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Prescribed Sternal Precautions vs. Self-Guided Restrictive Care (PEEERC)

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The University of Chicago

Status

Terminated

Conditions

Surgery
Heart Failure
Heart Diseases
Cardiac Valve Disease

Treatments

Other: Self Managed Care

Study type

Interventional

Funder types

Other

Identifiers

NCT05206929
IRB20-1339

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Arm 1
Experimental group
Description:
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.
Treatment:
Other: Self Managed Care
Arm 2
Active Comparator group
Description:
Arm 2 will receive the standard sternal precautions at time of post operative discharge.
Treatment:
Other: Self Managed Care

Trial contacts and locations

1

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Central trial contact

Leila Yazdanbakhsh; Carlisa Dixon

Data sourced from clinicaltrials.gov

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