Cardiac Surgery, ReadmissionNCT06038266
Predictors of Hospital Readmission for Patients Undergoing Cardiac Surgeries
An observational study of Cardiac Surgery, Readmission, run by Assiut University.
Trial summary
This study aimed to identify the predictors of hospital readmission for patients undergoing cardiac surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Surgery, Readmission
- What is being tested?
- cardiac surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study will include a sample of 121 adult patients (male and female) who are undergoing CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years old.
Who may be able to join
- The study will include a sample of 121 adult patients (male and female) who are undergoing CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years old.
Who cannot join
- Failed surgery
- Psychiatric patient
- Patient refusal to participate in the study
- Aortic surgeries
Trial locations and contacts
No sites are listed yet.
About this study
This study aimed to identify the predictors of hospital readmission for patients undergoing cardiac surgeries.
Read the detailed description
Cardiovascular diseases (CVDs) are conditions of the heart and blood vessels that lead to significant morbidity and mortality, burden the global public health system, and are the main cause of death worldwide. CVD accounted for approximately 19.05 million global deaths in 2020. CVD is listed as the first underlying cause of death, with more than 800000 deaths in the United States in 2019. Between 2015 and 2018, 126.9 million US adults had some form of CVD. Between 2017 and 2018, direct and indirect costs of total CVD were $378.0 billion ($226.2. billion in direct costs and $151.8 billion in lost productivity/mortality).
Cardiac surgery continues to play an important role in the management of various cardiovascular disorders, including the treatment of seriously and critically ill patients. The most frequently performed procedures include coronary artery bypass graft (CABG) and valvular surgery. According to the Society of Thoracic Surgeons, the number of cardiac surgeries exceeds 300000 procedures in 2019 in the United States. Despite tremendous advancements in cardiac surgery over the past few years, postoperative hospital readmissions after cardiac surgeries still present significant challenges.
Readmission occurs when a patient is admitted to the same or a different hospital after being discharged from the relevant hospital and placed in a non-acute setting, such as his home, within a predetermined amount of time. Readmission within 30 days of adult cardiac surgery is a difficult and costly problem, with rates ranging from 8% to 21%. In addition to delayed return to activities of daily living and reduced quality of life, readmission is associated with a financial cost for patients and healthcare facilities. Increased facility costs can be substantial, especially when combined with reimbursement penalties, the cost of skilled care, and potential legal expenses.
Readmission after cardiac surgery is common and moderately predictable. According to a study done in a multi-institutional hospital in Ontario, Canada on patients who underwent CABG and/or valve surgery from 2008 to 2016, the 30-day readmission rate was 11.5% overall. Patients who were readmitted were older with higher incidences of cardiac comorbidities compared with non-readmitted patients. Significant risk factors for readmission from the final model were the prolonged length of stay, isolated valve surgery, in-hospital complications of sepsis, acute myocardial infarction, diabetes mellitus, gastrointestinal problems wound infection, postoperative acute renal failure, atrial fibrillation (AF), chronic lung disease, obesity, hematocrit <35% before surgery, cardiopulmonary bypass, especially bypass durations of more than 100 minutes.
Perioperative nurses may positively affect reducing readmission rates at different stages of the perioperative continuum of care. All nursing interventions play an important role in minimizing patient risk and preventing or reducing the number of readmissions. Nursing strategies to reduce postoperative cardiac surgery readmission include central line and urinary catheter insertion, cardiopulmonary bypass circuit maintenance, temperature regulation, hair removal, and skin preparation, glycemic control, care of the incision site, treatment and prevention of dysrhythmia, pleural effusion and retained blood syndrome, appropriate discharge teaching, following up with the patients after discharge through telephone conversations and post-discharge care.
Reducing readmission after cardiac surgery remains a quality improvement priority. most readmission risk models examine only coronary artery bypass grafting (CABG). So, this study will be carried out to identify predictors of patients' postoperative readmission after cardiac surgery, including CABG \& valvular surgeries.
