NCT Number: NCT06438640
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
University of Florida Gainesville, Gainesville, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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)
Time frame: Day of surgery
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.
Time frame: Postoperative day 0-3
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
Time frame: Postoperative day 0-3
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
Time frame: Postoperative day 0-3
The fraction of patients reporting decisional conflict about anesthesia pre-implementation versus active implementation periods will be assessed via the 4-item SURE measure.
Time frame: Postoperative day 0-3
Patient-reported knowledge about anesthesia options during the pre-implementation versus active implementation periods will be assessed by a 6-item brief knowledge evaluation
Time frame: Postoperative day 0-3
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.
Time frame: Day of surgery
The fraction of patients receiving general versus spinal anesthesia will be compared during the pre-implementation versus active implementation periods.
Time frame: Postoperative day 30 to 90
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.
Time frame: Day of surgery
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
Time frame: Day of surgery
The percentage of eligible patients receiving the strategy during the sustainment phase
Time frame: Study months 12-27
Study clinicians' perceptions regarding sustainability of the intervention will be assessed during the implementation and sustainment phases via the 23-item NoMAD sustainability assessment.
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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