Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
Purpose
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
- Femoral Neck Fractures
- Intertrochanteric Fractures
- Subtrochanteric Fractures
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Stepped Wedge Cluster Randomized Trial
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Usual Care |
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. |
|
|
Active Comparator My Anesthesia Choice- HF |
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. |
|
Recruiting Locations
Gainesville, Florida 32608
Joshua Sappenfield
Detroit, Michigan 48202
Carlos Guerra Londono
Lebanon, New Hampshire 03766
Stacie G Deiner
Winston-Salem, North Carolina 27157
Lynette Harris, BSN
Cleveland, Ohio 44195
Sabry Ayad
Philadelphia, Pennsylvania 19104
James Baraldi, PhD
More Details
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
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 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.