Table 1Recommendations to Improve Pragmatic Trials and Achieve Evidence-Based Change in Long-Term Care Practice and Policy: Revamp, Respond, Reframe, Reach
      1. Revamp the academic mindset and enterprise
       • Develop practice-based evidence
       • Change the academic mindset and academic process to one of quality improvement
       • Maximize nimble funding opportunities
      2. Respond to what is known about content and process
       • Draw from existing knowledge regarding the topic in the context of implementation
       • Think systemically when implementing a new intervention
       • Build the knowledge base related to the topic in the context of implementation
      3. Reframe the partnership paradigm
       • Be purposeful in identifying partners
       • Begin the collaboration before the proposal is written
       • Collaborate to change care practices that are not pragmatic
      4. Reach 3 key parties toward 3 key goals when communicating
       • Communicate to organizations to change care
       • Communicate to the public to drive awareness and create urgency
       • Communicate to academics to promote science
      Two of the more compelling recommendations from the experts are the need to turn the “evidence-based research” mindset 180 degrees, and advocate for changes in the research enterprise; a third recommendation is to promote and capitalize on nimble funding opportunities.
      • Develop practice-based evidence. Ultimately, the most pragmatic efforts are those that are already in practice, thereby proving that they meet the sine qua non of pragmatism. As a case in point, developing practice-based evidence is how the evidence for small model Green House nursing homes has been and is being built. The first Green House home opened in 2003 as an alternative to traditional “institutional” care; today there are 362 Green House homes in 32 states, with homes in development in 4 additional states. Research on Green House homes has created evidence of benefits (eg, for hospital readmissions and some quality measures) and also challenges (eg, variability in implementation); this evidence is being used to modify the practice-based model.
        • Zimmerman S.
        • Bowers B.J.
        • Cohen L.W.
        • et al.
        New evidence on the green house model of nursing home care: synthesis of findings and implications for policy, practice, and research.
      • Change the academic mindset and academic process to one of quality improvement. The organizational leaders were especially concerned that the academic mindset and related processes interfere with the research they themselves find most useful. Even for a pragmatic trial, institutional review boards (IRBs) may disallow or overly complicate processes that are standard care—such as talking with a family member shortly after the death of a resident or evaluating a new care practice without having to develop intricate clinical trials protocols. Instead, the mindset of quality improvement may be more fruitful and more likely to achieve actual practice and policy change and is already incorporated into nursing home care in the context of ongoing quality assurance and performance improvement (QAPI) for which numerous resources are readily available.
        Centers for Medicare & Medicaid Services
        QAPI at a glance.
        Research that helps guide and evaluate QAPI initiatives may avoid restrictive academic processes, ensure a focus on topics that are embraced by the organization, and ideally achieve sustainability of new care practices.
      • Maximize nimble funding opportunities. Long-term care providers are often well aware of their own need for research and evidence, but even with a research partner, a critical challenge is that most funding opportunities entail a lengthy process of proposal development, review, and resubmission, with funding beginning years later. By the time the project is ultimately completed, the provider may no longer be invested in the initial topic. Countless rapid response grant funding opportunities made available during the COVID-19 pandemic prove that more responsive strategies are feasible and can serve as a model for the future. In addition, existing opportunities, such as the NIA Imbedded Pragmatic Alzheimer’s Disease and AD-Related Dementias Clinical Trials Collaboratory (NIA IMPACT Collaboratory), allow a shorter timeline and provide support to promote funding success.
        NIA IMPACT Collaboratory
        Transforming dementia care.
      • 2.
        Respond to What Is Known About Content and Process
      Notwithstanding the preceding points about taking the lead from the organization when determining what to study, there is need to be informed by the evidence.
      • Draw from existing knowledge regarding the topic in the context of implementation. Based on strong efficacy studies, there is an abundance of literature on promising interventions to improve care and outcomes across numerous areas—although specific to persons with dementia, evidence of efficacy for interventions to address agitation and aggression is insufficient.
        • Jutkowitz E.
        • Brasure M.
        • Fuchs E.