- Conditions
- Cardiac Surgery, Readmission
- Being tested
- cardiac surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeriesProcedure or surgery
predict perioperative risk factors for readmission after cardiac surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
detect perioperative risk factors for hospital readmission in patients whose undergoing cardiac surgeries
analysis of pre, intra and postoperative risk factors that may cause readmission for patients undergoing Valvular surgery or Coronary artery bypass grafting (CABG)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery, ReadmissionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Fathy Abdelhafeez Soliman, Assiut University
- Investigators
- Marwa Ali Almasry, Ass.Prof, Study director, Assistant professor of medical surgical nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038266
- Sponsor's protocol ID
- PHR for Cardiac Surgery
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iribarne A, Chang H, Alexander JH, Gillinov AM, Moquete E, Puskas JD, Bagiella E, Acker MA, Mayer ML, Ferguson TB, Burks S, Perrault LP, Welsh S, Johnston KC, Murphy M, DeRose JJ, Neill A, Dobrev E, Baio KT, Taddei-Peters W, Moskowitz AJ, O'Gara PT. Readmissions after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health research cardiothoracic surgical trials network. Ann Thorac Surg. 2014 Oct;98(4):1274-80. doi: 10.1016/j.athoracsur.2014.06.059. Epub 2014 Aug 28.
PubMed 25173721Seifert PC. Reducing Readmissions After Coronary Artery Bypass Grafting. AORN J. 2017 Oct;106(4):332-337. doi: 10.1016/j.aorn.2017.08.009. No abstract available.
PubMed 28958319Ferraris VA, Ferraris SP, Harmon RC, Evans BD. Risk factors for early hospital readmission after cardiac operations. J Thorac Cardiovasc Surg. 2001 Aug;122(2):278-86. doi: 10.1067/mtc.2001.114776.
PubMed 11479500Demissie, D. B., Doge, G., & Werba, T. B. (2023). The Magnitude of 30-Day Readmission and Factors Associated with Patients Underwent Cardiac Surgery in Tikur Anbessa Specialized Hospital Cardiac Center, Ethiopia. Research Reports in Clinical Cardiology, Volume 14, 35-48. https://doi.org/10.2147/rrcc.s407183
Stephens RS, Whitman GJ. Postoperative Critical Care of the Adult Cardiac Surgical Patient. Part I: Routine Postoperative Care. Crit Care Med. 2015 Jul;43(7):1477-97. doi: 10.1097/CCM.0000000000001059.
PubMed 25962078
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Hospital Readmission for Patients Undergoing Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT06038266
- Acronym / sponsor ID
- PHR for Cardiac Surgery
- Conditions
- Cardiac Surgery, Readmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to identify the predictors of hospital readmission for patients undergoing cardiac surgeries.
Detailed description
Cardiovascular diseases (CVDs) are conditions of the heart and blood vessels that lead to significant morbidity and mortality, burden the global public health system, and are the main cause of death worldwide. CVD accounted for approximately 19.05 million global deaths in 2020. CVD is listed as the first underlying cause of death, with more than 800000 deaths in the United States in 2019. Between 2015 and 2018, 126.9 million US adults had some form of CVD. Between 2017 and 2018, direct and indirect costs of total CVD were $378.0 billion ($226.2. billion in direct costs and $151.8 billion in lost productivity/mortality).
Cardiac surgery continues to play an important role in the management of various cardiovascular disorders, including the treatment of seriously and critically ill patients. The most frequently performed procedures include coronary artery bypass graft (CABG) and valvular surgery. According to the Society of Thoracic Surgeons, the number of cardiac surgeries exceeds 300000 procedures in 2019 in the United States. Despite tremendous advancements in cardiac surgery over the past few years, postoperative hospital readmissions after cardiac surgeries still present significant challenges.
Readmission occurs when a patient is admitted to the same or a different hospital after being discharged from the relevant hospital and placed in a non-acute setting, such as his home, within a predetermined amount of time. Readmission within 30 days of adult cardiac surgery is a difficult and costly problem, with rates ranging from 8% to 21%. In addition to delayed return to activities of daily living and reduced quality of life, readmission is associated with a financial cost for patients and healthcare facilities. Increased facility costs can be substantial, especially when combined with reimbursement penalties, the cost of skilled care, and potential legal expenses.
