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

NCT06438640 | Recruiting

• 1 other identifier: 855203
• Study Type: interventional
• Target: 1,881
• Locations: 1 country
• Sites: 6

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; Subtrochanteric Fractures; Femoral Neck Fractures; Intertrochanteric Fractures

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• CollaboRATE shared decision making scale score (secondary effectiveness outcome).

  Postoperative day 0-3

Other Outcomes (8)

• Decisional conflict

  Postoperative day 0-3

• Knowledge regarding anesthesia options

  Postoperative day 0-3

• Willingness to recommend anesthesia type

  Postoperative day 0-3

Study Arms (2)

Usual Care

NO INTERVENTION

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.

My Anesthesia Choice- HF

ACTIVE COMPARATOR

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

Interventions

My Anesthesia Choice-HF Model BEHAVIORAL

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)

My Anesthesia Choice- HF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 and older Planned surgery to treat a hip fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Henry Ford Health System: collaborator
• The Cleveland Clinic: collaborator
• Dartmouth College: collaborator
• University of Pennsylvania: lead
• Wake Forest University Health Sciences: collaborator
• Washington University School of Medicine: collaborator

Study Sites (6)

University of Florida Gainesville

Gainesville, Florida, 32608, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic-Fairview

Cleveland, Ohio, 44195, United States

RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39267183 DERIVED

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Mark Neuman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Neuman, MD

CONTACT

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

Karah Whatley

CONTACT

karah.whatley@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped Wedge Cluster Randomized Trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (6)