        • et al.
        Care-delivery interventions to manage agitation and aggression in dementia nursing home and assisted living residents: a systematic review and meta-analysis.
        • Zimmerman S.
        • Anderson W.L.
        • Brode S.
        • et al.
        Systematic review: effective characteristics of nursing homes and other residential long-term care settings for people with dementia.
        • Scales K.
        • Zimmerman S.
        • Miller S.J.
        Evidence-based nonpharmacological practices to address behavioral and psychological symptoms of dementia.
        At the same time, there is growing literature on challenges related to implementation of pragmatic trials and quality improvement projects, including but not limited to identifying outcome measures that are relevant to residents and their families while being practical to collect, fidelity to the intervention while allowing flexibility in delivery without affecting the “secret sauce” of what is necessary to achieve outcomes, the variable nature of long-term care organizations, and lack of ultimate change in the overall culture of care.
        • Resnick B.
        • Zimmerman S.
        • Gaugler J.
        • et al.
        Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
        ,
        • Mitchell S.L.
        • Volandes A.E.
        • Gutman R.
        • et al.
        Advance care planning video intervention among long-stay nursing home residents: a pragmatic cluster randomized clinical trial.
        ,
        • Abraham J.
        • Kupfer R.
        • Behncke A.
        • et al.
        Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial.
        Evidence regarding the “what” and the “how” can and should be better integrated, such that, for example, a trial on advance care planning is informed not only by evidence on advance care planning itself but also by evidence specific to implementation of advance care planning in long-term care. Based on the conference proceedings, the article by Resnick and colleagues summarizes numerous future areas for suggested implementation research on functional care and outcomes, psychosocial care and quality of life, and medical care and outcomes.
        • Resnick B.
        • Zimmerman S.
        • Gaugler J.
        • et al.
        Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
      • Think systemically when implementing a new intervention. Long-term care organizations are complex adaptive systems.
        • Pype P.
        • Mertens F.
        • Helewaut F.
        • et al.
        Healthcare teams as complex adaptive systems: understanding team behaviour through team members’ perception of interpersonal interaction.
        As such, care processes and interpersonal interactions are dynamic, and any one component may affect and be affected by another. There is evidence, for example, that relinquishing top-down management may be important to change care,
        • Anderson R.A.
        • Issel L.M.
        • McDaniel R.R.
        Nursing homes as complex adaptive systems: relationship between management practice and resident outcomes.
        and that different strategies may be important to change practices in assisted living vs nursing homes.
        • Zimmerman S.
        • Mitchell C.M.
        • Beeber A.
        • et al.
        Strategies to reduce potentially inappropriate antibiotic prescribing in assisted living and nursing homes. Agency for Healthcare Research and Quality.
        Thus, it may be necessary to deimplement an established practice so as to implement a new practice and achieve desired outcomes, but the linkage between the two may not be clear. Further, processes to maximize sustainability after the completion of a trial are paramount, because unless the organization has fully incorporated new practices as standard care, there is good chance that care will revert to previous processes after the trial.
      • Build the knowledge base related to the topic in the context of implementation. Given the need to effect change in long-term care, it is recommended that pragmatic trials themselves further inform implementation. Two models are especially useful toward this end. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS and PRECIS-2) provides a framework to critically evaluate processes related to recruitment (eg, eligibility, effort, representativeness), the intervention in the context of the organization (eg, available resources, flexibility in delivery and adherence), follow-up (eg, intensity of data collection and monitoring), and outcomes (eg, relevance, intent to treat analyses).
        • Thorpe K.E.
        • Zwarenstein M.
        • Oxman A.D.
        • et al.
        A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers.
        ,
        • Ford I.
        • Norrie J.
        Pragmatic trials.
        ,
        • Loudon K.
        • Treweek S.
        • Sullivan F.
        • et al.
        The PRECIS-2 tool: designing trials that are fit for purpose.
