Femoral Neck Fractures, Hip Fractures, Intertrochanteric Fractures, Subtrochanteric Fractures
Conditions
Keywords
hip fracture, femoral neck, intertrochanteric, subtrochanteric, fracture, anesthesia, observational study, survey, shared decision making, My Anesthesia Choice, MAC-HF
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 34 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 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.
Interventions
BEHAVIORALMy 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)
Sponsors
University of Pennsylvania
Wake Forest University Health Sciences
University of Florida
Dartmouth-Hitchcock Medical Center
Henry Ford Health System
The Cleveland Clinic
Dartmouth College
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped Wedge Cluster Randomized Trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention reach (primary implementation outcome) | 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. |
| Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CollaboRATE shared decision making scale score (secondary effectiveness outcome). | 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 |
Countries
United States
Contacts
CONTACTMark Neuman, MD
CONTACTKarah Whatley
PRINCIPAL_INVESTIGATORMark Neuman, MD
University of Pennsylvania
Outcome results
None listed