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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438640
• Other study ID #: 855203
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: May 15, 2028

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Mark Neuman, MD
• Phone: 215-746-7468
• Email: neumanm[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3548
• Est. completion date: May 15, 2028
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

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)

Locations

Country	Name	City	State
United States	Cleveland Clinic-Fairview	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida Gainesville	Gainesville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (8)

Lead Sponsor	Collaborator
University of Pennsylvania	Dartmouth College, Dartmouth-Hitchcock Medical Center, Henry Ford Health System, The Cleveland Clinic, University of Florida, Wake Forest University Health Sciences, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Sustainment of intervention	The percentage of eligible patients receiving the strategy during the sustainment phase	Day of surgery
Other	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
Primary	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
Primary	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	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