Clinical trial NCT06438640: Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
Official title: Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Femoral Neck Fractures
Intertrochanteric Fractures
Subtrochanteric Fractures
Keywords: hip fracture
femoral neck
intertrochanteric
subtrochanteric
fracture
anesthesia
observational study
survey
shared decision making
My Anesthesia Choice
MAC-HF
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: University of Florida
name: Dartmouth-Hitchcock Medical Center
name: Henry Ford Health System
name: The Cleveland Clinic
name: Dartmouth College
name: Washington University School of Medicine
First posted: 2024-06-03
Enrollment: 3548
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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 27 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 27 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 (12 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: 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

Primary outcomes:
measure: Intervention reach (primary implementation outcome)
timeFrame: Day of surgery
measure: Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)
timeFrame: Postoperative day 0-3
Secondary outcomes:
measure: CollaboRATE shared decision making scale score (secondary effectiveness outcome).
timeFrame: Postoperative day 0-3
Other outcomes:
measure: Decisional conflict
timeFrame: Postoperative day 0-3
measure: Knowledge regarding anesthesia options
timeFrame: Postoperative day 0-3
measure: Willingness to recommend anesthesia type
timeFrame: Postoperative day 0-3
measure: Anesthesia type received
timeFrame: Day of surgery
measure: Recovery of ambulation
timeFrame: Postoperative day 30 to 90
measure: Fidelity of intervention delivery
timeFrame: Day of surgery
measure: Sustainment of intervention
timeFrame: Day of surgery
measure: Perceived sustainability of the intervention
timeFrame: Study months 12-27
Locations:
city: Gainesville
country: United States
facility: University of Florida Gainesville
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic-Fairview
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mark Neuman, MD
role: PRINCIPAL_INVESTIGATOR
References: