Adverse Drug EventNCT04181775
Effectiveness of an ADE-related Hospitalization Risk Prediction Tool for Patients (ADE-RED)
An observational study of Adverse Drug Event, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- ADE-RED scoring tool
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 22 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are considered high risk if the score is > 12, moderate risk if the score 6-11, and low risk if the score is 0-5. High-risk patients are flagged in the electronic medical record of the patient, alerting the pharmacist to complete a medication reconciliation and address any issues.
Who may be able to join
- Patients admitted to the hospital with a prior ED visit within the previous 30 days
- Patients presenting to the ED with a prior ED visit within the previous 30 days
Who cannot join
- Patients without PTA medications at the time of initial ED presentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Effectiveness of an ADE-related Hospitalization Risk Prediction Tool for Patients Discharged From the Emergency Department (ADE-RED)
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.
Read the detailed 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.
- Conditions
- Adverse Drug Event
- Being tested
- ADE-RED scoring tool
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADE-RED scoring toolDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of ADE-related readmission within 30 days of prior ED visit.
Incidences of ADE-related readmission within 30 days of prior ED visit.
Measured: one month period in March 2019
Secondary outcomes (1)
Percentage of patients who were readmitted who did or did not have an ADE-RED score at initial ED visit.
Percentage of patients who were readmitted who did or did not have an ADE-RED score at initial ED visit.
Measured: one month period in March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start8 Nov 2019
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilka Ratsaphangthong, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181775
- Sponsor's protocol ID
- 060.PHA.2019.A
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an ADE-related Hospitalization Risk Prediction Tool for Patients Discharged From the Emergency Department (ADE-RED)
- ClinicalTrials.gov ID
- NCT04181775
- Acronym / sponsor ID
- 060.PHA.2019.A
- Conditions
- Adverse Drug Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 29 Nov 2019 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are considered high risk if the score is > 12, moderate risk if the score 6-11, and low risk if the score is 0-5. High-risk patients are flagged in the electronic medical record of the patient, alerting the pharmacist to complete a medication reconciliation and address any issues.
Key inclusion criteria (2 listed)
- Patients admitted to the hospital with a prior ED visit within the previous 30 days
- Patients presenting to the ED with a prior ED visit within the previous 30 days
Key exclusion criteria (1 listed)
- Patients without PTA medications at the time of initial ED presentation
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 |
|---|---|---|
| ADE-RED scoring toolThe 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. | Diagnostic test | – |
Primary outcome
Incidences of ADE-related readmission within 30 days of prior ED visit.
Time frame: one month period in March 2019
Incidences of ADE-related readmission within 30 days of prior ED visit.
1 secondary outcome
Percentage of patients who were readmitted who did or did not have an ADE-RED score at initial ED visit.
Time frame: one month period in March 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ilka Ratsaphangthong, PharmD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Event, run by Methodist Health System at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Mar 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidences of ADE-related readmission within 30 days of prior ED visit. (time frame: one month period in March 2019). 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 24 Mar 2026.