Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Pennsylvania
Study ID
NCT06438640
Status
Recruiting

Conditions

  • Femoral Neck Fractures
  • Hip Fractures
  • Intertrochanteric Fractures
  • Subtrochanteric Fractures

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • My Anesthesia Choice-HF Model — BEHAVIORAL
    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)

Study Details

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.

Key Dates

Start date
Aug 15, 2024
Status verified
Mar 2026
Primary completion
Jun 15, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
1,881 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Intervention reach (primary implementation outcome) [ Time Frame: Day of surgery ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Florida GainesvilleGainesvilleFlorida32608
Joshua Sappenfield
Joshua Sapenfield, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Carlos Guerra Londono
Carlos Guerra Londono, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766
Stacie G Deiner
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157
Lynette Harris, BSN
Christopher Edwards, MD (SUB_INVESTIGATOR)
Cleveland Clinic-FairviewClevelandOhio44195
Sabry Ayad
Sabry Ayad, MD (PRINCIPAL_INVESTIGATOR)
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
James Baraldi, PhD
Mark Neuman, MD (PRINCIPAL_INVESTIGATOR)
Veena Graff, MD (PRINCIPAL_INVESTIGATOR)

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