About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Sequential
Treatments tested in this trial
My Anesthesia Choice-HF Model
BehavioralBrief 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)
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Secondary outcomes
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
Other outcomes
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.
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
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.
Anesthesia type received
The fraction of patients receiving general versus spinal anesthesia will be compared during the pre-implementation versus active implementation periods.
Sponsors and contacts
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University of Pennsylvania
Lead sponsor
Wake Forest University Health Sciences
Collaborator
University of Florida
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
Henry Ford Health System
Collaborator
The Cleveland Clinic
Collaborator
Dartmouth College
Collaborator
Washington University School of Medicine
Collaborator