        The Readiness Assessment for Pragmatic Trials (RAPT) model reframes these considerations in the context of the extent to which a trial is actually ready for implementation considering how detailed the implementation protocol is, whether evidence supports efficacy, issues regarding risk and safety, feasibility, available measures, cost, acceptability to the organization and the extent to which it aligns with their priorities, and anticipated impact.
        • Baier R.R.
        • Jutkowitz E.
        • Mitchell S.L.
        • McCreedy E.
        • Mor V.
        Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial.
        It is recommended that pragmatic trials not only be informed by the components of these models but also further inform them.
      • 3.
        Reframe the Partnership Paradigm
      The importance of research partnerships has been long-recognized in community-based research/community-based participatory research, including in nursing homes and assisted living.
      • Viswanathan M.
      • Ammerman A.
      • Eng E.
      • et al.
      Community-based participatory research: assessing the evidence: summary. 2004 Aug. In: AHRQ Evidence Report Summaries. Agency for Healthcare Research and Quality (US); 1998-2005:99.
      • Van Malderen L.
      • De Vriendt P.
      • Mets T.
      • Verté D.
      • Gorus E.
      Experiences and effects of structurally involving residents in the nursing home by means of participatory action research: a mixed method study.
      • Love K.
      • Zimmerman S.
      • Cohen L.
      the CEAL-UNC Collaborative
      A manual for community-based participatory research: using research to improve practice and inform policy in assisted living.
      However, conference participants noted numerous shortcomings in terms of how truly partnered the long-term care staff, residents, and families are in the research enterprise. As such, 3 recommendations are set forth.
      • Be purposeful in identifying partners. Perhaps the most important criteria when identifying partners are that the long-term care organization is motivated to change and has the capacity to implement the trial or quality improvement project with fidelity. Such an organization might be willing to redesign jobs and modify performance evaluations and record keeping systems. Unfortunately, these criteria may be at odds with the capacity of poorer performing settings that are most in need of change; if those organizations are excluded, inequity in access may result.
        • Levy C.
        • Zimmerman S.
        • Mor V.
        • et al.
        Pragmatic trials in long-term care: implementation and dissemination challenges and opportunities.
        One strategy to reconcile this challenge would be to have a sample sufficient enough to achieve likely fidelity while also including organizations less likely to be successful—recognizing that inclusion of the latter may inform pragmatism so as to more successfully involve them going forward. Furthermore, if the research design can stratify such low-resource organizations into intervention and control conditions, it may be reasonable to provide differential implementation support to those providers in acknowledgement of their preexisting disadvantage.
      • Begin the collaboration before the proposal is written. Although the partners themselves know best what is pragmatic for their organization, what care processes can be conducted with fidelity, and the required timeline for implementation, organizational leaders noted that they are rarely involved when the proposal is at its most formative stage. Consequently, it is critical that the research team reach out to partners while the proposal, and particularly the intervention to be implemented, are still highly formative, and be prepared to pivot. At the same time, it is necessary that a priori, the research team not be naïve to the organization’s mission, practices, and challenges; if necessary, it may be advisable to seek consultation before reaching out to potential partners.
      • Collaborate to change care practices that are not pragmatic. Just as it is recommended to change the academic mindset, so too is there cause to change the organizational mindset. One recommendation that is gaining traction is for research consent to be integrated into clinical consent at the time of admission into a long-term care setting, so that deidentified information from existing records may be used without need to obtain additional time-intense consent.
        • Resnick B.
        • Zimmerman S.
        • Gaugler J.
        • et al.
        Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
        Doing so would also allow for the inclusion of a greater number of residents vs the few who might be approachable and able to consent to a research study. Of note, the National Institutes of Health (NIH) Common Rule allows for waiver of consent for information extracted from medical records without identifiers. Participation in trials in which there is some potential for risk requires individual consent, but interventions such as those that might be introduced as quality improvement projects may allow waiver of consent. An additional area in which care practices may be changed so as to be more pragmatic is to have electronic health records that may be modified/adapted to include select new information, which could benefit medical care as well.
        • Weir C.R.
        • Staggers N.
        • Gibson B.
        • et al.
