Cardiac Surgery Sternal Precautions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care

Conditions
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Surgery, Heart Diseases, Heart Failure, Cardiac Valve Disease

Intervention / Treatment
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* Other: Self Managed Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently Exclusion Criteria: Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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. | Other: Self Managed Care<br>* Self Managed Care<br>|
| Active Comparator: Arm 2<br>Arm 2 will receive the standard sternal precautions at time of post operative discharge. | Other: Self Managed Care<br>* Self Managed Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Precaution Checklist | Assessing patients' adherence to protocol | Patient will be called weekly for 8 weeks by a medical professional. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Precautions- Quality of Life Questions | Assessing patients' postoperative quality of life | Patient will be called weekly for 8 weeks by a medical professional. | 
| Sternal Precaution Pain Scale | Assessing patients' postoperative pain | Patient will be called weekly for 8 weeks by a medical professional. |