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Coronary Artery Bypass Graft SurgeryNCT04527822

Discharge Planning Program for Post CABG Patients

A study testing Nurse led discharge planning program in people with Coronary Artery Bypass Graft Surgery and Mace, run by University of Jordan at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The current study is utilizing a nurse led discharge program based on the Re-Engineered Discharge program (Project-RED) ( Agency of Healthcare Research and Quality [AHRQ], 2013) which is a package of services designed to minimize discharge failures and minimize re-admissions, reduce mortality, morbidity, complication… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Nurse led discharge planning program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteJordan
Study dates
1 Aug 2020to 1 Jun 2024
Phase
Interventional
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient aged 21 years or older
  • Underwent first time isolated elective CABG surgery for single, double, or triple CAD.
  • Patient speak and read Arabic to eliminate any barriers of communication during the process of discharge and telephone call
  • Patient who has contact telephone number
  • Doesn't have Aortic calcification, and /or previous stroke
  • Welling to participate and Able to provide informed consent

Who cannot join

  • Adult patient aged 21 years or older
  • Underwent first time isolated elective CABG surgery for single, double, or triple CAD.
  • Patient speak and read Arabic to eliminate any barriers of communication during the process of discharge and telephone call
  • Patient who has contact telephone number
  • Doesn't have Aortic calcification, and /or previous stroke
  • Welling to participate and Able to provide informed consent

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • University of Jordan

    Amman, 11942

Other trials in Jordan

About this study

Official title: Effect of Discharge Planning Program on Patient's Outcomes Post Coronary Artery Bypass Graft Surgery

The current study is utilizing a nurse led discharge program based on the Re-Engineered Discharge program (Project-RED) ( Agency of Healthcare Research and Quality [AHRQ], 2013) which is a package of services designed to minimize discharge failures and minimize re-admissions, reduce mortality, morbidity, complication and improve patients outcomes. Project-RED aims to reduce hospital re-admissions through a series of structured steps led by a nurse called discharge advocate. The intervention will be used to discharge patients post Coronary artery bypass graft surgery.

Read the detailed description

Cardiovascular diseases (CVD) are the main threats to human lives (Benjamin et al., 2018). Around 17.9 million deaths worldwide were attributed to CVD (Benjamin et al., 2018); Which Represents 31 % of the global deaths (Benjamin et al., 2018). Coronary artery disease is one of the CVD. Coronary artery disease prevalence among United State (US) adults aged 20 years and above is 6.3 %. It is responsible for 43.8 % of the deaths worldwide. (Benjamin et al., 2018).

In Jordan, CVD is the leading cause of death. During 2016; 37 % of all deaths among Jordanian population were due to CVD. Coronary Artery Disease is responsible for 18 % of the deaths (Centers of Disease Control [CDC], 2016) Coronary artery diseases currently are managed with medical treatment, percutaneous coronary interventions (PCI) or Coronary artery bypass graft (CABG) surgery (Habib et al., 2015). Coronary artery bypass graft surgery is the indicated choice for multi-vessel coronary disease (Habib et al., 2015). It is defined as a revascularization procedure used for the treatment of CAD. It involves establishing a graft from another vessel of the body to bypass the narrowed coronary artery and restore blood flow to the cardiac muscle (Urden, Stacy, \& Lough, 2017).

Even though Coronary Artery Bypass Graft surgery is believed to provide more complete revascularization and leading to improved long term outcomes than PCI (Hillis et al., 2011); the recovery process after hospital discharge might be complicated by the occurrence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (Goldfarb et al., 2015). Major Adverse Cardiovascular and Cerebrovascular Events consist of mortality, myocardial infarction (MI), stroke and need for repeat revascularization (Goldfarb et al., 2015). Mortality leads to losing the patient after a major and costly surgery, while; MI, stroke and need for reopening or repeat revascularization leads to patient readmission to the hospital and might end up with increased mortality rate (Goldfarb et al., 2015; Hillis et al., 2011).

Mortality rate after CABG ranges from 1.1% -24 % (Grundeken et al., 2013; Jose et al., 2019; Shah et al., 2019; Wrobel et al., 2015). Among the Jordanian CABG population; all-cause mortality reported 30 day after surgery was 5.9 % in 1046 patients (AlWaqfi, Khader, \& Ibrahim, 2012).

The readmission rate of CABG patients within 30 days is seriously high (Feng, White, Gaber-Baylis, Turnbull, \& Rong, 2018). More specifically; Feng et al., (2018) reported that 28601 adult CABG patients out of 177229 (16 %) in the united States (US) were readmitted within 30 days (Feng et al., 2018). Another study revealed that more than 60 % of CABG patients readmissions occur within the first week post discharge (Price, Romeiser, Gnerre, Shroyer, \& Rosengart, 2013). Several reasons stand behind hospital readmissions after CABG surgery (Mary, 2017; Seifert, 2017). Price et al., (2013) reported that 25% of 13% hospital readmissions after CABG surgery were attributed to cardiac reasons.

