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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| University of Florida | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| Henry Ford Health System |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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. | |
| My Anesthesia Choice- HF | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Anesthesia Choice-HF Model | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Knowledge regarding anesthesia options |
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Neuman, MD | Contact | 215-746-7468 | neumanm@pennmedicine.upenn.edu | |
| Karah Whatley | Contact | karah.whatley@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Neuman, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Gainesville | Recruiting | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39267183 | Derived | Goldstein EC, Politi MC, Baraldi JH, Elwyn G, Campos H, Feng R, Mehta S, Whatley K, Schmitz V, Neuman MD. Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3. |
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| OTHER |
| The Cleveland Clinic | OTHER |
| Dartmouth College | OTHER |
| Washington University School of Medicine | OTHER |
Stepped Wedge Cluster Randomized Trial
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Sustainment of intervention | The percentage of eligible patients receiving the strategy during the sustainment phase | Day of surgery |
| 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 |
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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| Wake Forest University Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Cleveland Clinic-Fairview | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005265 | Femoral Neck Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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