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 — BEHAVIORALBrief 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 CareUsual 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- HFDuring 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
- Mark Neuman, MD215-746-7468
- Karah Whatley
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida Gainesville | Gainesville | Florida | 32608 | Joshua Sappenfield Joshua Sapenfield, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Carlos Guerra Londono Carlos Guerra Londono, MD (PRINCIPAL_INVESTIGATOR) |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | Stacie G Deiner |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Lynette Harris, BSN Christopher Edwards, MD (SUB_INVESTIGATOR) |
| Cleveland Clinic-Fairview | Cleveland | Ohio | 44195 | Sabry Ayad Sabry Ayad, MD (PRINCIPAL_INVESTIGATOR) |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | James Baraldi, PhD Mark Neuman, MD (PRINCIPAL_INVESTIGATOR) Veena Graff, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Gainesville, FL
Related Studies
- Conjoint Analysis of Patient Preferences in Joint InterventionsEnrolling By Invitation · Duke University · Durham, North Carolina
- Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood TransfusionPHASE4 · Recruiting · Gregory M Georgiadis MD · Toledo, Ohio
- HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 TrialRecruiting · Population Health Research Institute · Chandler, Arizona
- G7 Dual Mobility With Vivacit-E or Longevity PMCFEnrolling By Invitation · Zimmer Biomet · Little Rock, Arkansas