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Table 2 Assessment of the TRAIN-AD design features along the explanatory–pragmatic continuum in the nine domains of the PRECIS-2 framework

From: The trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias: study protocol for a cluster randomized controlled trial

Domains (score)a Rationales
Eligibility (4) Explanatory: The trial is limited to residents in facilities in the Boston area
Pragmatic: All eligible residents are enrolled and are typical of nursing home (NH) residents with advanced dementia
Recruitment (3) Explanatory: Considerable effort is required by the research team to recruit NHs and identify eligible residents
Pragmatic: Once identified, all eligible residents are enrolled
Setting (3) Explanatory: Participant NHs are limited to those that agreed to participate and the Boston area. NHs that refuse to participate and those in other regions may differ from participating facilities (demographics, culture, approach to care)
Pragmatic: Participant NHs are typical of those caring for advanced dementia residents
Organization (3) Explanatory: The research team designed the intervention structure, provides resources, delivers the main training seminar, and offers incentives to complete the online course
Pragmatic: The intervention implementation is done in partnership with the site champion. The intervention is not resource-intensive and has high potential for implementation outside of a research trial, as it aligns closely with federal mandates for antimicrobial stewardship programs [47]. Moreover, the online course is publicly available and thus not limited to TRAIN-AD providers
Flexibility–delivery
(3)
Explanatory: The intervention delivery is largely dictated by the research protocol, such as the timing of training seminars, time frame to complete online course, mailing of booklets to families, and provision of feedback reports
Pragmatic: Aspects of the implementation delivery are adaptable; e.g., providers can do the training seminar in an abbreviated one-on-one orientation rather than attend the group session, and other antimicrobial stewardship and/or advance care planning programs outside of the TRAIN-AD protocol are permitted to continue
Flexibility–adherence (3) Explanatory: Provider participation is voluntary but closely monitored and reinforced as part of the research protocol using compensations and provider feedback reports
Pragmatic: Treatment decisions are left to the discretion of clinical providers and not mandated by the research protocol
Follow-up (3) Explanatory: All participant follow-ups are rigorously conducted by two research assistants
Pragmatic: Follow-ups only involve abstraction of information from the residents’ charts collected as part of clinical care
Primary outcome
(4)
Pragmatic: The primary outcome closely aligns with key measures of federal mandated antimicrobial stewardship programs [47], and is thus highly relevant to key stakeholders and can be ascertained using electronic medical charts
Primary analysis
(5)
Pragmatic: it will follow the intention-to-treat principle using all available data. Poorly adherent facilities will not be excluded from the analysis
  1. aEach domain is scored as follows: very explanatory (1), rather explanatory (2), equally explanatory and pragmatic (3), rather pragmatic (4), and very pragmatic (5)
  2. PRECIS-2 Pragmatic–Explanatory Continuum Indicator Summary 2 [29], TRAIN-AD Trial to Reduce Antimicrobial use In Nursing home residents with Alzheimer’s disease and other Dementias