        A qualitative evaluation of the crucial attributes of contextual information necessary in EHR design to support patient-centered medical home care.
      • 4.
        Reach 3 Key Parties Toward 3 Key Goals When Communicating
      Communication is relevant throughout a pragmatic trial and quality improvement project, but standard communication practices often fail to achieve the desired intent. Toward that end, it is helpful to clarify the intended audience and related purpose and modes of communication.
      • Communicate to organizations to change care. Messaging matters at all levels of the organization. Related to direct care workers, one organizational leader commented that the term research—and by extension, pragmatic or any other type of trial—translates to care providers as more work; absent motivating factors and reframing, the opportunity to participate in research is not typically met with enthusiasm. At the other end of the spectrum, although C-suite executives—including chief executive, financial, operating, and information officers—are motivated to change practices and engage in data-driven partnerships,
        McKnights Long-Term Care News
        Data-driven partnerships.
        ,
        McKnights Long-Term Care News
        Holleran research firm adds business analytics, community metrics.
        research results rarely come to their attention, in large part because research findings are published in academic journals. That said, translating materials and providing them passively through conference presentations or unsolicited mailings as an alternate venue for communication is largely ineffective in changing care practices, whereas social influencing interventions and promotion by opinion leaders and social media are more effective.
        • Oxman A.D.
        • Thomson M.A.
        • Davis D.A.
        • et al.
        No magic bullets: a systematic review of 102 trials of interventions to improve professional practice.
        ,
        Why is Social Media Important to Researchers?.
        If a pragmatic trial is to change care, dissemination must reach the end user; use of dissemination planning tools even before the research begins may be helpful toward this end.
        • Carpenter D.
        • Nieva V.
        • Albaghal T.
        • Sorra J.
        Development of a planning tool to guide research.
      • Communicate to the public to drive awareness and create urgency. Setting politics aside, health care practice and policy changed in a heartbeat in response to COVID-19. Although raising awareness does not in and of itself create change, there is little impetus for change absent awareness. Partnering communication efforts with advocacy and provider organizations such as the Alzheimer’s Association and the American Health Care Association, and with professional organizations such as the Society for Post-Acute and Long-Term Care Medicine, the American Geriatrics Society, the Gerontological Advanced Practice Nurses Association, and others, can promote awareness through their own websites and national education campaigns. For example, the Alzheimer’s Association’s Facts and Figures Report and the American Geriatrics Society website HealthinAging.org share information widely with the public.
        Alzheimer’s Association
        2021 Alzheimer’s disease facts and figures.
        ,
        2021 Alzheimer’s disease facts and figures. Special report: race, ethnicity and Alzheimer’s in America. HealthinAging.org.
        Also, researchers who intend to change practice and policy are advised to share their work with the lay press as a matter of course, lest its importance not come to common knowledge.
      • Communicate to academics to promote science. The most important messaging to other academics in the context of pragmatic trials are the related successes and failures. If an efficacious practice was widely effective or ineffective, it promotes others’ trials to understand what made the trial successful, less successful, or unsuccessful; the PRECIS-2 and RAPT provide useful terminology toward his end.
        • Thorpe K.E.
        • Zwarenstein M.
        • Oxman A.D.
        • et al.
        A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers.
        ,
        • Loudon K.
        • Treweek S.
        • Sullivan F.
        • et al.
        The PRECIS-2 tool: designing trials that are fit for purpose.
        ,
        • Baier R.R.
        • Jutkowitz E.
        • Mitchell S.L.
        • McCreedy E.
        • Mor V.
        Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial.
        For example, the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) evidenced low fidelity because the videos were not integrated into work flow, and Mouth Care Without a Battle was successful over 1 year but not over 2 years because sustainability was challenging.
        • Zimmerman S.
        • Sloane P.D.
        • Ward K.
        • et al.
        Effectiveness of a mouth care program provided by nursing home staff vs standard care on reducing pneumonia incidence: a cluster randomized trial.
        ,
        • Mitchell S.L.
        • Volandes A.E.
        • Gutman R.
        • et al.
