A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Sternal Precaution Checklist
研究概览
简要总结
Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.
详细描述
Patients who are recruited in this study will be randomized (1:1) into one of two groups/arms. The ?rst arm (Arm 1) will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge. The second arm (Arm 2) will receive the standard sternal precautions at time of post operative discharge. Standard sternal precautions in study arm (2) include:
Don't reach both arms overhead Don't reach both arms out to the side Don't reach behind your back Don't lift more than 5 to 8 pounds Don't push with your arms Don't pull with your arms Don't drive
Each arm will receive weekly phone calls for 8 weeks. Information including pain, quality of life, and adherence to the sternal precaution protocol will be collected. Please refer to supporting documents (Pain Scale, Quality of Life Questionnaire, and Sternal Precaution Checklist) for the specific questions that will be asked at the patients. We will also investigate any adverse events related to the medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently
排除标准
- •Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy
研究组 & 干预措施
Arm 1
Arm 1 will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge.
干预措施: Self Managed Care (Other)
Arm 2
Arm 2 will receive the standard sternal precautions at time of post operative discharge.
干预措施: Self Managed Care (Other)
结局指标
主要结局
Sternal Precaution Checklist
时间窗: Patient will be called weekly for 8 weeks by a medical professional.
Assessing patients' adherence to protocol
次要结局
- Sternal Precautions- Quality of Life Questions(Patient will be called weekly for 8 weeks by a medical professional.)
- Sternal Precaution Pain Scale(Patient will be called weekly for 8 weeks by a medical professional.)