title: PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.
abstract: 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.
authors.affiliation: 1 Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, RI, USA.|2 Providence Veterans Administration Medical Center, Center of Innovation in Health Services Research and Development Service, Providence, RI, USA.
authors.forename: Vincent
authors.initials: V
authors.lastname: Mor
authors.affiliation: 3 Section of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.|4 Harvard Medical School, Boston, MA, USA.
authors.forename: Angelo E
authors.initials: AE
authors.lastname: Volandes
authors.affiliation: 5 Department of Biostatistics, School of Public Health, Brown University, Providence, RI, USA.
authors.forename: Roee
authors.initials: R
authors.lastname: Gutman
authors.affiliation: 5 Department of Biostatistics, School of Public Health, Brown University, Providence, RI, USA.|6 Center for Statistical Sciences, School of Public Health, Brown University, Providence, RI, USA.
authors.forename: Constantine
authors.initials: C
authors.lastname: Gatsonis
authors.affiliation: 4 Harvard Medical School, Boston, MA, USA.|7 Hebrew SeniorLife, Institute for Aging Research, Boston, MA, USA.|8 Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Mitchell
mesh_terms: D032722:Advance Care Planning; D001296:Audiovisual Aids; D003661:Decision Support Techniques; D003704:Dementia / Q000628:therapy; D006331:Heart Diseases / Q000628:therapy; D006760:Hospitalization; D006801:Humans; D008171:Lung Diseases / Q000628:therapy; D009735:Nursing Homes; D010353:Patient Education as Topic; D012720:Severity of Illness Index; D014741:Video Recording
keywords: Cluster randomized clinical trial; advance care planning; decision aids; end of life; nursing home; pragmatic trial