        Advance care planning video intervention among long-stay nursing home residents: a pragmatic cluster randomized clinical trial.
        In sharing information related to implementation, future success is more likely.
        • Colón-Emeric C.
        • Toles M.
        • Cary Jr., M.P.
        • et al.
        Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers.

      Next Steps for Pragmatic Trials in Long-Term Care and Achieving Widespread Change

      The 12 recommendations presented herein—in addition to the research, implementation, and dissemination challenges, opportunities, and solutions discussed in the other 2 conference proceeding articles
      • Resnick B.
      • Zimmerman S.
      • Gaugler J.
      • et al.
      Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
      ,
      • Levy C.
      • Zimmerman S.
      • Mor V.
      • et al.
      Pragmatic trials in long-term care: implementation and dissemination challenges and opportunities.
      —are intended to not only promote the conduct of pragmatic trials in long-term care but also to achieve widespread change in practice and policy. Although pragmatic trials are not a panacea to improve care and outcomes, if the issues related to their successful conduct were fully addressed, there is cause to believe that recommendations related to revamping the academic mindset and enterprise, responding to what is known about content and process, reframing the partnership paradigm, and reaching key partners toward key goals when communicating, can go a long way toward that end.

      Acknowledgments

      The authors thank the following conference presenters for their insights that are reflected in these recommendations: Kathleen Abrahamson (Purdue University), Nicole Brandt (University of Maryland), Cathleen Colón-Emeric (Duke University), Elizabeth Galik (University of Maryland), David Gifford (American Health Care Association), Stefan Gravenstein (Brown University), Sherry Greenberg (Gerontological Advanced Practice Nurses Association), Laura Hanson (University of North Carolina), Juliet Holt Klinger (Brookdale Senior Living), Cathy Lieblich (Pioneer Network), Sunny Linnebur (American Geriatrics Society), Angie McAllister (Signature HealthCARE), Lona Mody (University of Michigan and VA Ann Arbor Healthcare System), Arif Nazir (Society for Post-Acute and Long-Term Care Medicine), Douglas Pace (Alzheimer’s Association), Robyn Stone (LeadingAge), Kathleen Unroe (Indiana University), and Hilde Verbeek (Maastricht University).

      References

        • Lam H.R.
        • Chow S.
        • Taylor K.
        • et al.
        Challenges of conducting research in long-term care facilities: a systematic review.
        BMC Geriatr. 2018; 18: 242
        • Öhman H.
        • Savikko N.
        • Strandberg T.E.
        • et al.
        Effects of exercise on cognition: the Finnish Alzheimer disease exercise trial: a randomized, controlled trial.
        J Am Geriatr Soc. 2016; 64: 731-738
        • Raglio A.
        • Bellandi D.
        • Baiardi P.
        • et al.
        Effect of active music therapy and individualized listening to music on dementia: a multicenter randomized controlled trial.
        J Am Geriatr Soc. 2015; 63: 1534-1539
        • Chen C.L.H.
        • Lu Q.
        • Moorakonda R.B.
        • et al.
        Alzheimer’s disease THErapy with NEuroaid (ATHENE): A randomized double-blind delayed-start trial.
        J Am Med Dir Assoc. 2022; 23: 379-386
        • Torres-Castro S.
        • Rabaneda-Bueno R.
        • Lopez-Ortega M.
        • Gutierrez-Robledo
        • Guzman A.
        Multi-component staff training intervention to improve residential dementia care (PROCUIDA-Demencia): a mixed-methods two-arm cluster randomised controlled pilot and clinical outcomes study.
        J Am Med Dir Assoc. 2022; 23: 350-358
        • Konya I.
        • Iwata H.
        • Hayashi M.
        • et al.
        Effectiveness of weak wiping pressure during bed baths in hospitalized older adults: a single-blind randomized crossover trial.
        Geriatr Nurs. 2021; 42: 1379-1387
        • Kane R.L.
        • Huckfeldt P.
        • Tappen R.
        • et al.
        Effects of an intervention to reduce hospitalizations from nursing homes: a randomized implementation trial of the INTERACT program.
