{ "abstract": "Introduction The objective of this trial is to test whether a family-augmented version of the Hospital Elder Life Program (FAM-HELP) is superior to conventional HELP for prevention of delirium in older patients during hospital admission.Methods and analysis This is a multicentre, stepped-wedge, cluster randomised clinical trial comparing HELP to FAM-HELP. The trial will employ an effectiveness-implementation design (hybrid type I), simultaneously evaluating FAM-HELP effectiveness compared with conventional HELP, while also measuring implementation barriers and facilitators. The primary outcomes are delirium incidence (via long-form Confusion Assessment Method, CAM) and delirium severity (CAM-S Severity Score). Secondary outcomes related to delirium will also be collected, including patient-reported and caregiver-reported delirium burden, delirium duration, length of hospital stay and discharge disposition. Outcome assessors are masked to intervention arm, and intervention teams are masked to delirium status and other study outcomes. The primary statistical analysis will be based on generalised estimating equations with an intention-to-treatment principle and secondary analyses will include strategies for incorporating protocol fidelity and adherence into models. The planned sample size is 1900 patients, which will provide ≥80% power based on estimated parameters. Prespecified subgroup analyses are also planned for exploring heterogeneity of treatment effects.Ethics and dissemination The trial was approved by the University of Michigan Institutional Review Board (IRBMED, HUM00227397), which serves as the single IRB with ceded review from all performance sites. Recruitment began in December 2023 and is expected to continue until summer 2027. Comprehensive verbal informed consent is obtained from all patient and family care partner participants. An independent safety officer has been commissioned to oversee trial operations and provide guidance to the Patient-Centered Outcomes Research Institute. Results will be disseminated via medical journals, academic conferences, dissemination stakeholder partner organisations and news media.Trial registration number NCT05929703.", "abstract_shown": true, "affiliations": [ "Department of Anesthesiology, Michigan Medicine, Ann Arbor, Michigan, USA", "Center for Consciousness Science, University of Michigan, Ann Arbor, Michigan, USA", "Department of Biostatistics, Yale School of Public Helath, New Haven, Connecticut, USA", "Aging Brain Center, Hinda and Arthur Marcus Institute for Aging Research, Boston, Massachusetts, USA", "Schneider Institutes for Health Policy and Research, Brandeis University, Waltham, Massachusetts, USA", "Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA", "Indiana University Center for Aging Research, Indianapolis, Indiana, USA", "Regenstrief Institute Inc, Indianapolis, Indiana, USA", "Center for Health Innovation and Implementation Science, Indiana Clinical and Translational Sciences Institute, Indianapolis, Indiana, USA", "UnityPoint Health - Meriter, Madison, Wisconsin, USA", "MaineHealth Senior Care, Portland, Maine, USA", "Department of Family Medicine, Tufts University School of Medicine, Boston, Massachusetts, USA", "MemioralCare Saddleback Medical Center, Laguna Hills, California, USA", "Division of Geriatric and Palliative Medicine, Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan, USA", "Geriatric Research Education and Clinical Center, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, USA", "Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA", "Division of Geriatrics, Allegheny Health Network, Pittsburgh, Pennsylvania, USA", "Department of Internal Medicine, The University of Utah School of Medicine, Salt Lake City, Utah, USA", "Duke University School of Medicine, Durham, North Carolina, USA", "Family Stakeholder Core, ENHANCE Trial, New York, New York, USA", "The Mongan Institute, Massachusetts General Hospital, Boston, Massachusetts, USA" ], "article_type": null, "arxiv": null, "author_total": 20, "authors": [ { "affs": [ 0, 1 ], "name": "Phillip E Vlisides", "orcid": "0000-0003-3899-5536" }, { "affs": [ 0 ], "name": "Graciela Mentz" }, { "affs": [ 2 ], "name": "Fan Li", "orcid": "0000-0001-6183-1893" }, { "affs": [ 3 ], "name": "Tamara G Fong" }, { "affs": [ 3 ], "name": "Eva M Schmitt" }, { "affs": [ 0 ], "name": "Amy M McKinney" }, { "affs": [ 4 ], "name": "Karen Donelan" }, { "affs": [ 5, 6, 7, 8 ], "name": "Malaz Boustani" }, { "affs": [ 9 ], "name": "Carrie Bennett" }, { "affs": [ 10, 11 ], "name": "Emily L C Stuckey", "orcid": "0009-0002-6061-9019" }, { "affs": [ 12 ], "name": "Elizabeth Chassagne" }, { "affs": [ 13, 14 ], "name": "Shenbagam Dewar" }, { "affs": [ 15 ], "name": "Rebecca Trotta" }, { "affs": [ 16 ], "name": "Lyn Weinberg" }, { "affs": [ 17 ], "name": "Roxanne Weiss" }, { "affs": [ 13 ], "name": "Jocelyn Wiggins" }, { "affs": [ 18 ], "name": "Dan Blazer" }, { "affs": [ 19 ], "name": "Mary Cramer" }, { "affs": [ 20 ], "name": "Stephen J Bartels" }, { "affs": [ 3 ], "name": "Sharon K Inouye" } ], "bibtex": "https://research.draconitic.com/paper/e8gp2azj7x6w0.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-123408", "fulltext_url": "https://bmjopen.bmj.com/content/16/11/e123408.full", "id": "e8gp2azj7x6w0", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123408", "language": "en", "licence": "CC-BY", "licence_label": "CC BY", "licence_source": "journal", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "lcc", "R" ] ], "openalex": null, "pdf_url": null, "pmcid": null, "pmid": null, "published": "2026-11-05", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/e8gp2azj7x6w0.ris", "sources": [ { "first_seen": "2026-11-06T00:21:22Z", "native_id": "10.1136/bmjopen-2026-123408", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123408" }, { "first_seen": "2026-11-09T14:21:24Z", "native_id": "e011e9542d224bf4895d7b3fe15f7cdb", "source": "doaj", "url": "https://doi.org/10.1136/bmjopen-2026-123408" } ], "subjects": [ { "field": "medicine", "origin": "lcc:R", "subfield": "general" } ], "title": "Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalised Elders (ENHANCE): protocol for a stepped wedge, cluster randomised clinical trial for delirium prevention in older adults", "title_text": "Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalised Elders (ENHANCE): protocol for a stepped wedge, cluster randomised clinical trial for delirium prevention in older adults", "type": "peer-reviewed", "updated_at": "2026-11-09T14:21:24Z", "url": "https://research.draconitic.com/paper/e8gp2azj7x6w0", "venue": "BMJ Open", "versions": [] }