Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop

Baier, Rosa R.; Mitchell, Susan L.; Jutkowitz, Eric; Mor, Vincent

doi:10.1016/j.jamda.2018.02.011

Cited by 21 publications

(32 citation statements)

References 10 publications

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“…The workshop and its results, including infrastructure recommendations, are detailed elsewhere [6, 7]. Three of the authors served as chairs (RB, SM, and VM) and two presented and attended (EJ and EM).…”

Section: Methodsmentioning

confidence: 99%

“…After the workshop, we summarized participants’ recommended criteria for determining the characteristics of interventions ready for PCTs [6, 7], and used recommended criteria to define domains to assess interventions for PCT readiness. Inspired by the PRECIS framework, we developed initial guidelines for assessing each domain and a graphical summary to plot domain assessments.…”

Section: Methodsmentioning

confidence: 99%

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Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

Baier

Jutkowitz

Mitchell

et al. 2019

BMC Med Res Methodol

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Background Pragmatic randomized, controlled trials (PCTs) test the effectiveness of interventions implemented in routine clinical practice. Because PCT findings are generalizable, this approach is gaining momentum among interventionists and funding agencies seeking to accelerate the testing and adoption of evidence-based strategies to improve care and outcomes. Particular attention is being paid to non-pharmacological interventions, which are often complex and may be difficult to uniformly implement across multiple sites. While many such non-pharmacological interventions have proven efficacious in small trials, most have not been widely adopted. PCTs could accelerate effectiveness testing and adoption, yet there are no established criteria to identify interventions ready for testing in a PCT. Methods We convened 30 interventionists and healthcare leaders to identify criteria to assess the readiness of non-pharmacological interventions for PCTs. Based on this discussion, we created a model with multiple domains, qualitative scoring guidelines for each domain, and a graphical summary of readiness assessments. All workshop participants had an opportunity to review and comment on the resulting model; three piloted it with their own interventions. Several other experts also provided input. Results The Readiness Assessment for Pragmatic Trials (RAPT) model enables interventionists to assess an intervention’s readiness for PCTs. RAPT includes nine domains: implementation protocol, evidence, risk, feasibility, measurement, cost, acceptability, alignment, and impact. Domains reflect a range of considerations regarding the feasibility of successfully employing PCT methods and the prospect of an intervention’s widespread adoption, if proven effective. Individuals evaluating an intervention are asked to qualitatively assess each domain from low to high readiness. In this report, we provide assessment guidelines and examples of scored interventions. Conclusions RAPT is the first model to help interventionists and funders assess the extent to which interventions are ready for PCTs. Scoring efficacious interventions using RAPT can inform research team discussions regarding whether or not to advance an intervention to effectiveness testing using a PCT and how do design that PCTs.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

Baier

Jutkowitz

Mitchell

et al. 2019

BMC Med Res Methodol

Self Cite

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“…Alternative study designs such as realist evaluation, which seeks to understand complexity and service delivery context, may be more appropriate (86). Pragmatic trials also offer a robust method for testing interventions in real-world contexts and work is progressing to create a framework for supporting pragmatic trials of psychosocial interventions (87).…”

Section: Table 4 About Here: Table 4: Possible Dimensions For a Classmentioning

confidence: 99%

Psychosocial Interventions for Community-Dwelling People Following Diagnosis of Mild to Moderate Dementia: Findings of a Systematic Scoping Review

Keogh

Mountain

Joddrell

et al. 2019

The American Journal of Geriatric Psychiatry

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National policies and evidence reviews recommend psychosocial interventions (PIs) as an essential support, particularly in the period following dementia diagnosis. However, the availability and uptake of these interventions is comparatively low. One of the reasons for this is that clinicians lack information about what might be provided and the potential benefits of different interventions. This paper identifies and describes psychosocial interventions for community dwelling people following diagnosis of mild to moderate dementia and presents the available evidence to inform practice decisions. A systematic scoping review was employed to map the evidence relating to PIs for this group. This identified 63 relevant studies, testing 69 interventions, which could be grouped into six categories; 20 cognition-oriented interventions; 11 behaviour-oriented; 11 stimulation-oriented; 13 emotion-oriented, 5 social-oriented and 9 multi-modal. There were three targets for outcome measurement of these PIs; the person with dementia, the family carer and the person-carer dyad. Over 154 outcome measures were identified in the studies with outcomes measured across 11 main domains. The lack of a classification framework for PIs means it is difficult to create a meaningful synthesis of the breadth of relevant evidence to guide clinical practice. Possible dimensions of a classification framework are proposed to begin to address this gap.

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“…8 Prior research has elucidated opportunities to improve the care of PLWD and their CGs, and some small-scale traditional clinical trials of nonpharmacologic interventions targeting these opportunities have demonstrated efficacy in improving outcomes. 9 However, the adoption of promising interventions into practice has been stymied by the lack of research evaluating their effectiveness when implemented under real-world conditions. Embedded pragmatic clinical trials (ePCTs) in healthcare systems (HCS) that serve PLWD have the potential to accelerate the translation of evidencebased interventions into clinical practice.…”

Section: Introductionmentioning

confidence: 99%

“…Embedded pragmatic clinical trials (ePCTs) in healthcare systems (HCS) that serve PLWD have the potential to accelerate the translation of evidencebased interventions into clinical practice. [9][10][11][12][13][14] In 2012, the National Institutes of Health (NIH) invested in infrastructure via the NIH HCS Research Collaboratory to strengthen the national capacity to conduct ePCTs in partnership with HCS. 13,15 The NIH HCS Collaboratory has made pivotal contributions toward advancing the conduct of all aspects of ePCTs through its knowledge, development, and dissemination, establishment of the Distributed Research Network, 16 and real-time support of an array of full-scale ePCTs in a variety of settings and medical disciplines.…”

Section: Introductionmentioning

confidence: 99%

Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory

Mitchell

Mor

Harrison

et al. 2020

J American Geriatrics Society

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Close to 6 million Americans have Alzheimer's disease (AD) or Alzheimer's disease and related dementia (AD/ADRD). These high-need, high-cost patients are vulnerable to receiving poor quality uncoordinated care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. Improving the care of persons living with dementia (PLWD) and their caregivers is an urgent public health challenge that must be informed by high-quality evidence. Although prior research has elucidated opportunities to improve AD/ADRD care, the adoption of promising interventions has been stymied by the lack of research evaluating their effectiveness when implemented under real-world conditions. Embedded pragmatic clinical trials (ePCTs) in healthcare systems have the potential to accelerate the translation of evidence-based interventions into clinical practice. Building from the foundation of the National Institutes of Healthcare Systems Collaboratory, in September 2019 the National Institute on Aging Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory was launched. Its mission is to build the nation's capacity to conduct ePCTs within healthcare systems for PLWD and their caregivers by (1) developing and disseminating best practice research methods, (2) supporting the design and conduct of ePCTs including pilot studies, (3) building investigator capacity through training and knowledge generation, (4) catalyzing collaboration among stakeholders, and (5) ensuring the research includes culturally tailored interventions for people from diverse backgrounds. This report presents the rationale, structure, key activities, and markers of success for the overall NIA IMPACT Collaboratory. The articles that follow in this special Issue describe the specific work of its 10 core working groups and teams.

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Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop

Cited by 21 publications

References 10 publications

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

Psychosocial Interventions for Community-Dwelling People Following Diagnosis of Mild to Moderate Dementia: Findings of a Systematic Scoping Review

Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory

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