Recruiting

Anesthesia Choice

Sponsor:

University of Pennsylvania

Code:

NCT06438640

Conditions

Hip Fractures

Femoral Neck Fractures

Intertrochanteric Fractures

Subtrochanteric Fractures

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

My Anesthesia Choice-HF Model

Study Details

Brief summary:

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.

Conditions

Hip Fractures

Femoral Neck Fractures

Intertrochanteric Fractures

Subtrochanteric Fractures

Study ID

NCT06438640

Start date

Aug 15, 2024

Status verified date

Mar, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion:

Age 50 and older Planned surgery to treat a hip fracture

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

Study Design

Enrollment

1881 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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)

Primary outcome measure

  • Intervention reach (primary implementation outcome) [ Time Frame: Day of surgery ]
  • Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome) [ Time Frame: Postoperative day 0-3 ]

Central Contacts and Locations

Central contacts

Mark Neuman, MD

215-746-7468neumanm@pennmedicine.upenn.edu

Karah Whatley

karah.whatley@pennmedicine.upenn.edu

Locations

University of Florida Gainesville

Recruiting

Gainesville, Florida, United States, 32608

Principal Investigator:

Joshua Sapenfield, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Carlos Guerra Londono, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Cleveland Clinic-Fairview

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Sabry Ayad, MD

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Mark Neuman, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • hip fracture
  • femoral neck
  • intertrochanteric
  • subtrochanteric
  • fracture
  • anesthesia
  • observational study
  • survey
  • shared decision making
  • My Anesthesia Choice
  • MAC-HF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-12.