Readmission after cardiac surgery is common and moderately predictable. According to a study done in a multi-institutional hospital in Ontario, Canada on patients who underwent CABG and/or valve surgery from 2008 to 2016, the 30-day readmission rate was 11.5% overall. Patients who were readmitted were older with higher incidences of cardiac comorbidities compared with non-readmitted patients. Significant risk factors for readmission from the final model were the prolonged length of stay, isolated valve surgery, in-hospital complications of sepsis, acute myocardial infarction, diabetes mellitus, gastrointestinal problems wound infection, postoperative acute renal failure, atrial fibrillation (AF), chronic lung disease, obesity, hematocrit <35% before surgery, cardiopulmonary bypass, especially bypass durations of more than 100 minutes.
Perioperative nurses may positively affect reducing readmission rates at different stages of the perioperative continuum of care. All nursing interventions play an important role in minimizing patient risk and preventing or reducing the number of readmissions. Nursing strategies to reduce postoperative cardiac surgery readmission include central line and urinary catheter insertion, cardiopulmonary bypass circuit maintenance, temperature regulation, hair removal, and skin preparation, glycemic control, care of the incision site, treatment and prevention of dysrhythmia, pleural effusion and retained blood syndrome, appropriate discharge teaching, following up with the patients after discharge through telephone conversations and post-discharge care.
Reducing readmission after cardiac surgery remains a quality improvement priority. most readmission risk models examine only coronary artery bypass grafting (CABG). So, this study will be carried out to identify predictors of patients' postoperative readmission after cardiac surgery, including CABG \& valvular surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include a sample of 121 adult patients (male and female) who are undergoing CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years old.
Key inclusion criteria (1 listed)
- The study will include a sample of 121 adult patients (male and female) who are undergoing CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years old.
Key exclusion criteria (4 listed)
- Failed surgery
- Psychiatric patient
- Patient refusal to participate in the study
- Aortic surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgeriespredict perioperative risk factors for readmission after cardiac surgeries | Procedure or surgery | – |
Primary outcome
detect perioperative risk factors for hospital readmission in patients whose undergoing cardiac surgeries
Time frame: baseline
analysis of pre, intra and postoperative risk factors that may cause readmission for patients undergoing Valvular surgery or Coronary artery bypass grafting (CABG)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 25173721Iribarne A, Chang H, Alexander JH, Gillinov AM, Moquete E, Puskas JD, Bagiella E, Acker MA, Mayer ML, Ferguson TB, Burks S, Perrault LP, Welsh S, Johnston KC, Murphy M, DeRose JJ, Neill A, Dobrev E, Baio KT, Taddei-Peters W, Moskowitz AJ, O'Gara PT. Readmissions after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health research cardiothoracic surgical trials network. Ann Thorac Surg. 2014 Oct;98(4):1274-80. doi: 10.1016/j.athoracsur.2014.06.059. Epub 2014 Aug 28.
- Background: PubMed 28958319Seifert PC. Reducing Readmissions After Coronary Artery Bypass Grafting. AORN J. 2017 Oct;106(4):332-337. doi: 10.1016/j.aorn.2017.08.009. No abstract available.
- Background: PubMed 11479500Ferraris VA, Ferraris SP, Harmon RC, Evans BD. Risk factors for early hospital readmission after cardiac operations. J Thorac Cardiovasc Surg. 2001 Aug;122(2):278-86. doi: 10.1067/mtc.2001.114776.
- BackgroundDemissie, D. B., Doge, G., & Werba, T. B. (2023). The Magnitude of 30-Day Readmission and Factors Associated with Patients Underwent Cardiac Surgery in Tikur Anbessa Specialized Hospital Cardiac Center, Ethiopia. Research Reports in Clinical Cardiology, Volume 14, 35-48. https://doi.org/10.2147/rrcc.s407183
- Background: PubMed 25962078Stephens RS, Whitman GJ. Postoperative Critical Care of the Adult Cardiac Surgical Patient. Part I: Routine Postoperative Care. Crit Care Med. 2015 Jul;43(7):1477-97. doi: 10.1097/CCM.0000000000001059.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Ali Almasry, Ass.Prof study director
Assistant professor of medical surgical nursing
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, Readmission, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud FathI Abdelhafeez Soliman, BSN (+201006579808, mahmoud808@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect perioperative risk factors for hospital readmission in patients whose undergoing cardiac surgeries (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038266, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.