Clinical trial NCT05206929: Prescribed Sternal Precautions vs. Self-Guided Restrictive Care (PEEERC)
Official title: A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Heart Diseases
Heart Failure
Cardiac Valve Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sternal Precaution Checklist
timeFrame: Patient will be called weekly for 8 weeks by a medical professional.
Secondary outcomes:
measure: Sternal Precautions- Quality of Life Questions
timeFrame: Patient will be called weekly for 8 weeks by a medical professional.
measure: Sternal Precaution Pain Scale
timeFrame: Patient will be called weekly for 8 weeks by a medical professional.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: Professor of Surgery
name: Valluvan Jeevanandam, MD
role: PRINCIPAL_INVESTIGATOR
References: