Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
NCT ID: NCT06438640
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3548 participants
INTERVENTIONAL
2024-08-15
2028-05-15
Brief Summary
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Detailed Description
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Activities at each site will be divided into three phases: Pre-Implementation; Active Implementation; and Sustainment. Data collection will occur across all study phases at each site, although specific data elements collected will vary across phases. To facilitate evaluation, sites will be randomly assigned to one of three possible timing sequences (A, B, C) for project implementation (2 sites/sequence). The duration of the active implementation phase will be the same for each sequence (12 months); however, the duration of pre-implementation and sustainment phases will vary across sequences.
During the pre-implementation phase, data collection on selected outcome variables will occur but no interventions will be delivered. During the implementation phase, site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients. Data collection on key outcomes will continue over this period, and clinicians will receive reminders to encourage tool use. During Sustainment, the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual Care
Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site.
No interventions assigned to this group
My Anesthesia Choice- HF
During the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness.
My Anesthesia Choice-HF Model
Brief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia)
Interventions
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My Anesthesia Choice-HF Model
Brief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia)
Eligibility Criteria
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Inclusion Criteria
Exclusion:
Contraindication to spinal anesthesia: current anticoagulant therapy or coagulopathy Contraindication to spinal anesthesia: critical aortic stenosis Contraindication to spinal anesthesia: skin infection over the lumbar spine
50 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
University of Florida
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Henry Ford Health System
OTHER
The Cleveland Clinic
OTHER
Dartmouth College
OTHER
Washington University School of Medicine
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Mark Neuman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Florida Gainesville
Gainesville, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic-Fairview
Cleveland, Ohio, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Joshua Sappenfield
Role: primary
Carlos Guerra Londono
Role: primary
Stacie G Deiner
Role: primary
Lynette Harris, BSN
Role: primary
Sabry Ayad
Role: primary
James Baraldi, PhD
Role: primary
References
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Goldstein EC, Politi MC, Baraldi JH, Elwyn G, Campos H, Feng R, Mehta S, Whatley K, Schmitz V, Neuman MD. Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3.
Other Identifiers
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855203
Identifier Type: -
Identifier Source: org_study_id
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