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NCT06438640NARecruiting

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

University of Pennsylvania

Start Date

8/15/2024

Completion Date

6/15/2028

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.

Detailed Description

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. 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 (16 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.

Eligibility Criteria

Age Range: 50 years to No maximum

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

Interventions

BEHAVIORAL

My Anesthesia Choice-HF Model

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Conditions

Hip FracturesFemoral Neck FracturesIntertrochanteric FracturesSubtrochanteric Fractures

Locations

University of Florida Gainesville

Gainesville, Florida 32608

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03766

United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic-Fairview

Cleveland, Ohio 44195

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104

United States