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

Purpose

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

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Stepped Wedge Cluster Randomized Trial
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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)

Recruiting Locations

University of Florida Gainesville
Gainesville, Florida 32608
Contact:
Joshua Sappenfield

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Carlos Guerra Londono

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
Contact:
Stacie G Deiner

Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
Contact:
Lynette Harris, BSN

Cleveland Clinic-Fairview
Cleveland, Ohio 44195
Contact:
Sabry Ayad

Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
Contact:
James Baraldi, PhD

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Mark Neuman, MD
215-746-7468
neumanm@pennmedicine.upenn.edu

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.