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PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.
Clin Trials. 2017 Apr; 14(2):140-151.CT

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+Show Affiliations

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.3 Section of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA. 4 Harvard Medical School, Boston, MA, USA.5 Department of Biostatistics, School of Public Health, Brown University, Providence, RI, USA.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.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.

Pub Type(s)

Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial

Language

eng

PubMed ID

28068789

Citation

Mor, Vincent, et al. "PRagmatic Trial of Video Education in Nursing Homes: the Design and Rationale for a Pragmatic Cluster Randomized Trial in the Nursing Home Setting." Clinical Trials (London, England), vol. 14, no. 2, 2017, pp. 140-151.
Mor V, Volandes AE, Gutman R, et al. PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting. Clin Trials. 2017;14(2):140-151.
Mor, V., Volandes, A. E., Gutman, R., Gatsonis, C., & Mitchell, S. L. (2017). PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting. Clinical Trials (London, England), 14(2), 140-151. https://doi.org/10.1177/1740774516685298
Mor V, et al. PRagmatic Trial of Video Education in Nursing Homes: the Design and Rationale for a Pragmatic Cluster Randomized Trial in the Nursing Home Setting. Clin Trials. 2017;14(2):140-151. PubMed PMID: 28068789.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting. AU - Mor,Vincent, AU - Volandes,Angelo E, AU - Gutman,Roee, AU - Gatsonis,Constantine, AU - Mitchell,Susan L, Y1 - 2017/01/09/ PY - 2017/1/11/pubmed PY - 2017/12/1/medline PY - 2017/1/11/entrez KW - Cluster randomized clinical trial KW - advance care planning KW - decision aids KW - end of life KW - nursing home KW - pragmatic trial SP - 140 EP - 151 JF - Clinical trials (London, England) JO - Clin Trials VL - 14 IS - 2 N2 - 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. SN - 1740-7753 UR - https://www.unboundmedicine.com/medline/citation/28068789/PRagmatic_trial_Of_Video_Education_in_Nursing_homes:_The_design_and_rationale_for_a_pragmatic_cluster_randomized_trial_in_the_nursing_home_setting_ L2 - http://journals.sagepub.com/doi/full/10.1177/1740774516685298?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -