Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04527822 |
| Other study ID # |
101271-2 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Jordan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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)