        JAMA Intern Med. 2017; 177: 1257-1264
        • Lathren C.
        • Sheffield-Abdullah K.
        • Sloane P.D.
        • et al.
        Certified nursing assistants' experiences with self-compassion training in the nursing home setting.
        Geriatr Nurs. 2021; 42: 1341-1348
        • Gaugler J.E.
        • Roth D.L.
        • Haley W.E.
        • Mittelman M.S.
        Can counseling and support reduce burden and depressive symptoms in caregivers of people with Alzheimer's disease during the transition to institutionalization? Results from the New York University caregiver intervention study.
        J Am Geriatr Soc. 2008; 56: 421-428
        • Huizing A.R.
        • Hamers J.P.
        • Gulpers M.J.
        • Berger M.P.
        A cluster-randomized trial of an educational intervention to reduce the use of physical restraints with psychogeriatric nursing home residents.
        J Am Geriatr Soc. 2009; 57: 1139-1148
        • Lee E.L.
        • Shin M.J.
        • Myoung K.K.
        • et al.
        The effect of IT convergence gamification training in community-dwelling older people: a multicenter, randomized controlled trial (RCT) study.
        J Am Med Dir Assoc. 2022; 23: 373-378
        • Rutten J.J.S.
        • van Buul L.W.
        • Smalbrugge M.
        • et al.
        An electronic health record integrated decision tool and supportive interventions to improve antibiotic prescribing for urinary tract infections in nursing homes: a cluster randomized controlled trial.
        J Am Med Dir Assoc. 2022; 23: 387-393
        • Boxer R.S.
        • Dolansky M.
        • Chaussee E.
        • et al.
        A randomized controlled trial of heart failure disease management versus usual care in skilled nursing facilities.
        J Am Med Dir Assoc. 2022; 23: 359-366
        • Weerahandi H.
        • Chaussee E.L.
        • Dodson J.A.
        • Dolansky M.
        • Boxer R.S.
        Disease management in skilled nursing facilities improves outcomes for patients with a primary diagnosis of heart failure.
        J Am Med Dir Assoc. 2022; 23: 367-372
        • Park J.
        • McCaffrey R.
        • Newman D.
        • Liehr P.
        • Ouslander J.G.
        A pilot randomized controlled trial of the effects of chair yoga on pain and physical function among community-dwelling older adults with lower extremity osteoarthritis.
        J Am Geriatr Soc. 2017; 65: 592-597
        • Gurwitz J.H.
        • Quinn C.C.
        • Abi-Elia I.H.
        • et al.
        Advancing clinical trials in nursing homes: a proposed roadmap to success.
        J Am Med Dir Assoc. 2022; 23: 345-349
        • Schwartz D.
        • Lellouch J.
        Explanatory and pragmatic attitudes in therapeutical trials.
        J Chronic Dis. 1967; 20: 637-648
        • Thorpe K.E.
        • Zwarenstein M.
        • Oxman A.D.
        • et al.
        A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers.
        J Clin Epidemiol. 2009; 62: 464-475
        • Ford I.
        • Norrie J.
        Pragmatic trials.
        N Engl J Med. 2016; 375: 454-463
        • US Department of Health and Human Services Office of Inspector General
        Adverse events in skilled nursing facilities: national incidence among Medicare beneficiaries.
        https://resourcesforrisk.com/docs/oei-06-11-00370.pdf
        Date: 2014
        Date accessed: December 26, 2021
        • Zimmerman S.
        • Love K.
        • Sloane P.D.
        • et al.
        Medication administration errors in assisted living: scope, characteristics, and the importance of staff training.
        J Am Geriatr Soc. 2011; 59: 1060-1068
        • Young H.M.
        • Gray S.L.
        • McCormick W.C.
        • et al.
        Types, prevalence, and potential clinical significance of medication administration errors in assisted living.
        J Am Geriatr Soc. 2008; 56: 1199-1205
        • Freedman V.A.
        • Spillman B.C.