Myocardial Infarction after CABG surgery is Type 5 MI (Thygesen et al., 2018). Shah et al., (2016) reported that out of 2215 CABG patients 5.8 % developed acute MI post-surgery while 3.8 % required repeat revascularization. Repeat revascularization is a new CABG or PCI procedure needs to be done due to documented ischemia or graft failure and it is one of the MACCE that might occur within 30 days after CABG surgery (Takagi et al., 2013). The incidence rate of repeated revascularization among CABG patient is ranging from 0.5 % -1.3 % (Deppe et al., 2016; Taggart et al., 2015; Wu et al., 2015) Stroke is an acute focal neurological deficit lasting ≥ 24 hours with or without confirmatory imaging (Goldfarb et al., 2015). Around 1.3% of CABG patients developed stroke after the surgery which causes near 20 % mortality rate perioperative (Gaudino et al., 2019). Among Jordanian population; CABG Patients who had stroke were 2.3 % of the sample (1046 patients). Of these; 33.3 % were died (AlWaqfi et al., 2012).

Reducing mortality and hospital readmission following cardiac surgery has become a national priority in the US and worldwide. Unclear discharge instructions and lack of follow up plans are among the reported reasons for hospital readmissions (Amoah \& Mwanri, 2016). Patient experience with discharge instructions show that patients who discharged with sufficient information and provided follow-up care were better in managing postoperative problems and experienced improved post discharge outcomes (M. Akbari \& Celik, 2015). Therefore; have a better health-related quality of life (HRQOL).

The current study intervention is a nurse led discharge program based on the Re-Engineered Discharge program (Project-RED) ( Agency of Healthcare Research and Quality [AHRQ], 2013) which is a package of services designed to minimize discharge failures and minimize readmissions (Jack et al., 2009; S. Mitchell, Weigel, Laurens, Martin, \& Jack, 2017; S. E. Mitchell et al., 2016; Patel \& Dickerson, 2018), reduce mortality, morbidity, complication (Ceppa et al., 2015) and improve patients outcomes (Adams, Stephens, Whiteman, Kersteen, \& Katruska, 2014; Berkowitz et al., 2013; Cancino et al., 2017) . Project-RED aims to reduce hospital readmissions through a series of structured steps led by a nurse called discharge advocate. (Jack et al., 2009)

Being tested
Nurse led discharge planning program
Keywords
Coronary artery bypass graft surgery CABGl, MACE, nursing care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse led discharge planning programOther

    a discharge planning program. It is a modified discharge planning program depends basically on the Re-Engineered Discharge program which is a program developed by Boston Medical Center in collaboration with AHRQ , 2013. The intervention consists of several components. The program components include making appointments for follow-up care (e.g., medical appointments and post discharge tests/labs). Plan for the follow-up of results from tests or labs that are pending at discharge. Identify the correct medicines and a plan for the patient to obtain them. Teach a written discharge plan the patient can understand. Educate the patient about his or her diagnosis and medicines. Review with the patient what to do if a problem arises. Assess the degree of the patient's understanding of the discharge plan and provide a telephone reinforcement of the discharge plan

Study groups in NCT04527822
Study groupRoleWhat they receive
Discharge planning programExperimentala discharge planning program. It is a modified discharge planning program depends basically on the Re-Engineered Discharge program which is a program developed by Boston Medical Center in collaboration with AHRQ , 2013. The intervention consists of several components. The program components include making appointments for follow-up care (e.g., medical appointments and post discharge tests/labs). Plan for the follow-up of results from tests or labs that are pending at discharge. Identify the correct medicines and a plan for the patient to obtain them. Teach a written discharge plan the patient can understand. Educate the patient about his or her diagnosis and medicines. Review with the patient what to do if a problem arises. Assess the degree of the patient's understanding of the discharge plan and provide a telephone reinforcement of the discharge plan
Receives: Other: Nurse led discharge planning program
Standard CareActive comparatorNot described
Receives: Other: Nurse led discharge planning program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular and cerebrovascular events

    The variable of MACCE includes MI, Stroke, and all-cause death and repeat re-vascularization

    Measured: 30 days

Secondary outcomes (1)
  1. Adherence to medications

    Adherence to medications

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 groups Post test only
Masking
None (open label)
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04527822
Sponsor's protocol ID
101271-2
Status last verified
Mar 2024
First submitted
22 Aug 2020
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nurse led discharge planning program in people with Coronary Artery Bypass Graft Surgery and Mace, run by University of Jordan at 1 site in Jordan.

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 6 inclusion and 6 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular and cerebrovascular events (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Mar 2024.

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