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

Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Femoral Neck Fractures; Intertrochanteric Fractures; Subtrochanteric Fractures
• Intervention / Treatment: Behavioral: My Anesthesia Choice-HF Model

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.

• Study Type: Interventional
• Enrollment (Estimated): 1881
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Neuman, MD; Phone Number: 215-746-7468; Email: neumanm@pennmedicine.upenn.edu
• Study Contact Backup: Name: Karah Whatley; Email: karah.whatley@pennmedicine.upenn.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida Gainesville
      • Contact: Joshua Sappenfield
      • Principal Investigator: Joshua Sapenfield, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Carlos Guerra Londono
      • Principal Investigator: Carlos Guerra Londono, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth Hitchcock Medical Center
      • Contact: Stacie G Deiner
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Baptist Medical Center
      • Contact: Lynette Harris, BSN
      • Sub-Investigator: Christopher Edwards, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic-Fairview
      • Principal Investigator: Sabry Ayad, MD
      • Contact: Sabry Ayad
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center
      • Contact: James Baraldi, PhD
      • Principal Investigator: Mark Neuman, MD
      • Principal Investigator: Veena Graff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention reach (primary implementation outcome)	Reach of the intervention will be assessed as the rate of use of the conversation aid during the active implementation phase at each site among eligible patients during the pre-anesthesia evaluation. Data will be collected during the implementation phase at each site.	Day of surgery
Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)	SDMP is a 4-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods	Postoperative day 0-3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CollaboRATE shared decision making scale score (secondary effectiveness outcome).	A 3-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods	Postoperative day 0-3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	The fraction of patients reporting decisional conflict about anesthesia pre-implementation versus active implementation periods will be assessed via the 4-item SURE measure.	Postoperative day 0-3
Knowledge regarding anesthesia options	Patient-reported knowledge about anesthesia options during the pre-implementation versus active implementation periods will be assessed by a 6-item brief knowledge evaluation	Postoperative day 0-3
Willingness to recommend anesthesia type	Patient satisfaction with anesthesia care during the pre-implementation versus active implementation periods will be assessed by a single-item "willingness to recommend to friends and family" satisfaction measure.	Postoperative day 0-3
Anesthesia type received	The fraction of patients receiving general versus spinal anesthesia will be compared during the pre-implementation versus active implementation periods.	Day of surgery
Recovery of ambulation	The fraction of patients who are able to ambulate independently (i.e. without human assistance) at first clinic follow up between 30 and 90 days after surgery will be compared during the pre-implementation versus implementation periods.	Postoperative day 30 to 90
Fidelity of intervention delivery	Fidelity of implementation to recommended best practices during active implementation and sustainment phases, assessed via the 9-item UPFRONT Fidelity Assessment. This item will be assessed on approximately 10% of patients treated in each phase	Day of surgery
Sustainment of intervention	The percentage of eligible patients receiving the strategy during the sustainment phase	Day of surgery
Perceived sustainability of the intervention	Study clinicians' perceptions regarding sustainability of the intervention will be assessed during the implementation and sustainment phases via the 23-item NoMAD sustainability assessment.	Study months 12-27

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Washington University School of Medicine; The Cleveland Clinic; University of Florida; Wake Forest University Health Sciences; Dartmouth-Hitchcock Medical Center; Henry Ford Health System; Dartmouth College
• Investigators: Principal Investigator: Mark Neuman, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Goldstein EC, Politi MC, Baraldi JH, Elwyn G, Campos H, Feng R, Mehta S, Whatley K, Schmitz V, Neuman MD. Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; shared decision making; fracture; observational study; survey; hip fracture; intertrochanteric; femoral neck; subtrochanteric; My Anesthesia Choice; MAC-HF
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 855203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No