        The residential continuum from home to nursing home: size, characteristics and unmet needs of older adults.
        J Gerontol B Psychol Sci Soc Sci. 2014; 69: S42-S50
        • Koch J.M.
        • Datta C.
        • Makhdoom S.
        • Grossberg G.T.
        Unmet visual needs of Alzheimer’s disease patients in long-term care facilities.
        J Am Med Dir Assoc. 2005; 6: 233-237
        • Cadieux M.A.
        • Garcia L.J.
        • Patrick J.
        Needs of people with dementia in long-term care: a systematic review.
        Am J Alzheimers Dis Other Demen. 2013; 28: 723-733
        • Shiells K.
        • Pivodic L.
        • Holmerová I.
        • Van den Block L.
        Self-reported needs and experiences of people with dementia living in nursing homes: a scoping review.
        Aging Ment Health. 2020; 24: 1553-1568
        • Zimmerman S.
        • Sloane P.D.
        • Ward K.
        • et al.
        Effectiveness of a mouth care program provided by nursing home staff vs standard care on reducing pneumonia incidence: a cluster randomized trial.
        JAMA Netw Open. 2020; 3: e204321
        • Zimmerman S.
        • Sloane P.D.
        Making pragmatic trials pragmatic in post-acute and long-term care settings.
        J Am Med Dir Assoc. 2019; 20: 107-109
        • Moyo P.
        • Loomer L.
        • Teno J.
        • et al.
        Effect of a video-assisted advance care planning intervention on end-of-life health care transitions among long-stay nursing home residents.
        J Am Med Dir Assoc. 2022; 23: 394-398
        • Sloane P.D.
        • Zimmerman S.
        • Ward K.
        • et al.
        A 2-year pragmatic trial of antibiotic stewardship in 27 community nursing homes.
        J Am Geriatr Soc. 2020; 68: 46-54
        • Resnick B.
        • Boltz M.
        • Galik E.
        • et al.
        Testing the implementation of function-focused care in assisted living settings.
        J Am Med Dir Assoc. 2021; 22: 1706-1713
        • Zimmerman S.
        • Wretman C.J.
        • Ward K.
        • et al.
        Fidelity and sustainability of Mouth Care Without a Battle and lessons for other innovations in care.
        Geriatr Nurs. 2020; 41: 878-884
        • Magid K.H.
        • Galenbeck E.
        • Levy C.
        How pragmatic are trials in nursing home settings?.
        J Am Med Dir Assoc. 2020; 21: 1821-1823
        • Resnick B.
        • Zimmerman S.
        • Gaugler J.
        • et al.
        Pragmatic trials in long-term care: research challenges and potential solutions in relation to key areas of care.
        J Am Med Dir Assoc. 2022; 23: 330-338
        • Levy C.
        • Zimmerman S.
        • Mor V.
        • et al.
        Pragmatic trials in long-term care: implementation and dissemination challenges and opportunities.
        J Am Med Dir Assoc. 2022; 23: 339-344
        • Zimmerman S.
        • Bowers B.J.
        • Cohen L.W.
        • et al.
        New evidence on the green house model of nursing home care: synthesis of findings and implications for policy, practice, and research.
        Health Serv Res. 2016; 51: 475-496
        • Centers for Medicare & Medicaid Services
        QAPI at a glance.
        • NIA IMPACT Collaboratory
        Transforming dementia care.
        https://impactcollaboratory.org/
        Date accessed: December 26, 2021
        • Jutkowitz E.
        • Brasure M.
        • Fuchs E.
        • et al.
        Care-delivery interventions to manage agitation and aggression in dementia nursing home and assisted living residents: a systematic review and meta-analysis.
        J Am Geriatr Soc. 2016; 64: 477-488
        • Zimmerman S.
        • Anderson W.L.
        • Brode S.
        • et al.
        Systematic review: effective characteristics of nursing homes and other residential long-term care settings for people with dementia.
        J Am Geriatr Soc. 2013; 61: 1399-1409
        • Scales K.
        • Zimmerman S.
        • Miller S.J.
