Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,881
- 试验地点
- 11
- 主要终点
- Intervention reach (primary implementation outcome)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 and older Planned surgery to treat a hip fracture
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: My Anesthesia Choice-HF Model (Behavioral)
结局指标
主要结局
Intervention reach (primary implementation outcome)
时间窗: 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)
时间窗: 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
次要结局
- CollaboRATE shared decision making scale score (secondary effectiveness outcome).(Postoperative day 0-3)
