Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04181775 |
| Other study ID # |
060.PHA.2019.A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2019 |
| Est. completion date |
June 22, 2020 |
Study information
| Verified date |
November 2021 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The rationale for this study is to evaluate the effectiveness of a risk prediction tool for
patients who are at high risk for ADEs resulting in hospitalization or ED revisit. The
ADE-RED score initiates a PLMR that literature has shown reduces medication discrepancies and
ADEs at hospital admission and discharge. No current system identifies patients presenting to
the ED that may benefit from PMLR independent of an admission disposition. The ADE-RED
scoring tool will reduce the incidence of future visits to the ED or future admissions by
identifying patients who are at high risk for ADE-related readmissions.
Description:
There has been considerable attention placed on adverse drug events (ADEs) and their effects
on readmission rates worldwide. Several studies have tried to identify the drugs most
commonly responsible for ADEs, high-risk patient populations, and the causes of these ADEs.
Some of the causes that have been postulated include the aging population, increasing number
of drugs on the market, and a troubling upward trend in polypharmacy. The reported rates of
ADE-related hospitalizations have varied from study to study. Kongkaew et al. estimated
around 5% of all hospital admissions are the result of an adverse drug reaction (ADR), which
is a subtype of ADEs. Meanwhile, Shehab et al. estimated approximately 27.3% of emergency
department (ED) visits for ADEs result in hospitalization.
Unfortunately, practitioners may exacerbate the problem by prescribing additional
pharmacotherapy for conditions caused by an unrecognized ADE. Such circumstances can lead to
additional cost and harm to patients. However, pharmacists are uniquely qualified to
recognize and address potential ADEs through pharmacist-led medication reconciliation (PLMR).
PLMR is the process in which a pharmacist produces an accurate list of medications a patient
is taking and compares that list against the patient's documented admission, transfer, and/or
discharge orders. Several years of education and training to learn the pharmacokinetic and
pharmacokinetic characteristics of a wide variety of medications, as well as any potential
side effects, have given pharmacists the skills to detect, assess, and understand ADEs. Many
institutions have implemented PLMRs within specific hospital units, such as the ED, in an
effort to increase cost savings to the patient and the health care institution.
A meta-analysis of patients with preventable ADEs found that as much as 52% of ADEs, present
at the time of hospitalization or an emergency visit, were preventable (8). This highlights
the need to produce a tool to predict patients at risk for ADE-related hospitalizations.
There have been several ADE risk prediction initiatives developed to identify high risk
patients (9-17). Many of these risk prediction tools, such as the Prediction of
Hospitalization due to ADRs in Elderly Community-Dwelling Patients (PADR-EC) score and the
Brighton Adverse Drug Reactions Risk (BADRI) model, focused on older patients, hospitalized
patients, or both. A focus on prediction tools in older adults is reasonable due to
ADE-related hospitalization rates among adults 65 years or older, being seven times higher
than adults younger than 65 years old (6). However, there is limited information in risk
scoring tools for the general public who present to the ED and are at high risk of an ADE. In
2017, a Transitions of Care pharmacy resident at Methodist Dallas Medical Center (MDMC)
developed a risk scoring tool to help identify patients in the ED who were at high risk for
an ADE-related hospitalization. The scoring tool, which was named the ADE-RED score, took
into account the patient's age, presence of polypharmacy, specific high- risk medications,
number of previous ED visits, comorbidities, and the reason for their current visit. A score
of 12 or more alerted ED pharmacists to perform a PLMR and to make necessary interventions
and recommendations to medical staff. Therefore the ADE-RED program has the opportunity to
fill a gap in the care for patients who may be hospitalized or return to the ED due to a
preventable ADE.
This study will be conducted to determine whether the ADE-RED score can reduce the incidence
of ADE- related readmissions compared to the incidence of such readmissions as observed from
sister facilities within the Methodist Health System (MHS) and to determine whether the
ADE-RED score can predict patients at risk of readmission.