        Evidence-based nonpharmacological practices to address behavioral and psychological symptoms of dementia.
        Gerontologist. 2018; 58: S88-S102
        • Mitchell S.L.
        • Volandes A.E.
        • Gutman R.
        • et al.
        Advance care planning video intervention among long-stay nursing home residents: a pragmatic cluster randomized clinical trial.
        JAMA Intern Med. 2020; 180: 1070-1078
        • Abraham J.
        • Kupfer R.
        • Behncke A.
        • et al.
        Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial.
        Int J Nurs Stud. 2019; 96: 27-34
        • Pype P.
        • Mertens F.
        • Helewaut F.
        • et al.
        Healthcare teams as complex adaptive systems: understanding team behaviour through team members’ perception of interpersonal interaction.
        BMC Health Serv Res. 2018; 18: 570
        • Anderson R.A.
        • Issel L.M.
        • McDaniel R.R.
        Nursing homes as complex adaptive systems: relationship between management practice and resident outcomes.
        Nurs Res. 2003; 52: 12-21
        • Zimmerman S.
        • Mitchell C.M.
        • Beeber A.
        • et al.
        Strategies to reduce potentially inappropriate antibiotic prescribing in assisted living and nursing homes. Agency for Healthcare Research and Quality.
        • Loudon K.
        • Treweek S.
        • Sullivan F.
        • et al.
        The PRECIS-2 tool: designing trials that are fit for purpose.
        BMJ. 2015; 350: h2147
        • Baier R.R.
        • Jutkowitz E.
        • Mitchell S.L.
        • McCreedy E.
        • Mor V.
        Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial.
        BMC Med Res Methodol. 2019; 19: 156
        • Viswanathan M.
        • Ammerman A.
        • Eng E.
        • et al.
        Community-based participatory research: assessing the evidence: summary. 2004 Aug. In: AHRQ Evidence Report Summaries. Agency for Healthcare Research and Quality (US); 1998-2005:99.
        • Van Malderen L.
        • De Vriendt P.
        • Mets T.
        • Verté D.
        • Gorus E.
        Experiences and effects of structurally involving residents in the nursing home by means of participatory action research: a mixed method study.
        J Am Med Dir Assoc. 2017; 18: 495-502
        • Love K.
        • Zimmerman S.
        • Cohen L.
        • the CEAL-UNC Collaborative
        A manual for community-based participatory research: using research to improve practice and inform policy in assisted living.
        2009 (CES4 Health.info)
      1. NIH Exempt Human Subjects Research.
        • Weir C.R.
        • Staggers N.
        • Gibson B.
        • et al.
        A qualitative evaluation of the crucial attributes of contextual information necessary in EHR design to support patient-centered medical home care.
        BMC Med Inform Decis Mak. 2015; 15: 30
        • McKnights Long-Term Care News
        Data-driven partnerships.
        https://www.mcknights.com/news/data-driven-partnerships/
        Date: July 2, 2012
        Date accessed: December 26, 2021
        • McKnights Long-Term Care News
        Holleran research firm adds business analytics, community metrics.
        • Oxman A.D.
        • Thomson M.A.
        • Davis D.A.
        • et al.
        No magic bullets: a systematic review of 102 trials of interventions to improve professional practice.
        CMAJ. 1995; 153: 1423-1431
      2. Why is Social Media Important to Researchers?.
        • Carpenter D.
        • Nieva V.
        • Albaghal T.
        • Sorra J.
        Development of a planning tool to guide research.
        (In: Henriksen K, Battles JB, Marks ES, et al, eds. Advances in Patient Safety: From Research to Implementation, vol 4: Programs, Tools, and Products)
        • Alzheimer’s Association
        2021 Alzheimer’s disease facts and figures.
      3. 2021 Alzheimer’s disease facts and figures. Special report: race, ethnicity and Alzheimer’s in America. HealthinAging.org.
        • Colón-Emeric C.
        • Toles M.
        • Cary Jr., M.P.
        • et al.
        Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers.
        Implement Sci. 2016; 11: 94