Medication ReconciliationNCT01065675
Medication Histories Conducted by Nurses (RNs), Pharmacy Techs (CPhTs) & Pharmacists (RPhs)
A study testing Medication reconciliation completed by a RN, CPhT, or RPh in people with Medication Reconciliation and Emergency Department, run by Wesley Medical Center at 1 site in United States.
Trial summary
Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital setting are estimated to be related to communication issues regarding patient medications at various transition points of care from admission to discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Reconciliation, Emergency Department
- What is being tested?
- Medication reconciliation completed by a RN, CPhT, or RPh
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted as inpatients from the Emergency Department
Who cannot join
- Prisoners (because the IRB does not have a prisoner representative)
- Patients not admitted as inpatients through the Emergency Department
- Patients admitted more than once during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Patient Triage Development and Implementation Involving Nurse (RN), Pharmacy Technician (CPhT), and Pharmacist (RPh) Obtained Medication Histories in the Emergency Department (ED)and Impact on Medication Reconciliation
Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital setting are estimated to be related to communication issues regarding patient medications at various transition points of care from admission to discharge. The Joint Commission (TJC) requires accurate and complete medication reconciliation occur at each transition point throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most effective medication management team leaders in the implementation of medication management practices and design of medication error reduction strategies; medication reconciliation is one of the five safety objectives pharmacists are recommended to lead. In addition, the Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate medication histories.
WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication error rate on admission determined by comparing the nurse-obtained medication history to the pharmacist-obtained medication history. The number of home medications identified by the pharmacist compared to the nurse was 411 versus 312 (p<0.0001). The total percentage of medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12 (major/probable), if the discrepancies would not have been identified and corrected by the pharmacist conducting the admission medication reconciliation audit. The same patients' discharge medication reconciliation and discharge medication lists were retrospectively reviewed for the MUE, and the total percentage of patients with medication errors on discharge was 43%.
- Conditions
- Medication Reconciliation, Emergency Department
- Being tested
- Medication reconciliation completed by a RN, CPhT, or RPh
- Keywords
- Medication Reconciliation, Emergency Department, Nurse, Pharmacist, Certified Pharmacy Technician, Medication reconciliation: inpatients admitted from the ED
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliation completed by a RN, CPhT, or RPhOther
Also called Medication Reconciliation, Pharmacist, Nurse, Certified Pharmacy Technician
To determine which patients benefit the most from medication histories obtained by the RN, CPhT, or RPh. Patients will be admitted as inpatients through the ED with medication histories finalized electronically by the RN at the admitting unit.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which patients benefit most from medication histories obtained by the RN, CPhT, or RPh based on accuracy (% complete disease states, allergy documentation and description, vaccination documentation, medication documentation)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionMay 2011
Why it stopped: Statistical analysis of 153 enrolled Phase 1 patients showed that specific patients could not be targeted for medication histories by discipline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ReconciliationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wesley Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Health
- Responsible party
- Principal investigator, Joan Kramer, Wesley Medical Center
- Investigators
- Joan S Kramer, PharmD, Principal investigator, Wesley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065675
- Sponsor's protocol ID
- 09-068
- Status last verified
- Dec 2012
- First submitted
- 3 Feb 2010
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Patient Triage Development and Implementation Involving Nurse (RN), Pharmacy Technician (CPhT), and Pharmacist (RPh) Obtained Medication Histories in the Emergency Department (ED)and Impact on Medication Reconciliation
- ClinicalTrials.gov ID
- NCT01065675
- Acronym / sponsor ID
- 09-068
- Conditions
- Medication Reconciliation, Emergency Department
- Keywords
- Medication Reconciliation, Emergency Department, Nurse, Pharmacist, Certified Pharmacy Technician, Medication reconciliation: inpatients admitted from the ED
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Statistical analysis of 153 enrolled Phase 1 patients showed that specific patients could not be targeted for medication histories by discipline.
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Wesley Medical CenterUniversity, hospital or other
- Collaborators
- Cardinal Health
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Feb 2010 (estimated)
- 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.
Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital setting are estimated to be related to communication issues regarding patient medications at various transition points of care from admission to discharge. The Joint Commission (TJC) requires accurate and complete medication reconciliation occur at each transition point throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most effective medication management team leaders in the implementation of medication management practices and design of medication error reduction strategies; medication reconciliation is one of the five safety objectives pharmacists are recommended to lead. In addition, the Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate medication histories.
WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication error rate on admission determined by comparing the nurse-obtained medication history to the pharmacist-obtained medication history. The number of home medications identified by the pharmacist compared to the nurse was 411 versus 312 (p<0.0001). The total percentage of medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12 (major/probable), if the discrepancies would not have been identified and corrected by the pharmacist conducting the admission medication reconciliation audit. The same patients' discharge medication reconciliation and discharge medication lists were retrospectively reviewed for the MUE, and the total percentage of patients with medication errors on discharge was 43%.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted as inpatients from the Emergency Department
Key exclusion criteria (3 listed)
- Prisoners (because the IRB does not have a prisoner representative)
- Patients not admitted as inpatients through the Emergency Department
- Patients admitted more than once during the study period
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 |
|---|---|---|
| Medication reconciliation completed by a RN, CPhT, or RPhAlso: Medication Reconciliation, Pharmacist, Nurse, Certified Pharmacy TechnicianTo determine which patients benefit the most from medication histories obtained by the RN, CPhT, or RPh. Patients will be admitted as inpatients through the ED with medication histories finalized electronically by the RN at the admitting unit. | Other | – |
Primary outcome
To determine which patients benefit most from medication histories obtained by the RN, CPhT, or RPh based on accuracy (% complete disease states, allergy documentation and description, vaccination documentation, medication documentation)
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Statistical analysis of 153 enrolled Phase 1 patients showed that specific patients could not be targeted for medication histories by discipline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2012.
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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.
Joan S Kramer, PharmD principal investigator
Wesley Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reconciliation completed by a RN, CPhT, or RPh in people with Medication Reconciliation and Emergency Department, run by Wesley Medical Center 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Dec 2012. 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 was stopped early (reason given: Statistical analysis of 153 enrolled Phase 1 patients showed that specific patients could not be targeted for medication histories by discipline.). 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?
To determine which patients benefit most from medication histories obtained by the RN, CPhT, or RPh based on accuracy (% complete disease states, allergy documentation and description, vaccination documentation, medication documentation) (time frame: 5 months). 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 28 Dec 2012.